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Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book
November 2023 training courses
Pharmacovigilance Aspects of Licensing Agreements
29-30 Nov 2023 - Online webinar
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
29-30 Nov 2023 - Online webinar
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Medical Device Single Audit Programme (MDSAP)
30 Nov-1 Dec 2023 - Online webinar
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
December 2023 training courses
A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
4-5 Dec 2023 - Online webinar
Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China
Presented by
Bo Yang (bio)
and 4 more leading experts
Project Management for Pharma Professionals
4-5 Dec 2023 - Online webinar
The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
Includes: Interactive workshop sessions
Presented by Laura Brown (bio)
Biotechnology for the Non-Biotechnologist
4-8 Dec 2023 - Online webinar
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Robert Alvarez (bio)
and 6 more leading experts
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
11-14 Dec 2023 - Online webinar
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Medical Device Regulation in the Eurasian Union, Russia and the CIS
11-12 Dec 2023 - Online webinar
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Presented by Anna Harrington-Morozova (bio)
Advanced Pharmacovigilance
11-15 Dec 2023 - Online webinar
This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.
Presented by Graeme Ladds (bio)
Pharmaceutical Regulatory Affairs in China
12-13 Dec 2023 - Online webinar
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Veterinary Pharmaceutical Submissions in the EU
12-13 Dec 2023 - London
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, critical expert reports and regulatory submissions.
Best Practice for Writing Effective SOPs
14 Dec 2023 - Online webinar
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
CAPA (Corrective and Preventative Action)
15 Dec 2023 - Online webinar
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement, and planning and implementation in process improvements and CAPA.
Presented by Laura Brown (bio)
January 2024 training courses
Managing Vendor/CRO/CMO Oversight
15-16 Jan 2024 - Online webinar
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
Consultative Selling for Pharma Professionals
15-16 Jan 2024 - Online webinar
In this two-day, selling for pharma professionals training course, Robert Hersowitz leads participants through a four step process guaranteed to foster influence and encourage commitment from clients.
Presented by Robert Hersowitz (bio)
IP Department Roadmap
15 Jan 2024 - Online webinar
This course provides a step-by-step, matrix-based methodology with a top-down and cross-functional approach to design an IP department roadmap
Presented by Arnaud Gasnier (bio)
Process Validation with Qualification
16-17 Jan 2024 - Online webinar
Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.
Presented by Bruce Davis (bio)
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
17-18 Jan 2024 - Online webinar
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Presented by Janette Benaddi (bio)
Registration of Veterinary Vaccines in the USA and Canada
17-18 Jan 2024 - Online webinar
This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.
Presented by Nick Wills (bio)
A Practical Guide to Writing Risk Management Plans (RMPs)
18 Jan 2024 - Online webinar
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
A Practical Guide to Producing and Maintaining the PSMF
19 Jan 2024 - Online webinar
This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.
Presented by Graeme Ladds (bio)
An Essential Overview of the Pharmaceutical and Biotech Industries
19 Jan 2024 - Online webinar
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
Presented by Laura Brown (bio)
Clinical Trial Regulatory Requirements
22-23 Jan 2024 - Online webinar
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation one year on and a brief review of key FDA requirements.
Presented by Laura Brown (bio)
Advanced Veterinary Pharmacovigilance
22-25 Jan 2024 - Online webinar
Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit
Presented by Declan O'Rourke (bio)
Pharmacovigilance QMS & Inspection Preparation
22-25 Jan 2024 - Online webinar
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
Understanding Pharmacovigilance Regulations in APAC
23-24 Jan 2024 - Online webinar
Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.
Presented by
Param Dayal (bio)
and 4 more leading experts
Effective Technology Transfer
23-24 Jan 2024 - Online webinar
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
An Introduction to Health & Safety - how to identify and avoid safety management icebergs
23 Jan 2024 - Online webinar
An essential guide for directors, managers, and all those with health & safety responsibilities within a business.
Presented by Andy Farrall (bio)
Sustainable Design and Manufacture for Medical Devices
23 Jan 2024 - Online webinar
Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.
Presented by Cormac O'Prey (bio)
Artificial Intelligence and Machine Learning Powered Signal Management
24 Jan 2024 - Online webinar
This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.
Presented by Sanjeev Srivastav (bio)
Managing Remote Teams
24 Jan 2024 - Online webinar
During this programme you will learn how to adapt your management style for remote team working. You will explore ways to communicate and better understand how to monitor and evaluate your team as well as explore the recruitment implications of managing a remote team.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Workplace Accident Management and Investigation - from emergency planning to the final report
24 Jan 2024 - Online webinar
This masterclass will equip you with the skills and knowledge required to successfully manage an accident scene and undertake accident investigations in a workplace environment.
Presented by Andy Farrall (bio)
Organisational Storytelling for Successful Business Leaders
24 Jan 2024 - Online webinar
A two-part deep dive into the benefits of storytelling for your organisation. Develop your skills to deliver engaging presentations to connect with people in an impactful way.
Presented by Helene Russell (bio)
EU Proposed Pharmaceutical Legislation Changes
24 Jan 2024 - Online webinar
On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation.
This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.
Presented by Norah Lightowler (bio)
The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
24 Jan 2024 - Online webinar
This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
Presented by Stuart Angell (bio)
Drug Discovery: A Step-by-Step Introduction
25-26 Jan 2024 - Online webinar
This drug discovery training course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful drug discovery project.
Presented by Peter A. Lowe (bio)
Clinical Quality Management Systems
25-26 Jan 2024 - Online webinar
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
An Essential Overview of Pharmacovigilance
29 Jan 2024 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
MBA Strategic Thinking for Pharma and Biopharma Professionals
29-30 Jan 2024 - Online webinar
Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.
Presented by Laura Brown (bio)
Regulatory Affairs for Support Staff
29-30 Jan 2024 - Online webinar
This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
Presented by Norah Lightowler (bio)
Cyber Security for Medical Devices
30-31 Jan 2024 - Online webinar
This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.
Presented by Ben Kokx (bio)
An Introduction to Pharmaceutical Packaging
30 Jan-1 Feb 2024 - Online webinar
This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.
Presented by Chris Penfold (bio)
Data Integrity Auditor Master Class
30-31 Jan 2024 - Online webinar
During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.
Presented by Mustafa Edik (bio)
Pharmacovigilance
31 Jan-2 Feb 2024 - Online webinar
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
Presented by
Glyn Belcher (bio)
and 4 more leading experts
Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge
31 Jan-2 Feb 2024 - Online webinar
This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.
Presented by Graeme Ladds (bio)
ICH Q9(R1) Quality Risk Management (QRM)
31 Jan 2024 - Online webinar
ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.
Presented by Bruce Davis (bio)
February 2024 training courses
Variations to Marketing Authorisations
1-2 Feb 2024 - Online webinar
A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.
Presented by Marloes van der Geer (bio)
Effective Technical Writing & Editing
1 Feb 2024 - Online webinar
Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.
Presented by Barbara Grossman (bio)
Advanced Regulatory Affairs for Medical Devices
1-2 Feb 2024 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Navigating China’s API Regulations: An Essential Guide to DMF Registration
1 Feb 2024 - Online webinar
Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.
Sterilization of Medical Devices
1-2 Feb 2024 - Online webinar
Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
Presented by Annette Callaghan (bio)
Risk Management for Pharma and Biopharma Professionals
2 Feb 2024 - Online webinar
This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.
Presented by Laura Brown (bio)
Cosmetovigilance
5-6 Feb 2024 - Online webinar
This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW).
It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.
Presented by Graeme Ladds (bio)
Pharmaceutical Development of ATMPs
5-8 Feb 2024 - Online webinar
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
Introduction to Veterinary Pharmacovigilance
5-8 Feb 2024 - Online webinar
A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.
*INCLUDES: Interactive workshop and discussion sessions*
Presented by Declan O'Rourke (bio)
Medical Device Regulations in the Middle East and North Africa
5-6 Feb 2024 - Online webinar
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.
Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen
Delivery of Biologics to the Nasal Cavity
6 Feb 2024 - Online webinar
The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.
Presented by
Irene Rossi (bio)
and 3 more leading experts
An Introduction to the Medical Device Regulation
6-8 Feb 2024 - Online webinar
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
The FDA Drug Approval Process
6-7 Feb 2024 - Online webinar
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
The Pharma Mini MBA
7-9 Feb 2024 - Online webinar
A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
7-8 Feb 2024 - Online webinar
This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)
Presented by John Price (bio)
Process Validation for Medical Devices
7-8 Feb 2024 - Online webinar
This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.
Presented by Stuart Angell (bio)
The Role of Wellbeing in Individual and Organisational Growth
8 Feb 2024 - Online webinar
This programme will discuss definitions of wellbeing, acknowledging that it has many different components. It will detail what each of these components are and the need to understand the symbiotic significance of each component. Drawing on neurological evidence the programme will examine the signs of declining Well Being, and explain the related negative outcomes to the individual and the workplace.
Presented by Claire Mould (bio)
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
8-9 Feb 2024 - Online webinar
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Presented by Anna Harrington-Morozova (bio)
EU Pharmaceutical Regulations & Strategy
12-13 Feb 2024 - Online webinar
The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.
Presented by Norah Lightowler (bio)
Development of Combination Products: Critical Interactions
12-13 Feb 2024 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
Working with Emotional Intelligence in the Pharmaceutical and Biopharma Industry
12 Feb 2024 - Online webinar
This emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries.
"What really matters for success, character, happiness and life long achievements is a definite set of emotional skills – your EQ — not just purely cognitive abilities that are measured by IQ tests.” — Daniel Goleman
Presented by Laura Brown (bio)
How to Improve Accuracy and Attention to Detail
13 Feb 2024 - Online webinar
Understand the importance of accuracy and attention to detail in day-to-day work and overcome the distractions of home working
Presented by Laura Brown (bio)
Practical Requirements of the Arab Pharmacovigilance Guidelines
13-14 Feb 2024 - Online webinar
Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East
Presented by Graeme Ladds (bio)
Understanding and Improving Business Processes
13 Feb 2024 - Online webinar
This highly focussed course will give you the knowledge and skills to evaluate and optimise your organisations strategies for understanding and improving business processes.
Presented by Helene Russell (bio)
Drug/Device and Device/Drug Combinations in the EU and USA
14-15 Feb 2024 - Online webinar
Practical guidance on borderline Issues and combination products
Robotics and Digitalization in Aseptic Pharmaceutical Manufacturing
14 Feb 2024 - Online webinar
This free webinar will provide an essential overview of robotics and digitalization in aseptic pharmaceutical manufacturing.
Presented by Daniel Sturm (bio)
Post-Market Surveillance - Practical Application for Medical Devices and IVDs
14 Feb 2024 - Online webinar
Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.
This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities.
Dealing With Difficult People
15 Feb 2024 - Online webinar
During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.
This is an interactive online course consisting of 2 x 90 minute modules.
Presented by Geoff Marsh (bio)
Regulatory Strategies for Orphan Drugs
15 Feb 2024 - Online webinar
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer (bio)
EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience
15-16 Feb 2024 - Online webinar
This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.
Presented by Laura Brown (bio)
How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace
15 Feb 2024 - Online webinar
Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.
Presented by Toni Trevett (bio)
Planning and Implementing a Health & Safety Policy
15 Feb 2024 - Online webinar
Every company needs to have a health & safety policy in place. If this is your area of responsibility, this webinar will give you the knowledge to put a policy together and to put it into practice.
Presented by Andy Farrall (bio)
The Patent Administrator
16 Feb 2024 - Online webinar
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
Clinical Research - A Different Approach to Successful Project Delivery
16 Feb 2024 - Online webinar
This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.
Presented by Roger Joby (bio)
Successfully Conducting Oral Proceedings at the EPO
21 Feb 2024 - Online webinar
Oral proceedings are organised to conclude the majority of appeal cases, and in many opposition and examination cases. Consequently, a European patent attorney will almost certainly at some point have to attend oral proceedings, either to defend a client's invention or to attack a patent held by a competitor. To defend your client's interests correctly and competently it is vital to know what to expect at those occasions and to be property prepared for it.
Presented by Joeri Beetz (bio)
Facilities Management for Office Managers
22 Feb 2024 - Online webinar
An essential course for those responsible for facilities management within their business
Presented by Jodie Read (bio)
US Patent Practice
26-29 Feb 2024 - Online webinar
What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office
Employment Law in Practice from Recruitment to Termination
26-29 Feb 2024 - Online webinar
Raise your knowledge of the latest employment law along with significant case law and learn how to deal practically with the numerous issues an employer regularly faces.
Presented by Toni Trevett (bio)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
26-29 Feb 2024 - Online webinar
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Presented by Janette Benaddi (bio)
Formal Requirements of the European Patent System
26-27 Feb 2024 - Online webinar
A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.
*INCLUDES: Practical and interactive exercises*
Presented by Richard Gillespie (bio)
Metered Dose Inhaler (MDI) Technology
26-29 Feb 2024 - Online webinar
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
Clinical Research Project Management
26-28 Feb 2024 - Online webinar
The leading clinical research project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
Presented by Laura Brown (bio)
Compassionate Leadership and Successful, Sustainable Organisational Growth
27 Feb 2024 - Online webinar
This programme will explain the direct link between compassionate leadership and successful, sustainable organisational growth. The session will detail the key components of compassionate leadership and how this can be achieved in practice.
Presented by Claire Mould (bio)
Pharmaceutical Regulatory Affairs in Asia
27-29 Feb 2024 - Online webinar
This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan
Clean Communication
27 Feb 2024 - Online webinar
Throughout this programme you will learn how to use clean communication to convey your meaning and enhance your relationships, explore how to build rapport with others and understand how to clarify what others want of you. You'll acquire tips and hints for motivating others and practise your use of language to inspire action in others.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Building Self-Belief & Resilience
27 Feb 2024 - Online webinar
This interactive course, designed for those working in HR and will focus on what individuals can do to build and maintain their resilience. We will look at patterns, default behaviour, emotional reactions, and expectations, and offer practical do-able tools and techniques that will help you build resilience for yourself and others in your team
Presented by Nicole Eisele (bio)
Conflict Management & Resolution for HR Professionals
29 Feb 2024 - Online webinar
This interactive course will help you to develop key conflict resolution skills as an important HR conflict management tool to empower and support your staff to manage conflict effectively.
Presented by Nicole Eisele (bio)
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
29 Feb-1 Mar 2024 - Online webinar
The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.
This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.
Presented by Andrew Willis (bio)
Effective Training Skills in the Pharma Industry
29 Feb-1 Mar 2024 - Online webinar
This interactive training skills and processes in pharma course is ideal for anyone with responsibility for planning or delivering training in the pharma, device or animal health industries (includes face-to-face and virtual training).
Presented by Laura Brown (bio)
March 2024 training courses
Pharmacovigilance Aspects of Licensing Agreements
1 Mar 2024 - Online webinar
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
An Essential Overview of the Medical Device Industry
1 Mar 2024 - Online webinar
This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.
UK Conformity Assessed (UKCA) Marking for Medical Devices
1 Mar 2024 - Online webinar
With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.
Presented by Janette Benaddi (bio)
Drafting International Intellectual Property Agreements
4-5 Mar 2024 - Online webinar
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
Veterinary Pharmaceutical Submissions in the EU
4-5 Mar 2024 - Online webinar
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, critical expert reports and regulatory submissions.
Stability Testing of Pharmaceuticals and Biopharmaceuticals
4-7 Mar 2024 - Online webinar
Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
Presented by Paul Palmer (bio)
FDA Approval Process for Medical Devices
4-7 Mar 2024 - Online webinar
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.
Presented by Jonathan Hughes (bio)
European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications
4-8 Mar 2024 - Online webinar
This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.
Presented by Graeme Ladds (bio)
Biosimilars
5-6 Mar 2024 - Online webinar
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Managing the Intergenerational Workplace
5 Mar 2024 - Online webinar
This interactive webinar will look at what Leaders and Managers can do to manage a blended workforce spanning four generations, that vary in their work ethics, ideas about work-life balance and long-term career goals. Practical tips will be discussed on managing intergenerational issues and how to prepare a strategy for increasing levels of inclusivity and respect with your own teams and individual team members.
Presented by Geoff Marsh (bio)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
5-6 Mar 2024 - Online webinar
Applying HF and usability to comply with the MDR.
This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.
Presented by Richard Featherstone (bio)
Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations
6 Mar 2024 - Online webinar
Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.
Presented by Richard Brady (bio)
Masterclass: Artificial Intelligence-based Medical Devices
6 Mar 2024 - Online webinar
Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust and to ensure data is portable and qualitative. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.
Presented by Koen Cobbaert (bio)
Metrics and Earned Value in Clinical Research Projects
6 Mar 2024 - Online webinar
This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.
Presented by Roger Joby (bio)
Building and Managing a Patent Portfolio to Best Support your Business
6 Mar 2024 - Online webinar
A comprehensive one-day course that takes you through the IP commercialisation process to understand how to make the most of IP within your business.
Presented by Olivier Corticchiato (bio)
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
6 Mar 2024 - Online webinar
This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.
Presented by Stuart Angell (bio)
In the Light of Annex 1: Use of Barrier Systems for Aseptic Pharmaceutical Manufacturing
6 Mar 2024 - Online webinar
This free webinar will familiarise attendees with Restricted Access Barrier System (RABS) technologies. An excellent opportunity to receive detailed information about barrier systems with a main focus on isolator technology, particularly since the implementation of EU GMP Annex 1.
Presented by Lukas Munzinger (bio)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
7-8 Mar 2024 - Online webinar
This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.
Pharmaceutical Regulatory Affairs in Africa
7-8 Mar 2024 - Online webinar
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Agile Leadership for Pharma and Biopharma Professionals in a hybrid world
7-8 Mar 2024 - Online webinar
This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results
Presented by Laura Brown (bio)
IP Due Diligence & Freedom to Operate in Practice
7-8 Mar 2024 - Online webinar
This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.
Key Updates for Senior Trade Mark & Design Administrators
7-8 Mar 2024 - Online webinar
This annual update, specifically designed for senior trade mark and design administrators, includes the latest updates from WIPO with discussion on the Madrid and Hague systems and a review of the differences between US, EU and UK practice and what to do about them.
Presented by
JoAnna Emery (bio)
and 3 more leading experts
Essential Skills for Writing Successful Business Cases
7 Mar 2024 - Online webinar
This masterclass will give you the skills and understanding to write clear, compelling and factual documents to give your business initiatives the best chance of success.
Presented by Helene Russell (bio)
IP and Commercialisation: Creating and Maintaining your IP Portfolio
7 Mar 2024 - Online webinar
A practical course focussing on the internal and external considerations of using IP within your business strategy.
Presented by Jane List (bio)
Understanding the European Unitary Patent and Unified Patent Court (UPC)
8 Mar 2024 - Online webinar
The European Patent landscape is set to change radically in June 2023 with the Unitary Patent and Unified Patent Court coming into force. This intensive one-day course will give you essential insights into unitary patents, the UPC and how the new patent system will impact your business.
Presented by Olivier Corticchiato (bio)
Establishing and Nurturing Emotionally Intelligent Teams and Workplaces
11 Mar 2024 - Online webinar
This programme will discuss what an emotionally intelligent team is, and how this differs from a team that is just functioning (and definitely an underperforming or dysfunctional team). It will outline how establishing and nurturing an emotionally intelligent team will enhance the productivity and effectiveness of the team, and therefore the organisation as a whole.
Presented by Claire Mould (bio)
Developing High Performance HR Business Partner and Consulting Skills
11-12 Mar 2024 - Online webinar
Achieve excellence as an HR business partner and enhance your ability to deliver a positive impact and support across the whole business.
Presented by Katie Botten (bio)
Biological Evaluation of Medical Devices
11-12 Mar 2024 - London
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
*Includes:* Interactive workshops and discussion sessions
Project Management for Pharma Professionals
11-12 Mar 2024 - Online webinar
The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
Includes: Interactive workshop sessions
Presented by Laura Brown (bio)
Patent Protection for Software-Related Inventions in Europe and the USA
11-12 Mar 2024 - Online webinar
An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
11-12 Mar 2024 - Online webinar
This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.
Presented by Mel Munro (bio)
The Art of European Claim Drafting
12-13 Mar 2024 - Online webinar
This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.
The Common Technical Document
12-13 Mar 2024 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
New EU GMP Annex 1: Compliant Aseptic Operations
12-14 Mar 2024 - Online webinar
Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety.
During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.
Presented by Mustafa Edik (bio)
Medical Writing for Medical Devices
13-14 Mar 2024 - Online webinar
How to produce quality regulatory documents including the clinical evaluation report (CER)
Understanding Active Pharmaceutical Ingredients (APIs)
13-14 Mar 2024 - Online webinar
This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.
Presented by Paul Palmer (bio)
Smart Packaging and Electronic Patient Information
14 Mar 2024 - Online webinar
Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.
Presented by Graham Howieson (bio)
The Common Technical Document (CTD) Submission in the MENA Region
14 Mar 2024 - Online webinar
This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.
Presented by Mohammad Fat'hy Elnadi (bio)
The Trade Mark Administrator
15 Mar 2024 - Online webinar
This trade mark administrator training course is a comprehensive overview of what every trade mark administrator should know.
Presented by Victoria Silk (bio)
An Essential Overview of Medical Information
15 Mar 2024 - Online webinar
In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring
Presented by Graeme Ladds (bio)
GCP and Clinical Research Update - Hot Inspection Topics
15 Mar 2024 - Online webinar
This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.
Presented by Laura Brown (bio)
Medical Device Studies: Clinical Evidence
18-21 Mar 2024 - Online webinar
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Presented by Janette Benaddi (bio)
Positive Persuading and Influencing Skills for Pharma Professionals
18-19 Mar 2024 - Online webinar
This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business
Presented by Robert Hersowitz (bio)
Signal Detection and Regulatory Expectations
18-19 Mar 2024 - Online webinar
This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
Presented by Graeme Ladds (bio)
Effective Defence of EPO Patent Applications
18 Mar 2024 - Online webinar
Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem-solution approach, giving delegates an edge over other parties.
*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*
Presented by Daniel X Thomas (bio)
A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
18 Mar 2024 - Online webinar
Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU. Regulations for CMC of veterinary pharmaceuticals are complex and are regularly updated, making pharmaceutical product development challenging. This course is designed to guide you through the essential steps in development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorisation applications.
US FDA - Understanding Key Factors When Working with the FDA
19 Mar 2024 - Online webinar
This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration). For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.
Presented by Andrew Willis (bio)
Practical Implementation of GCP in Veterinary Field Studies
19-20 Mar 2024 - Online webinar
This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.
Understanding Computer System Validation (CSV)
19-20 Mar 2024 - Online webinar
This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.
Presented by Paul Palmer (bio)
An Introduction to ISO 22716 - GMP for Cosmetic Products
19-20 Mar 2024 - Online webinar
This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.
Presented by Mustafa Edik (bio)
Advanced Drafting Techniques for Successful EPO Patent Applications
19 Mar 2024 - Online webinar
Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.
*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*
Presented by Daniel X Thomas (bio)
Advanced Pharmacovigilance
20-22 Mar 2024 - Online webinar
This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.
Presented by Graeme Ladds (bio)
Strategic IP Planning
20-22 Mar 2024 - Online webinar
A step-by-step practical guide to strategic IP planning
Presented by Arnaud Gasnier (bio)
Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration
20 Mar 2024 - Online webinar
An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.
Presented by John E. Harrison (bio)
Successful Medical Writing – from Protocol to CTD
20-22 Mar 2024 - Online webinar
Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.
Ensuring Sustainability and Growth by Placing People at the Centre of the Triangulation of Policy, Process & Practice
21 Mar 2024 - Online webinar
This programme will provide a clear understanding of the independent yet interdependent nature of Policy, Processes, and Practice. Focusing on the importance of putting people at the centre of this triangulation.
Presented by Claire Mould (bio)
Pre-Filled Syringes: End-to-End Processing
21-22 Mar 2024 - Online webinar
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Presented by
Dale Charlton (bio)
and 3 more leading experts
Root Cause Analysis and Critical Thinking
22 Mar 2024 - Online webinar
This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals
Presented by Laura Brown (bio)
Medical Device Single Audit Programme (MDSAP)
25-26 Mar 2024 - Online webinar
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
Presented by Stuart Angell (bio)
April 2024 training courses
Data Integrity and Document Management
12 Apr 2024 - Online webinar
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.
Presented by Laura Brown (bio)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
16-19 Apr 2024 - Online webinar
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Presented by Anna Harrington-Morozova (bio)
Advanced Veterinary Pharmacovigilance
16-17 Apr 2024 - Online webinar
Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit
Presented by Declan O'Rourke (bio)
A Practical Guide to Writing Risk Management Plans (RMPs)
16 Apr 2024 - Online webinar
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
Effective Technology Transfer
16-17 Apr 2024 - London
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
Managing Vendor/CRO/CMO Oversight
18-19 Apr 2024 - Online webinar
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
The Role and Skills of a Valuable HR Assistant
19 Apr 2024 - Online webinar
Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .
Presented by Jocelyn Hughes (bio)
CAPA (Corrective and Preventative Action)
22 Apr 2024 - Online webinar
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement, and planning and implementation in process improvements and CAPA.
Presented by Laura Brown (bio)
Freedom-to-Operate Searching
22 Apr 2024 - Online webinar
Get to grips with the fundamentals of FTO searching, understand the scope of a search and analyse the types of rights you will encounter.
Presented by Stephen Adams (bio)
Pharmaceutical Regulatory Affairs in the Middle East
22-23 Apr 2024 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
An Introduction to the Design and Development of Medical Devices
22-23 Apr 2024 - Online webinar
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by David Howlett (bio)
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
22-25 Apr 2024 - London
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Understanding Pharmacovigilance Regulations in APAC
23-24 Apr 2024 - Online webinar
Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.
Presented by
Param Dayal (bio)
and 4 more leading experts
Best Practice for Writing Effective SOPs
23 Apr 2024 - Online webinar
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Patentability
23-24 Apr 2024 - Online webinar
A comprehensive and practical seminar covering the key aspects of patentability searching
Presented by Stephen Adams (bio)
Biotechnology for the Non-Biotechnologist
24-26 Apr 2024 - London
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Robert Alvarez (bio)
and 6 more leading experts
A Practical Guide to Producing and Maintaining the PSMF
24 Apr 2024 - Online webinar
This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.
Presented by Graeme Ladds (bio)
An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
24 Apr 2024 - Online webinar
This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.
Presented by Greg Thay (bio)
Organisational Storytelling for Successful Business Leaders
24 Apr 2024 - Online webinar
A two-part deep dive into the benefits of storytelling for your organisation. Develop your skills to deliver engaging presentations to connect with people in an impactful way.
Presented by Helene Russell (bio)
Filing eCTD Submissions
25 Apr 2024 - Online webinar
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
An Introduction to Health & Safety - how to identify and avoid safety management icebergs
25 Apr 2024 - Online webinar
An essential guide for directors, managers, and all those with health & safety responsibilities within a business.
Presented by Andy Farrall (bio)
State of the Art Searching
25-26 Apr 2024 - Online webinar
Learn when and how to perform a ‘state of the art’ patent search.
Presented by Jane List (bio)
MBA Strategic Thinking for Pharma and Biopharma Professionals
25-26 Apr 2024 - Online webinar
Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.
Presented by Laura Brown (bio)
Sustainable Design and Manufacture for Medical Devices
25 Apr 2024 - London
Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.
Presented by Cormac O'Prey (bio)
Workplace Accident Management and Investigation - from emergency planning to the final report
26 Apr 2024 - Online webinar
This masterclass will equip you with the skills and knowledge required to successfully manage an accident scene and undertake accident investigations in a workplace environment.
Presented by Andy Farrall (bio)
Clinical Trial Monitoring
29-30 Apr 2024 - Online webinar
This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.
Presented by Laura Brown (bio)
Pharmaceutical Regulatory Affairs in China
29-30 Apr 2024 - Online webinar
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
The Role of an Effective HR Advisor
29-30 Apr 2024 - Online webinar
This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.
Presented by Jocelyn Hughes (bio)
Data Integrity Auditor Master Class
30 Apr-1 May 2024 - Online webinar
During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.
Presented by Mustafa Edik (bio)
May 2024 training courses
Registration of Veterinary Vaccines in the USA and Canada
1-2 May 2024 - Online webinar
This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.
Presented by Nick Wills (bio)
Facilities Management for Office Managers
1 May 2024 - Online webinar
An essential course for those responsible for facilities management within their business
Presented by Jodie Read (bio)
Managing Competence within the Medical Device Industry
1 May 2024 - Online webinar
This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.
Presented by Anne Jury (bio)
ICH Q9(R1) Quality Risk Management (QRM)
1 May 2024 - Online webinar
ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.
Presented by Bruce Davis (bio)
An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
1 May 2024 - Online webinar
Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.
Presented by Annette Callaghan (bio)
Cyber Security for Medical Devices
2-3 May 2024 - Online webinar
This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.
Presented by Ben Kokx (bio)
Clinical Trial Regulatory Requirements
2-3 May 2024 - Online webinar
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation one year on and a brief review of key FDA requirements.
Presented by Laura Brown (bio)
Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge
8-10 May 2024 - Online webinar
This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.
Presented by Graeme Ladds (bio)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
9-10 May 2024 - Online webinar
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Presented by Janette Benaddi (bio)
Drug Discovery: A Step-by-Step Introduction
9-10 May 2024 - Online webinar
This drug discovery training course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful drug discovery project.
Presented by Peter A. Lowe (bio)
The Role of the Senior HR Manager
9-10 May 2024 - Online webinar
This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.
Presented by Jocelyn Hughes (bio)
An Essential Overview of the Pharmaceutical and Biotech Industries
10 May 2024 - Online webinar
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
Presented by Laura Brown (bio)
Formal Requirements of the European Patent System
13-14 May 2024 - Online webinar
A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.
*INCLUDES: Practical and interactive exercises*
Presented by Richard Gillespie (bio)
Regulatory Affairs for Support Staff
13-14 May 2024 - London
This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
Presented by Norah Lightowler (bio)
Planning and Implementing a Health & Safety Policy
13 May 2024 - Online webinar
Every company needs to have a health & safety policy in place. If this is your area of responsibility, this webinar will give you the knowledge to put a policy together and to put it into practice.
Presented by Andy Farrall (bio)
Consultative Selling for Pharma Professionals
13-14 May 2024 - Online webinar
In this two-day, selling for pharma professionals training course, Robert Hersowitz leads participants through a four step process guaranteed to foster influence and encourage commitment from clients.
Presented by Robert Hersowitz (bio)
Drafting Effective Pharmaceutical Patents
13-16 May 2024 - Online webinar
Drafting successful pharmaceutical patents is complex and there are many pitfalls and risks to be aware of. You need to ensure you’re maximising the protection for your, and your client’s, pharmaceutical inventions thorough both primary and secondary pharmaceutical patents.
Presented by Amanda Murphy (bio)
The Patent Administrator
14 May 2024 - Online webinar
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
Litigation-Proofing and Proving your Patent Claims
14 May 2024 - London
This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.
Artificial Intelligence and Machine Learning Powered Signal Management
15 May 2024 - Online webinar
This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.
Presented by Sanjeev Srivastav (bio)
An Introduction to the Medical Device Regulation
15-17 May 2024 - Online webinar
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
The Pharma Mini MBA
15-17 May 2024 - Online webinar
A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries
How to Avoid Common Pitfalls in Combined EU/US Patent Applications
15-16 May 2024 - London
This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.
IP and Commercialisation: Creating and Maintaining your IP Portfolio
15 May 2024 - Online webinar
A practical course focussing on the internal and external considerations of using IP within your business strategy.
Presented by Jane List (bio)
An Essential Overview of Pharmacovigilance
16 May 2024 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
Understanding and Improving Business Processes
16 May 2024 - Online webinar
This highly focussed course will give you the knowledge and skills to evaluate and optimise your organisations strategies for understanding and improving business processes.
Presented by Helene Russell (bio)
Presenting Virtually
17 May 2024 - Online webinar
During this seminar you will learn how to prepare and construct a virtual presentation. You will explore the visual supports available, understand how to use the camera and other tools effectively and acquire tips and hints in terms of dealing with technical issues.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Pharmacovigilance QMS & Inspection Preparation
20-21 May 2024 - Online webinar
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience
20-21 May 2024 - Online webinar
This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.
Presented by Laura Brown (bio)
An Introduction to Pharmaceutical Packaging
20-22 May 2024 - Online webinar
This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.
Presented by Chris Penfold (bio)
Managing Remote Teams
20 May 2024 - Online webinar
During this programme you will learn how to adapt your management style for remote team working. You will explore ways to communicate and better understand how to monitor and evaluate your team as well as explore the recruitment implications of managing a remote team.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
21-22 May 2024 - Online webinar
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Presented by Janette Benaddi (bio)
Process Validation with Qualification
21-22 May 2024 - Online webinar
Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.
Presented by Bruce Davis (bio)
The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
21 May 2024 - London
This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
Presented by Stuart Angell (bio)
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
21 May 2024 - Online webinar
Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.
Presented by Annette Callaghan (bio)
EU Proposed Pharmaceutical Legislation Changes
22 May 2024 - Online webinar
On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation.
This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.
Presented by Norah Lightowler (bio)
Clinical Quality Management Systems
23-24 May 2024 - Online webinar
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
June 2024 training courses
The Trade Mark Administrator
3 Jun 2024 - Online webinar
This trade mark administrator training course is a comprehensive overview of what every trade mark administrator should know.
Presented by Victoria Silk (bio)
IP Due Diligence & Freedom to Operate in Practice
4 Jun 2024 - London
This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.
Advanced Regulatory Affairs for Medical Devices
4-7 Jun 2024 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Variations to Marketing Authorisations
4-5 Jun 2024 - Online webinar
A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.
Presented by Marloes van der Geer (bio)
Delivery of Biologics to the Nasal Cavity
4 Jun 2024 - Online webinar
The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.
Presented by
Irene Rossi (bio)
and 3 more leading experts
Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
4 Jun 2024 - Online webinar
The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.
Presented by Annette Callaghan (bio)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
5-6 Jun 2024 - London
Applying HF and usability to comply with the MDR.
This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.
Presented by Richard Featherstone (bio)
Advanced Pharmacovigilance
5-7 Jun 2024 - London
This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.
Presented by Graeme Ladds (bio)
Patent Protection for Software-Related Inventions in Europe and the USA
5 Jun 2024 - London
An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.
Building and Managing a Patent Portfolio to Best Support your Business
5 Jun 2024 - Online webinar
A comprehensive one-day course that takes you through the IP commercialisation process to understand how to make the most of IP within your business.
Presented by Olivier Corticchiato (bio)
Process Validation for Medical Devices
5-6 Jun 2024 - London
This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.
Presented by Stuart Angell (bio)
Sterilization of Medical Devices
6-7 Jun 2024 - Online webinar
Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
Presented by Annette Callaghan (bio)
Post-Market Surveillance - Practical Application for Medical Devices and IVDs
6 Jun 2024 - Online webinar
Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.
This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities.
Risk Management for Pharma and Biopharma Professionals
7 Jun 2024 - Online webinar
This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.
Presented by Laura Brown (bio)
The Medical Device School - From Concept to CE Marking
10-14 Jun 2024 - London
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.
Presented by
Stuart Angell (bio)
and 7 more leading experts
Employment Law in Practice from Recruitment to Termination
10-11 Jun 2024 - Online webinar
Raise your knowledge of the latest employment law along with significant case law and learn how to deal practically with the numerous issues an employer regularly faces.
Presented by Toni Trevett (bio)
How to Improve Accuracy and Attention to Detail
10 Jun 2024 - Online webinar
Understand the importance of accuracy and attention to detail in day-to-day work and overcome the distractions of home working
Presented by Laura Brown (bio)
Clinical Research - A Different Approach to Successful Project Delivery
10 Jun 2024 - Online webinar
This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.
Presented by Roger Joby (bio)
Successfully Conducting Oral Proceedings at the EPO
10 Jun 2024 - Online webinar
Oral proceedings are organised to conclude the majority of appeal cases, and in many opposition and examination cases. Consequently, a European patent attorney will almost certainly at some point have to attend oral proceedings, either to defend a client's invention or to attack a patent held by a competitor. To defend your client's interests correctly and competently it is vital to know what to expect at those occasions and to be property prepared for it.
Presented by Joeri Beetz (bio)
EU Pharmaceutical Regulations & Strategy
11-12 Jun 2024 - London
The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.
Presented by Norah Lightowler (bio)
Medical Device Regulations in the Middle East and North Africa
11-12 Jun 2024 - Online webinar
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.
Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen
The FDA Drug Approval Process
12-13 Jun 2024 - Online webinar
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Pharmacovigilance
12-14 Jun 2024 - Online webinar
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
Presented by
Glyn Belcher (bio)
and 4 more leading experts
Pharmaceutical Regulatory Affairs in Asia
12-14 Jun 2024 - Online webinar
This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan
Dealing With Difficult People
13 Jun 2024 - Online webinar
During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.
This is an interactive online course consisting of 2 x 90 minute modules.
Presented by Geoff Marsh (bio)
US Patent Practice
13-14 Jun 2024 - London
What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office
Effective Training Skills in the Pharma Industry
13-14 Jun 2024 - Online webinar
This interactive training skills and processes in pharma course is ideal for anyone with responsibility for planning or delivering training in the pharma, device or animal health industries (includes face-to-face and virtual training).
Presented by Laura Brown (bio)
Practical Requirements of the Arab Pharmacovigilance Guidelines
13-14 Jun 2024 - Online webinar
Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East
Presented by Graeme Ladds (bio)
Project Management for Pharma Professionals
17-18 Jun 2024 - London
The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
Includes: Interactive workshop sessions
Presented by Laura Brown (bio)
The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA
17-20 Jun 2024 - London
This practical four-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
Pharmaceutical Development of ATMPs
18-19 Jun 2024 - Online webinar
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
19-20 Jun 2024 - Online webinar
This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)
Presented by John Price (bio)
FDA Approval Process for Medical Devices
19-20 Jun 2024 - Online webinar
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.
Presented by Jonathan Hughes (bio)
Essential Skills for Writing Successful Business Cases
19 Jun 2024 - Online webinar
This masterclass will give you the skills and understanding to write clear, compelling and factual documents to give your business initiatives the best chance of success.
Presented by Helene Russell (bio)
Non-Conformance and Corrective Action for Medical Device Manufacturers
19 Jun 2024 - Online webinar
The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.
Presented by Annette Callaghan (bio)
Metered Dose Inhaler (MDI) Technology
20-21 Jun 2024 - Online webinar
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
Cosmetovigilance
20-21 Jun 2024 - Online webinar
This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW).
It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.
Presented by Graeme Ladds (bio)
Working with Emotional Intelligence in the Pharmaceutical and Biopharma Industry
21 Jun 2024 - Online webinar
This emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries.
"What really matters for success, character, happiness and life long achievements is a definite set of emotional skills – your EQ — not just purely cognitive abilities that are measured by IQ tests.” — Daniel Goleman
Presented by Laura Brown (bio)
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
24-27 Jun 2024 - Online webinar
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Presented by Anna Harrington-Morozova (bio)
Biotechnology for the Non-Biotechnologist
24-28 Jun 2024 - Online webinar
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Robert Alvarez (bio)
and 6 more leading experts
Regulatory Strategies for Orphan Drugs
24 Jun 2024 - Online webinar
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer (bio)
Managing Vendor/CRO/CMO Oversight
24-25 Jun 2024 - Online webinar
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
Development of Combination Products: Critical Interactions
25-26 Jun 2024 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
Understanding the European Unitary Patent and Unified Patent Court (UPC)
25 Jun 2024 - Online webinar
The European Patent landscape is set to change radically in June 2023 with the Unitary Patent and Unified Patent Court coming into force. This intensive one-day course will give you essential insights into unitary patents, the UPC and how the new patent system will impact your business.
Presented by Olivier Corticchiato (bio)
Clinical Research Project Management
26-28 Jun 2024 - Online webinar
The leading clinical research project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
Presented by Laura Brown (bio)
Introduction to Veterinary Pharmacovigilance
27-28 Jun 2024 - Online webinar
A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.
*INCLUDES: Interactive workshop and discussion sessions*
Presented by Declan O'Rourke (bio)
Clean Communication
27 Jun 2024 - Online webinar
Throughout this programme you will learn how to use clean communication to convey your meaning and enhance your relationships, explore how to build rapport with others and understand how to clarify what others want of you. You'll acquire tips and hints for motivating others and practise your use of language to inspire action in others.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
27-28 Jun 2024 - Online webinar
The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.
This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.
Presented by Andrew Willis (bio)
Effective Technical Writing & Editing
28 Jun 2024 - Online webinar
Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.
Presented by Barbara Grossman (bio)
July 2024 training courses
Medical Writing for Medical Devices
1-2 Jul 2024 - Online webinar
How to produce quality regulatory documents including the clinical evaluation report (CER)
Signal Detection and Regulatory Expectations
1-2 Jul 2024 - Online webinar
This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
Presented by Graeme Ladds (bio)
IP Department Roadmap
1 Jul 2024 - Online webinar
This course provides a step-by-step, matrix-based methodology with a top-down and cross-functional approach to design an IP department roadmap
Presented by Arnaud Gasnier (bio)
GCP and Clinical Research Update - Hot Inspection Topics
1 Jul 2024 - Online webinar
This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.
Presented by Laura Brown (bio)
The Common Technical Document
2-3 Jul 2024 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Medical Device Regulation in the Eurasian Union, Russia and the CIS
2-3 Jul 2024 - Online webinar
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Presented by Anna Harrington-Morozova (bio)
Pharmaceutical Regulatory Affairs in China
2-3 Jul 2024 - Online webinar
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
New EU GMP Annex 1: Compliant Aseptic Operations
2-4 Jul 2024 - Online webinar
Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety.
During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.
Presented by Mustafa Edik (bio)
Cyber Security for Medical Devices
4-5 Jul 2024 - London
This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.
Presented by Ben Kokx (bio)
Agile Leadership for Pharma and Biopharma Professionals in a hybrid world
4-5 Jul 2024 - Online webinar
This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results
Presented by Laura Brown (bio)
Sustainable Design and Manufacture for Medical Devices
4 Jul 2024 - Online webinar
Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.
Presented by Cormac O'Prey (bio)
Medical Device Single Audit Programme (MDSAP)
4-5 Jul 2024 - Online webinar
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
Presented by Stuart Angell (bio)
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
4 Jul 2024 - London
This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.
Presented by Stuart Angell (bio)
An Introduction to Health & Safety - how to identify and avoid safety management icebergs
5 Jul 2024 - Online webinar
An essential guide for directors, managers, and all those with health & safety responsibilities within a business.
Presented by Andy Farrall (bio)
An Essential Overview of the Medical Device Industry
8-9 Jul 2024 - Online webinar
This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.
Understanding Pharmacovigilance Regulations in APAC
8-9 Jul 2024 - Online webinar
Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.
Presented by
Param Dayal (bio)
and 4 more leading experts
Workplace Accident Management and Investigation - from emergency planning to the final report
9 Jul 2024 - Online webinar
This masterclass will equip you with the skills and knowledge required to successfully manage an accident scene and undertake accident investigations in a workplace environment.
Presented by Andy Farrall (bio)
Biosimilars
10-11 Jul 2024 - Online webinar
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Pharmacovigilance Aspects of Licensing Agreements
10 Jul 2024 - Online webinar
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Medical Device Studies: Clinical Evidence
10-11 Jul 2024 - Online webinar
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Presented by Janette Benaddi (bio)
Smart Packaging and Electronic Patient Information
10 Jul 2024 - Online webinar
Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.
Presented by Graham Howieson (bio)
The Common Technical Document (CTD) Submission in the MENA Region
10 Jul 2024 - Online webinar
This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.
Presented by Mohammad Fat'hy Elnadi (bio)
An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
10 Jul 2024 - London
This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.
Presented by Greg Thay (bio)
Drafting International Intellectual Property Agreements
11-12 Jul 2024 - Online webinar
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
Clinical Trial Monitoring
11-12 Jul 2024 - Online webinar
This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.
Presented by Laura Brown (bio)
The Art of European Claim Drafting
11-12 Jul 2024 - Online webinar
This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.
Stability Testing of Pharmaceuticals and Biopharmaceuticals
11-12 Jul 2024 - Online webinar
Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
Presented by Paul Palmer (bio)
Metrics and Earned Value in Clinical Research Projects
11 Jul 2024 - Online webinar
This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.
Presented by Roger Joby (bio)
An Essential Overview of Medical Information
11 Jul 2024 - Online webinar
In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring
Presented by Graeme Ladds (bio)
Conflict Management & Resolution for HR Professionals
15 Jul 2024 - London
This interactive course will help you to develop key conflict resolution skills as an important HR conflict management tool to empower and support your staff to manage conflict effectively.
Presented by Nicole Eisele (bio)
European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications
15-17 Jul 2024 - Online webinar
This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.
Presented by Graeme Ladds (bio)
UK Conformity Assessed (UKCA) Marking for Medical Devices
15 Jul 2024 - Online webinar
With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.
Presented by Janette Benaddi (bio)
The 5-day Comprehensive Management Summer School
15-19 Jul 2024 - London
This interactive Summer School has been designed for professionals who want to learn how to deal more positively with situations to achieve greater success by enhancing their leadership skills through adopting a compassionate approach, as well as learning new techniques to manage across the generational spectrum.
Presented by
Nicole Eisele (bio)
and 3 more leading experts
The HR Professional Summer School
15-19 Jul 2024 - London
This interactive Summer School explores some of the most important issues facing HR professionals today and has been designed for those who want to add value to their HR function and be a high-performing member of their senior management team.
Presented by
Katie Botten (bio)
and 5 more leading experts
MBA Strategic Thinking for Pharma and Biopharma Professionals
15-16 Jul 2024 - London
Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.
Presented by Laura Brown (bio)
Effective Technology Transfer
16-17 Jul 2024 - Online webinar
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
The Role of Wellbeing in Individual and Organisational Growth
16 Jul 2024 - London
This programme will discuss definitions of wellbeing, acknowledging that it has many different components. It will detail what each of these components are and the need to understand the symbiotic significance of each component. Drawing on neurological evidence the programme will examine the signs of declining Well Being, and explain the related negative outcomes to the individual and the workplace.
Presented by Claire Mould (bio)
The Leadership and Management Summer School
16-19 Jul 2024 - London
This highly interactive 4-day leadership summer school is designed to give aspiring leaders the opportunity to enhance existing skills, explore current trends and thinking, and ensure sustainability and growth by adopting a compassionate approach to leadership.
Developing High Performance HR Business Partner and Consulting Skills
17-18 Jul 2024 - London
Achieve excellence as an HR business partner and enhance your ability to deliver a positive impact and support across the whole business.
Presented by Katie Botten (bio)
Pharmaceutical Regulatory Affairs in the Middle East
17-18 Jul 2024 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Understanding Active Pharmaceutical Ingredients (APIs)
17-18 Jul 2024 - Online webinar
This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.
Presented by Paul Palmer (bio)
An Introduction to ISO 22716 - GMP for Cosmetic Products
17-18 Jul 2024 - Online webinar
This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.
Presented by Mustafa Edik (bio)
Establishing and Nurturing Emotionally Intelligent Teams and Workplaces
17 Jul 2024 - London
This programme will discuss what an emotionally intelligent team is, and how this differs from a team that is just functioning (and definitely an underperforming or dysfunctional team). It will outline how establishing and nurturing an emotionally intelligent team will enhance the productivity and effectiveness of the team, and therefore the organisation as a whole.
Presented by Claire Mould (bio)
US FDA - Understanding Key Factors When Working with the FDA
18 Jul 2024 - Online webinar
This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration). For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.
Presented by Andrew Willis (bio)
Advanced Veterinary Pharmacovigilance
18-19 Jul 2024 - Online webinar
Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit
Presented by Declan O'Rourke (bio)
Best Practice for Writing Effective SOPs
18 Jul 2024 - Online webinar
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations
18 Jul 2024 - Online webinar
Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.
Presented by Richard Brady (bio)
Ensuring Sustainability and Growth by Placing People at the Centre of the Triangulation of Policy, Process & Practice
18 Jul 2024 - London
This programme will provide a clear understanding of the independent yet interdependent nature of Policy, Processes, and Practice. Focusing on the importance of putting people at the centre of this triangulation.
Presented by Claire Mould (bio)
Managing the Intergenerational Workplace
19 Jul 2024 - London
This interactive webinar will look at what Leaders and Managers can do to manage a blended workforce spanning four generations, that vary in their work ethics, ideas about work-life balance and long-term career goals. Practical tips will be discussed on managing intergenerational issues and how to prepare a strategy for increasing levels of inclusivity and respect with your own teams and individual team members.
Presented by Geoff Marsh (bio)
The Role and Skills of a Valuable HR Assistant
19 Jul 2024 - Online webinar
Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .
Presented by Jocelyn Hughes (bio)
Compassionate Leadership and Successful, Sustainable Organisational Growth
19 Jul 2024 - London
This programme will explain the direct link between compassionate leadership and successful, sustainable organisational growth. The session will detail the key components of compassionate leadership and how this can be achieved in practice.
Presented by Claire Mould (bio)
CAPA (Corrective and Preventative Action)
19 Jul 2024 - Online webinar
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement, and planning and implementation in process improvements and CAPA.
Presented by Laura Brown (bio)
Filing eCTD Submissions
19 Jul 2024 - Online webinar
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
22-25 Jul 2024 - Online webinar
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Data Integrity and Document Management
22 Jul 2024 - Online webinar
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.
Presented by Laura Brown (bio)
Root Cause Analysis and Critical Thinking
23 Jul 2024 - London
This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals
Presented by Laura Brown (bio)
Pharmaceutical Regulatory Affairs in Africa
23-24 Jul 2024 - Online webinar
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Organisational Storytelling for Successful Business Leaders
23 Jul 2024 - Online webinar
A two-part deep dive into the benefits of storytelling for your organisation. Develop your skills to deliver engaging presentations to connect with people in an impactful way.
Presented by Helene Russell (bio)
An Introduction to the Design and Development of Medical Devices
24-25 Jul 2024 - Online webinar
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by David Howlett (bio)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
24-25 Jul 2024 - Online webinar
This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.
Understanding Computer System Validation (CSV)
24-25 Jul 2024 - Online webinar
This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.
Presented by Paul Palmer (bio)
Successful Medical Writing – from Protocol to CTD
24-26 Jul 2024 - Online webinar
Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.
Data Integrity Auditor Master Class
24-25 Jul 2024 - Online webinar
During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.
Presented by Mustafa Edik (bio)
EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience
25-26 Jul 2024 - Online webinar
This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.
Presented by Laura Brown (bio)
Pre-Filled Syringes: End-to-End Processing
25-26 Jul 2024 - Online webinar
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Presented by
Dale Charlton (bio)
and 3 more leading experts
Masterclass: Artificial Intelligence-based Medical Devices
26 Jul 2024 - Online webinar
Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust and to ensure data is portable and qualitative. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.
Presented by Koen Cobbaert (bio)
Positive Persuading and Influencing Skills for Pharma Professionals
29-30 Jul 2024 - Online webinar
This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business
Presented by Robert Hersowitz (bio)
The Role of an Effective HR Advisor
29-30 Jul 2024 - Online webinar
This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.
Presented by Jocelyn Hughes (bio)
The Leadership and Management Summer School for Pharma Professionals
29 Jul-2 Aug 2024 - Online webinar
Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure, is probably one of the most challenging managerial roles of any industry today. This 5-day Summer School has been especially designed to help you transcend these challenges by training you to become equipped to see the bigger picture in all aspects of your role.
Presented by
Leela Barham (bio)
and 3 more leading experts
An Introduction to the Medical Device Regulation
31 Jul-2 Aug 2024 - London
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
The Pharma Mini MBA
31 Jul-2 Aug 2024 - Online webinar
A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries
August 2024 training courses
A Practical Guide to Writing Risk Management Plans (RMPs)
1 Aug 2024 - Online webinar
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
Understanding and Improving Business Processes
1 Aug 2024 - Online webinar
This highly focussed course will give you the knowledge and skills to evaluate and optimise your organisations strategies for understanding and improving business processes.
Presented by Helene Russell (bio)
IP and Commercialisation: Creating and Maintaining your IP Portfolio
1 Aug 2024 - Online webinar
A practical course focussing on the internal and external considerations of using IP within your business strategy.
Presented by Jane List (bio)
A Practical Guide to Producing and Maintaining the PSMF
5 Aug 2024 - Online webinar
This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.
Presented by Graeme Ladds (bio)
Formal Requirements of the European Patent System
5-6 Aug 2024 - London
A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.
*INCLUDES: Practical and interactive exercises*
Presented by Richard Gillespie (bio)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
5-6 Aug 2024 - London
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Presented by Janette Benaddi (bio)
Planning and Implementing a Health & Safety Policy
5 Aug 2024 - Online webinar
Every company needs to have a health & safety policy in place. If this is your area of responsibility, this webinar will give you the knowledge to put a policy together and to put it into practice.
Presented by Andy Farrall (bio)
Facilities Management for Office Managers
6 Aug 2024 - Online webinar
An essential course for those responsible for facilities management within their business
Presented by Jodie Read (bio)
The Patent Administrator
7 Aug 2024 - London
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
September 2024 training courses
An Essential Overview of Pharmacovigilance
9-10 Sep 2024 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
Presenting Virtually
10 Sep 2024 - Online webinar
During this seminar you will learn how to prepare and construct a virtual presentation. You will explore the visual supports available, understand how to use the camera and other tools effectively and acquire tips and hints in terms of dealing with technical issues.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
FDA Approval Process for Medical Devices
10-11 Sep 2024 - London
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.
Presented by Jonathan Hughes (bio)
Managing Remote Teams
11 Sep 2024 - Online webinar
During this programme you will learn how to adapt your management style for remote team working. You will explore ways to communicate and better understand how to monitor and evaluate your team as well as explore the recruitment implications of managing a remote team.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Registration of Veterinary Vaccines in the USA and Canada
11-12 Sep 2024 - Online webinar
This course will cover some of the most complex yet fundamental aspects of veterinary vaccines licensing by USDA and CFIA including the phased submission process as well as the format and content specifications for the required dossier components.
Presented by Nick Wills (bio)
Patent Protection for Software-Related Inventions in Europe and the USA
12-13 Sep 2024 - Online webinar
An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.
An Essential Overview of the Pharmaceutical and Biotech Industries
13 Sep 2024 - Online webinar
This programme will give you an invaluable overview of the pharmaceutical industry, from discovery of the molecule through development to marketing.
Presented by Laura Brown (bio)
Clinical Trial Regulatory Requirements
16-17 Sep 2024 - Online webinar
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation one year on and a brief review of key FDA requirements.
Presented by Laura Brown (bio)
Biological Evaluation of Medical Devices
16-17 Sep 2024 - London
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
*Includes:* Interactive workshops and discussion sessions
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
16-19 Sep 2024 - Online webinar
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Presented by Janette Benaddi (bio)
The Trade Mark Administrator
16 Sep 2024 - Online webinar
This trade mark administrator training course is a comprehensive overview of what every trade mark administrator should know.
Presented by Victoria Silk (bio)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
17-20 Sep 2024 - Online webinar
Applying HF and usability to comply with the MDR.
This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.
Presented by Richard Featherstone (bio)
Consultative Selling for Pharma Professionals
17-18 Sep 2024 - Online webinar
In this two-day, selling for pharma professionals training course, Robert Hersowitz leads participants through a four step process guaranteed to foster influence and encourage commitment from clients.
Presented by Robert Hersowitz (bio)
Advanced Pharmacovigilance
18-20 Sep 2024 - Online webinar
This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.
Presented by Graeme Ladds (bio)
Artificial Intelligence and Machine Learning Powered Signal Management
18 Sep 2024 - London
This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.
Presented by Sanjeev Srivastav (bio)
Strategic IP Planning
18-20 Sep 2024 - Online webinar
A step-by-step practical guide to strategic IP planning
Presented by Arnaud Gasnier (bio)
Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration
18 Sep 2024 - Online webinar
An an excellent opportunity to hear from a renowned cognition expert and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes.
Presented by John E. Harrison (bio)
EU Proposed Pharmaceutical Legislation Changes
18 Sep 2024 - Online webinar
On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation.
This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.
Presented by Norah Lightowler (bio)
Drug Discovery: A Step-by-Step Introduction
19-20 Sep 2024 - Online webinar
This drug discovery training course takes you on a science-based drug discovery journey. You will travel from inception of a new project to the point of hand-over of the newly discovered molecule to the Drug Development Team for pre-clinical and clinical studies. The course breaks down the long, multi-faceted drug discovery process into individual steps which build towards this key goal. The focus is on how essential science, technology and infrastructure elements are constituted, deployed and integrated to maximise the likelihood of a successful drug discovery project.
Presented by Peter A. Lowe (bio)
Clinical Quality Management Systems
19-20 Sep 2024 - Online webinar
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
Key Updates for Senior Trade Mark & Design Administrators
19-20 Sep 2024 - London
This annual update, specifically designed for senior trade mark and design administrators, includes the latest updates from WIPO with discussion on the Madrid and Hague systems and a review of the differences between US, EU and UK practice and what to do about them.
Presented by
JoAnna Emery (bio)
and 3 more leading experts
Understanding the European Unitary Patent and Unified Patent Court (UPC)
20 Sep 2024 - London
The European Patent landscape is set to change radically in June 2023 with the Unitary Patent and Unified Patent Court coming into force. This intensive one-day course will give you essential insights into unitary patents, the UPC and how the new patent system will impact your business.
Presented by Olivier Corticchiato (bio)
IP Due Diligence & Freedom to Operate in Practice
23-24 Sep 2024 - Online webinar
This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.
Process Validation with Qualification
23-24 Sep 2024 - London
Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.
Presented by Bruce Davis (bio)
Effective Defence of EPO Patent Applications
23 Sep 2024 - Online webinar
Clarity in drafting patent applications has always been a serious issue. The purpose of the seminar is to teach delegates the essentials of clarity, and the most effective use of the problem-solution approach, giving delegates an edge over other parties.
*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*
Presented by Daniel X Thomas (bio)
Regulatory Affairs for Support Staff
24-25 Sep 2024 - Online webinar
This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.
Presented by Norah Lightowler (bio)
Advanced Drafting Techniques for Successful EPO Patent Applications
24 Sep 2024 - Online webinar
Many patent applications and patents are lost before the EPO, either before Opposition Divisions or before Appeal due to incorrect original drafting, and added subject matter is a recurrent problem. Learn advanced drafting techniques for successful EPO patent applications.
*INCLUDES: Interactive workshop sessions and details of the latest case law and its implications*
Presented by Daniel X Thomas (bio)
The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
24 Sep 2024 - Online webinar
This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
Presented by Stuart Angell (bio)
An Introduction to Pharmaceutical Packaging
25-27 Sep 2024 - London
This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.
Presented by Chris Penfold (bio)
Biotechnology for the Non-Biotechnologist
25-27 Sep 2024 - London
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Robert Alvarez (bio)
and 6 more leading experts
ICH Q9(R1) Quality Risk Management (QRM)
25 Sep 2024 - Online webinar
ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.
Presented by Bruce Davis (bio)
Project Management for Pharma Professionals
26-27 Sep 2024 - Online webinar
The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
Includes: Interactive workshop sessions
Presented by Laura Brown (bio)
Pharmacovigilance QMS & Inspection Preparation
26-27 Sep 2024 - Online webinar
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
Essential Skills for Writing Successful Business Cases
26 Sep 2024 - Online webinar
This masterclass will give you the skills and understanding to write clear, compelling and factual documents to give your business initiatives the best chance of success.
Presented by Helene Russell (bio)
Building and Managing a Patent Portfolio to Best Support your Business
27 Sep 2024 - Online webinar
A comprehensive one-day course that takes you through the IP commercialisation process to understand how to make the most of IP within your business.
Presented by Olivier Corticchiato (bio)
Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge
30 Sep-2 Oct 2024 - Online webinar
This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.
Presented by Graeme Ladds (bio)
October 2024 training courses
Effective Technical Writing & Editing
1 Oct 2024 - Online webinar
Expert advice on how to write and edit scientific and medical texts, technical documents and those documents needed for regulatory submission.
Presented by Barbara Grossman (bio)
Biosimilars
1-2 Oct 2024 - Online webinar
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Introduction to Veterinary Pharmacovigilance
2-3 Oct 2024 - Online webinar
A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance.
*INCLUDES: Interactive workshop and discussion sessions*
Presented by Declan O'Rourke (bio)
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
2-3 Oct 2024 - Online webinar
This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD)
Presented by John Price (bio)
MBA Strategic Thinking for Pharma and Biopharma Professionals
3-4 Oct 2024 - Online webinar
Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure including the impact of COVID-19, is probably one of the most challenging managerial roles of any industry today.
Presented by Laura Brown (bio)
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
3-4 Oct 2024 - Online webinar
This interactive course will discuss the regulatory requirements within these regions, and discuss the implications of the new joint Eurasian Union regulation.
Presented by Anna Harrington-Morozova (bio)
Sustainable Design and Manufacture for Medical Devices
4 Oct 2024 - London
Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.
Presented by Cormac O'Prey (bio)
An Introduction to Health & Safety - how to identify and avoid safety management icebergs
4 Oct 2024 - Online webinar
An essential guide for directors, managers, and all those with health & safety responsibilities within a business.
Presented by Andy Farrall (bio)
Clinical Research - A Different Approach to Successful Project Delivery
4 Oct 2024 - Online webinar
This Clinical Research Project Management Training course will provide you with key techniques to apply during your clinical research project to aid successful project delivery. This course will be key for those involved in clinical research projects and will cover system thinking, agile approaches and risk analysis.
Presented by Roger Joby (bio)
Building Self-Belief & Resilience
7 Oct 2024 - Online webinar
This interactive course, designed for those working in HR and will focus on what individuals can do to build and maintain their resilience. We will look at patterns, default behaviour, emotional reactions, and expectations, and offer practical do-able tools and techniques that will help you build resilience for yourself and others in your team
Presented by Nicole Eisele (bio)
Effective Technology Transfer
7-8 Oct 2024 - London
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
Development of Combination Products: Critical Interactions
7-10 Oct 2024 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
How to Improve Accuracy and Attention to Detail
7 Oct 2024 - Online webinar
Understand the importance of accuracy and attention to detail in day-to-day work and overcome the distractions of home working
Presented by Laura Brown (bio)
Medical Device Regulations in the Middle East and North Africa
7-8 Oct 2024 - Online webinar
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.
Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen
Advanced Regulatory Affairs for Medical Devices
7-8 Oct 2024 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Organisational Storytelling for Successful Business Leaders
7 Oct 2024 - Online webinar
A two-part deep dive into the benefits of storytelling for your organisation. Develop your skills to deliver engaging presentations to connect with people in an impactful way.
Presented by Helene Russell (bio)
Conflict Management & Resolution for HR Professionals
8-9 Oct 2024 - Online webinar
This interactive course will help you to develop key conflict resolution skills as an important HR conflict management tool to empower and support your staff to manage conflict effectively.
Presented by Nicole Eisele (bio)
Regulatory Strategies for Orphan Drugs
8 Oct 2024 - Online webinar
This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer (bio)
Risk Management for Pharma and Biopharma Professionals
8 Oct 2024 - Online webinar
This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.
Presented by Laura Brown (bio)
US Patent Practice
8-11 Oct 2024 - Online webinar
What all European patent attorneys need to know - an intensive and highly interactive two-day seminar including discussions on US patent law and strategies and tactics for patent prosecution at the US Patent Office
Delivery of Biologics to the Nasal Cavity
8 Oct 2024 - Online webinar
The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.
Presented by
Irene Rossi (bio)
and 3 more leading experts
Understanding Pharmacovigilance Regulations in APAC
8-9 Oct 2024 - Online webinar
Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.
Presented by
Param Dayal (bio)
and 4 more leading experts
Metered Dose Inhaler (MDI) Technology
9-10 Oct 2024 - Online webinar
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
A Practical Guide to Writing Risk Management Plans (RMPs)
9 Oct 2024 - Online webinar
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
Pharmaceutical Regulatory Affairs in Asia
9-11 Oct 2024 - Online webinar
This seminar will provide an overview of the key areas of pharmaceutical regulatory affairs in Asia including, China, Hong Kong SAR, Brunei, the Philippines, India, Indonesia, Malaysia, Singapore, Thailand, Cambodia, Laos, Vietnam, Taiwan, Korea, Japan
Employment Law in Practice from Recruitment to Termination
9-10 Oct 2024 - Online webinar
Raise your knowledge of the latest employment law along with significant case law and learn how to deal practically with the numerous issues an employer regularly faces.
Presented by Toni Trevett (bio)
Pharmacovigilance
9-11 Oct 2024 - Online webinar
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
Presented by
Glyn Belcher (bio)
and 4 more leading experts
A Practical Guide to Producing and Maintaining the PSMF
10 Oct 2024 - Online webinar
This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.
Presented by Graeme Ladds (bio)
Variations to Marketing Authorisations
10-11 Oct 2024 - Online webinar
A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.
Presented by Marloes van der Geer (bio)
State of the Art Searching
10-11 Oct 2024 - Online webinar
Learn when and how to perform a ‘state of the art’ patent search.
Presented by Jane List (bio)
Effective Training Skills in the Pharma Industry
10-11 Oct 2024 - Online webinar
This interactive training skills and processes in pharma course is ideal for anyone with responsibility for planning or delivering training in the pharma, device or animal health industries (includes face-to-face and virtual training).
Presented by Laura Brown (bio)
Post-Market Surveillance - Practical Application for Medical Devices and IVDs
10 Oct 2024 - Online webinar
Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.
This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities.
The FDA Drug Approval Process
14-15 Oct 2024 - Online webinar
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Pharmaceutical Development of ATMPs
14-15 Oct 2024 - Online webinar
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace
14 Oct 2024 - Online webinar
Raise your knowledge of the latest laws and best practice for avoiding and, where necessary, managing these sensitive issues within the workplace.
Presented by Toni Trevett (bio)
EU Pharmaceutical Regulations & Strategy
14-15 Oct 2024 - Online webinar
The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.
Presented by Norah Lightowler (bio)
Working with Emotional Intelligence in the Pharmaceutical and Biopharma Industry
14 Oct 2024 - Online webinar
This emotional intelligence in pharma and biopharma straining course will help you learn to communicate more effectively in the pharma and biopharma industries.
"What really matters for success, character, happiness and life long achievements is a definite set of emotional skills – your EQ — not just purely cognitive abilities that are measured by IQ tests.” — Daniel Goleman
Presented by Laura Brown (bio)
Cosmetovigilance
14-15 Oct 2024 - Online webinar
This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW).
It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.
Presented by Graeme Ladds (bio)
Cyber Security for Medical Devices
15-16 Oct 2024 - Online webinar
This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.
Presented by Ben Kokx (bio)
Successfully Conducting Oral Proceedings at the EPO
15 Oct 2024 - London
Oral proceedings are organised to conclude the majority of appeal cases, and in many opposition and examination cases. Consequently, a European patent attorney will almost certainly at some point have to attend oral proceedings, either to defend a client's invention or to attack a patent held by a competitor. To defend your client's interests correctly and competently it is vital to know what to expect at those occasions and to be property prepared for it.
Presented by Joeri Beetz (bio)
Process Validation for Medical Devices
15-16 Oct 2024 - Online webinar
This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.
Presented by Stuart Angell (bio)
Advanced Veterinary Pharmacovigilance
16-17 Oct 2024 - Online webinar
Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit
Presented by Declan O'Rourke (bio)
Clean Communication
16 Oct 2024 - Online webinar
Throughout this programme you will learn how to use clean communication to convey your meaning and enhance your relationships, explore how to build rapport with others and understand how to clarify what others want of you. You'll acquire tips and hints for motivating others and practise your use of language to inspire action in others.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Compassionate Leadership and Successful, Sustainable Organisational Growth
16-17 Oct 2024 - Online webinar
This programme will explain the direct link between compassionate leadership and successful, sustainable organisational growth. The session will detail the key components of compassionate leadership and how this can be achieved in practice.
Presented by Claire Mould (bio)
Data Integrity Auditor Master Class
16-17 Oct 2024 - Online webinar
During this course data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.
Presented by Mustafa Edik (bio)
Managing Vendor/CRO/CMO Oversight
17-18 Oct 2024 - Online webinar
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
Dealing With Difficult People
17 Oct 2024 - Online webinar
During this event you will discover why people are difficult, learn to recognise classic profiles of difficult people, pre-empt challenging situations and avoid escalation, enhance your own attributes and develop coping strategies.
This is an interactive online course consisting of 2 x 90 minute modules.
Presented by Geoff Marsh (bio)
Workplace Accident Management and Investigation - from emergency planning to the final report
17 Oct 2024 - Online webinar
This masterclass will equip you with the skills and knowledge required to successfully manage an accident scene and undertake accident investigations in a workplace environment.
Presented by Andy Farrall (bio)
Practical Requirements of the Arab Pharmacovigilance Guidelines
17-18 Oct 2024 - Online webinar
Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East
Presented by Graeme Ladds (bio)
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
17-18 Oct 2024 - Online webinar
The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.
This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.
Presented by Andrew Willis (bio)
Drug/Device and Device/Drug Combinations in the EU and USA
17-18 Oct 2024 - Online webinar
Practical guidance on borderline Issues and combination products
Sterilization of Medical Devices
17-18 Oct 2024 - Online webinar
Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.
Presented by Annette Callaghan (bio)
Clinical Research Project Management
23-25 Oct 2024 - Online webinar
The leading clinical research project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
Presented by Laura Brown (bio)
An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
23 Oct 2024 - Online webinar
This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.
Presented by Greg Thay (bio)
November 2024 training courses
An Introduction to the Medical Device Regulation
4-6 Nov 2024 - Online webinar
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.
European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications
4-8 Nov 2024 - Online webinar
This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.
Presented by Graeme Ladds (bio)
Smart Packaging and Electronic Patient Information
4-5 Nov 2024 - Online webinar
Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.
Presented by Graham Howieson (bio)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
5-8 Nov 2024 - Online webinar
This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.
Litigation-Proofing and Proving your Patent Claims
5 Nov 2024 - London
This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.
Managing Competence within the Medical Device Industry
5 Nov 2024 - Online webinar
This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.
Presented by Anne Jury (bio)
A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
5 Nov 2024 - Online webinar
Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU. Regulations for CMC of veterinary pharmaceuticals are complex and are regularly updated, making pharmaceutical product development challenging. This course is designed to guide you through the essential steps in development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorisation applications.
The Role and Skills of a Valuable HR Assistant
6 Nov 2024 - Online webinar
Practical applied learning for HR professionals – a one-day intensive briefing on best practice and employment law requirements for the effective HR assistant .
Presented by Jocelyn Hughes (bio)
How to Avoid Common Pitfalls in Combined EU/US Patent Applications
6-7 Nov 2024 - London
This seminar addresses the parallel, but substantially different, rules for drafting and prosecuting patents required by the Examiners and Appeal Boards of the EPO and USPTO.
The Pharma Mini MBA
6-8 Nov 2024 - Online webinar
A three-day accelerated management programme to give you the high-performance management skills of an MBA, designed specifically for pharmaceutical/biotechnology professionals and also applicable to medical device/animal health industries
Pre-Filled Syringes: End-to-End Processing
6-7 Nov 2024 - Online webinar
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Presented by
Dale Charlton (bio)
and 3 more leading experts
Understanding and Improving Business Processes
6 Nov 2024 - Online webinar
This highly focussed course will give you the knowledge and skills to evaluate and optimise your organisations strategies for understanding and improving business processes.
Presented by Helene Russell (bio)
The Art of European Claim Drafting
7-8 Nov 2024 - London
This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.
Masterclass: Artificial Intelligence-based Medical Devices
7 Nov 2024 - Online webinar
Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust and to ensure data is portable and qualitative. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.
Presented by Koen Cobbaert (bio)
An Essential Overview of the Medical Device Industry
8 Nov 2024 - Online webinar
This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.
EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience
11-12 Nov 2024 - Online webinar
This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.
Presented by Laura Brown (bio)
Medical Device Studies: Clinical Evidence
11-12 Nov 2024 - Online webinar
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Presented by Janette Benaddi (bio)
Positive Persuading and Influencing Skills for Pharma Professionals
11-12 Nov 2024 - Online webinar
This two-day workshop will give you an opportunity to improve and enhance your persuading and influencing skills within business
Presented by Robert Hersowitz (bio)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
11-12 Nov 2024 - Online webinar
Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.
Presented by Paul Palmer (bio)
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
11-12 Nov 2024 - London
This event has been designed to give practical advice and guidance on how to successfully develop market approval in the EU. The programme will take participants through a step-by-step approach to the process and will also provide key guidance on how to maintain MA once achieved.
Presented by Mel Munro (bio)
Establishing and Nurturing Emotionally Intelligent Teams and Workplaces
11-12 Nov 2024 - Online webinar
This programme will discuss what an emotionally intelligent team is, and how this differs from a team that is just functioning (and definitely an underperforming or dysfunctional team). It will outline how establishing and nurturing an emotionally intelligent team will enhance the productivity and effectiveness of the team, and therefore the organisation as a whole.
Presented by Claire Mould (bio)
An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
11 Nov 2024 - Online webinar
Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.
Presented by Annette Callaghan (bio)
Developing High Performance HR Business Partner and Consulting Skills
12-13 Nov 2024 - Online webinar
Achieve excellence as an HR business partner and enhance your ability to deliver a positive impact and support across the whole business.
Presented by Katie Botten (bio)
Formal Requirements of the European Patent System
12-15 Nov 2024 - Online webinar
A two-day seminar for administrative staff in the patent profession on how to competently prepare an application for filing before the EPO.
*INCLUDES: Practical and interactive exercises*
Presented by Richard Gillespie (bio)
Signal Detection and Regulatory Expectations
12-15 Nov 2024 - Online webinar
This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
Presented by Graeme Ladds (bio)
Managing the Intergenerational Workplace
13 Nov 2024 - Online webinar
This interactive webinar will look at what Leaders and Managers can do to manage a blended workforce spanning four generations, that vary in their work ethics, ideas about work-life balance and long-term career goals. Practical tips will be discussed on managing intergenerational issues and how to prepare a strategy for increasing levels of inclusivity and respect with your own teams and individual team members.
Presented by Geoff Marsh (bio)
Facilities Management for Office Managers
13 Nov 2024 - Online webinar
An essential course for those responsible for facilities management within their business
Presented by Jodie Read (bio)
Drafting International Intellectual Property Agreements
14 Nov 2024 - London
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
IP and Commercialisation: Creating and Maintaining your IP Portfolio
14 Nov 2024 - Online webinar
A practical course focussing on the internal and external considerations of using IP within your business strategy.
Presented by Jane List (bio)
The Role of Wellbeing in Individual and Organisational Growth
18-19 Nov 2024 - Online webinar
This programme will discuss definitions of wellbeing, acknowledging that it has many different components. It will detail what each of these components are and the need to understand the symbiotic significance of each component. Drawing on neurological evidence the programme will examine the signs of declining Well Being, and explain the related negative outcomes to the individual and the workplace.
Presented by Claire Mould (bio)
Agile Leadership for Pharma and Biopharma Professionals in a hybrid world
18-19 Nov 2024 - Online webinar
This comprehensive two-day course will introduce you to the core concepts of what makes an excellent leader - in the context of the pharmaceutical industry - and how to apply the different skills of leading your staff and team to maximise results
Presented by Laura Brown (bio)
Understanding Active Pharmaceutical Ingredients (APIs)
18-19 Nov 2024 - Online webinar
This course has been designed to provide attendees with a fundamental understanding of best practice and the regulatory environment applicable to active pharmaceutical ingredients in the pharmaceutical industry. It will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.
Presented by Paul Palmer (bio)
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
18 Nov 2024 - Online webinar
Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.
Presented by Annette Callaghan (bio)
US FDA - Understanding Key Factors When Working with the FDA
19 Nov 2024 - Online webinar
This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration). For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.
Presented by Andrew Willis (bio)
Pharmaceutical Regulatory Affairs in Africa
19-22 Nov 2024 - Online webinar
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
UK Conformity Assessed (UKCA) Marking for Medical Devices
19 Nov 2024 - Online webinar
With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.
Presented by Janette Benaddi (bio)
An Introduction to ISO 22716 - GMP for Cosmetic Products
19-22 Nov 2024 - Online webinar
This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.
Presented by Mustafa Edik (bio)
Planning and Implementing a Health & Safety Policy
20 Nov 2024 - Online webinar
Every company needs to have a health & safety policy in place. If this is your area of responsibility, this webinar will give you the knowledge to put a policy together and to put it into practice.
Presented by Andy Farrall (bio)
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
20 Nov 2024 - Online webinar
This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.
Presented by Stuart Angell (bio)
Medical Writing for Medical Devices
21-22 Nov 2024 - Online webinar
How to produce quality regulatory documents including the clinical evaluation report (CER)
The Patent Administrator
21-22 Nov 2024 - Online webinar
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
GCP and Clinical Research Update - Hot Inspection Topics
22 Nov 2024 - Online webinar
This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.
Presented by Laura Brown (bio)
Metrics and Earned Value in Clinical Research Projects
25 Nov 2024 - Online webinar
This workshop will focus on the effective use of metrics to monitor the real progress of your clinical research project. A valuable master class for anyone involved in clinical research.
Presented by Roger Joby (bio)
Root Cause Analysis and Critical Thinking
25 Nov 2024 - Online webinar
This programme will explore the key concepts of critical thinking applied to problem solving and decision making for pharmaceutical and biopharmaceutical professionals
Presented by Laura Brown (bio)
The Common Technical Document
25-26 Nov 2024 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Understanding Computer System Validation (CSV)
25-26 Nov 2024 - Online webinar
This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5). It will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.
Presented by Paul Palmer (bio)
Ensuring Sustainability and Growth by Placing People at the Centre of the Triangulation of Policy, Process & Practice
25-26 Nov 2024 - Online webinar
This programme will provide a clear understanding of the independent yet interdependent nature of Policy, Processes, and Practice. Focusing on the importance of putting people at the centre of this triangulation.
Presented by Claire Mould (bio)
Practical Implementation of GCP in Veterinary Field Studies
26-27 Nov 2024 - London
This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.
The Role of the Senior HR Manager
26-27 Nov 2024 - Online webinar
This programme has been specifically designed for those HR professionals who operate at, or aspire to operate at, a senior level within their businesses.
Presented by Jocelyn Hughes (bio)
Veterinary Pharmaceutical Submissions in the EU
26-27 Nov 2024 - London
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, critical expert reports and regulatory submissions.
New EU GMP Annex 1: Compliant Aseptic Operations
26-28 Nov 2024 - Online webinar
Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety.
During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.
Presented by Mustafa Edik (bio)
Pharmacovigilance Aspects of Licensing Agreements
27-28 Nov 2024 - Online webinar
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
27-28 Nov 2024 - Online webinar
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Presented by Janette Benaddi (bio)
Successful Medical Writing – from Protocol to CTD
27-29 Nov 2024 - Online webinar
Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.
Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations
28 Nov 2024 - Online webinar
Analyse and discuss the key aspects of patent/know-how licences and R&D collaborations, assessing the areas where things can and do go wrong.
Presented by Richard Brady (bio)
Medical Device Single Audit Programme (MDSAP)
28-29 Nov 2024 - Online webinar
The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
Presented by Stuart Angell (bio)
The Common Technical Document (CTD) Submission in the MENA Region
28 Nov 2024 - Online webinar
This one-day course will provide you with an in depth understanding of the technical and regulatory requirements of CTD submissions in different countries in the MENA region.
Presented by Mohammad Fat'hy Elnadi (bio)
An Essential Overview of Medical Information
29 Nov 2024 - Online webinar
In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring
Presented by Graeme Ladds (bio)
December 2024 training courses
Filing eCTD Submissions
2 Dec 2024 - Online webinar
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Clinical Trial Monitoring
2-3 Dec 2024 - Online webinar
This course will assure monitors understand the importance of compliance with latest ICH GCP R3 requirements, and how these apply to monitoring clinical trials in the future.
Presented by Laura Brown (bio)
FDA Approval Process for Medical Devices
2-3 Dec 2024 - Online webinar
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.
Presented by Jonathan Hughes (bio)
The Medical Device School - From Concept to CE Marking
2-6 Dec 2024 - Online webinar
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.
Presented by
Stuart Angell (bio)
and 7 more leading experts
Biotechnology for the Non-Biotechnologist
2-6 Dec 2024 - Online webinar
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Robert Alvarez (bio)
and 6 more leading experts
The Trade Mark Administrator
2-3 Dec 2024 - Online webinar
This trade mark administrator training course is a comprehensive overview of what every trade mark administrator should know.
Presented by Victoria Silk (bio)
Essential Skills for Writing Successful Business Cases
3 Dec 2024 - Online webinar
This masterclass will give you the skills and understanding to write clear, compelling and factual documents to give your business initiatives the best chance of success.
Presented by Helene Russell (bio)
Understanding the European Unitary Patent and Unified Patent Court (UPC)
4 Dec 2024 - Online webinar
The European Patent landscape is set to change radically in June 2023 with the Unitary Patent and Unified Patent Court coming into force. This intensive one-day course will give you essential insights into unitary patents, the UPC and how the new patent system will impact your business.
Presented by Olivier Corticchiato (bio)
IP Due Diligence & Freedom to Operate in Practice
4 Dec 2024 - London
This intensive one-day course will give you many insights into the best practice of organising and conducting an efficient and thorough IP due diligence project.
Building and Managing a Patent Portfolio to Best Support your Business
4 Dec 2024 - Online webinar
A comprehensive one-day course that takes you through the IP commercialisation process to understand how to make the most of IP within your business.
Presented by Olivier Corticchiato (bio)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
5-6 Dec 2024 - Online webinar
Applying HF and usability to comply with the MDR.
This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.
Presented by Richard Featherstone (bio)
Patent Protection for Software-Related Inventions in Europe and the USA
5 Dec 2024 - London
An intensive update on patent protection for software-related inventions covering all the major developments in European patent law in particular GUI inventions and 'mixed' inventions with both patentable and non-patentable subject matter.
Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
5 Dec 2024 - Online webinar
The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.
Presented by Annette Callaghan (bio)
Data Integrity and Document Management
6 Dec 2024 - Online webinar
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.
Presented by Laura Brown (bio)
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
9-12 Dec 2024 - Online webinar
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Medical Device Regulation in the Eurasian Union, Russia and the CIS
9-10 Dec 2024 - Online webinar
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Presented by Anna Harrington-Morozova (bio)
Project Management for Pharma Professionals
9-10 Dec 2024 - Online webinar
The leading project management course designed specifically for the pharma/bio industries – also applicable to those working in medical devices and animal health
Includes: Interactive workshop sessions
Presented by Laura Brown (bio)
Pharmaceutical Regulatory Affairs in the Middle East
9-10 Dec 2024 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Advanced Pharmacovigilance
9-13 Dec 2024 - Online webinar
This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.
Presented by Graeme Ladds (bio)
An Introduction to the Design and Development of Medical Devices
10-11 Dec 2024 - Online webinar
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by David Howlett (bio)
Pharmaceutical Regulatory Affairs in China
10-11 Dec 2024 - Online webinar
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
The Role of an Effective HR Advisor
10-11 Dec 2024 - Online webinar
This practical two-day programme is a must-attend event for any newly promoted or aspiring HR advisors, as well as those looking for a refresher.
Presented by Jocelyn Hughes (bio)
Best Practice for Writing Effective SOPs
12 Dec 2024 - Online webinar
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Non-Conformance and Corrective Action for Medical Device Manufacturers
12 Dec 2024 - Online webinar
The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.
Presented by Annette Callaghan (bio)
CAPA (Corrective and Preventative Action)
13 Dec 2024 - Online webinar
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement, and planning and implementation in process improvements and CAPA.
Presented by Laura Brown (bio)