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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
Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
4 Jun 2024 - Online webinar
Also on: 5 Dec 2024
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)
A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
18 Mar 2024 - Online webinar
Also on: 5 Nov 2024
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.
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
11-12 Mar 2024 - Online webinar
Also on: 11 Nov 2024
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)
A Practical Guide to Producing and Maintaining the PSMF
19 Jan 2024 - Online webinar
Also on: 24 Apr 2024
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)
A Practical Guide to Writing Risk Management Plans (RMPs)
18 Jan 2024 - Online webinar
Also on: 16 Apr 2024
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
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
Advanced Pharmacovigilance
11-15 Dec 2023 - Online webinar
Also on: 20 Mar 2024
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)
Advanced Regulatory Affairs for Medical Devices
1-2 Feb 2024 - Online webinar
Also on: 4 Jun 2024
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Advanced Veterinary Pharmacovigilance
22-25 Jan 2024 - Online webinar
Also on: 16 Apr 2024
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)
Agile Leadership for Pharma and Biopharma Professionals in a hybrid world
7-8 Mar 2024 - Online webinar
Also on: 4 Jul 2024
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)
An Essential Overview of Medical Information
15 Mar 2024 - Online webinar
Also on: 11 Jul 2024
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)
An Essential Overview of Pharmacovigilance
29 Jan 2024 - Online webinar
Also on: 16 May 2024
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
An Essential Overview of the Medical Device Industry
1 Mar 2024 - Online webinar
Also on: 8 Jul 2024
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.
An Essential Overview of the Pharmaceutical and Biotech Industries
19 Jan 2024 - Online webinar
Also on: 10 May 2024
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)
An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
1 May 2024 - Online webinar
Also on: 11 Nov 2024
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)
An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals
24 Apr 2024 - Online webinar
Also on: 10 Jul 2024
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)
An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices
21 May 2024 - Online webinar
Also on: 18 Nov 2024
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)
An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices
6 Mar 2024 - Online webinar
Also on: 4 Jul 2024
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 ISO 22716 - GMP for Cosmetic Products
19-20 Mar 2024 - Online webinar
Also on: 17 Jul 2024
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)
An Introduction to Pharmaceutical Packaging
30 Jan-1 Feb 2024 - Online webinar
Also on: 20 May 2024
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)
An Introduction to the Design and Development of Medical Devices
22-23 Apr 2024 - Online webinar
Also on: 24 Jul 2024
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by David Howlett (bio)
An Introduction to the Medical Device Regulation
6-8 Feb 2024 - Online webinar
Also on: 15 May 2024
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.
Artificial Intelligence and Machine Learning Powered Signal Management
24 Jan 2024 - Online webinar
Also on: 15 May 2024
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)
Best Practice for Writing Effective SOPs
14 Dec 2023 - Online webinar
Also on: 23 Apr 2024
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Biological Evaluation of Medical Devices
11-12 Mar 2024 - London
Also on: 16 Sep 2024
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
Biosimilars
5-6 Mar 2024 - Online webinar
Also on: 10 Jul 2024
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Biotechnology for the Non-Biotechnologist
4-8 Dec 2023 - Online webinar
Also on: 24 Apr 2024
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
CAPA (Corrective and Preventative Action)
15 Dec 2023 - Online webinar
Also on: 22 Apr 2024
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)
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
29 Feb-1 Mar 2024 - Online webinar
Also on: 27 Jun 2024
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)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
29-30 Nov 2023 - Online webinar
Also on: 26 Feb 2024
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
7-8 Feb 2024 - Online webinar
Also on: 19 Jun 2024
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)
Clinical Quality Management Systems
25-26 Jan 2024 - Online webinar
Also on: 23 May 2024
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
Clinical Research - A Different Approach to Successful Project Delivery
16 Feb 2024 - Online webinar
Also on: 10 Jun 2024
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)
Clinical Trial Monitoring
29-30 Apr 2024 - Online webinar
Also on: 11 Jul 2024
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)
Clinical Trial Regulatory Requirements
22-23 Jan 2024 - Online webinar
Also on: 2 May 2024
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)
Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration
20 Mar 2024 - Online webinar
Also on: 18 Sep 2024
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)
Consultative Selling for Pharma Professionals
15-16 Jan 2024 - Online webinar
Also on: 13 May 2024
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)
Cosmetovigilance
5-6 Feb 2024 - Online webinar
Also on: 20 Jun 2024
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
30-31 Jan 2024 - Online webinar
Also on: 2 May 2024
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)
Data Integrity and Document Management
12 Apr 2024 - Online webinar
Also on: 22 Jul 2024
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)
Data Integrity Auditor Master Class
30-31 Jan 2024 - Online webinar
Also on: 30 Apr 2024
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)
Delivery of Biologics to the Nasal Cavity
6 Feb 2024 - Online webinar
Also on: 4 Jun 2024
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
Development of Combination Products: Critical Interactions
12-13 Feb 2024 - Online webinar
Also on: 25 Jun 2024
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Presented by Andrew Willis (bio)
Drug Discovery: A Step-by-Step Introduction
25-26 Jan 2024 - Online webinar
Also on: 9 May 2024
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)
Drug/Device and Device/Drug Combinations in the EU and USA
14-15 Feb 2024 - Online webinar
Also on: 17 Oct 2024
Practical guidance on borderline Issues and combination products
Effective Technical Writing & Editing
1 Feb 2024 - Online webinar
Also on: 28 Jun 2024
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)
Effective Technology Transfer
23-24 Jan 2024 - Online webinar
Also on: 16 Apr 2024
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
Effective Training Skills in the Pharma Industry
29 Feb-1 Mar 2024 - Online webinar
Also on: 13 Jun 2024
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)
EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience
15-16 Feb 2024 - Online webinar
Also on: 20 May 2024
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)
EU Pharmaceutical Regulations & Strategy
12-13 Feb 2024 - Online webinar
Also on: 11 Jun 2024
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)
EU Proposed Pharmaceutical Legislation Changes
24 Jan 2024 - Online webinar
Also on: 22 May 2024
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)
European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications
4-8 Mar 2024 - Online webinar
Also on: 15 Jul 2024
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)
FDA Approval Process for Medical Devices
4-7 Mar 2024 - Online webinar
Also on: 19 Jun 2024
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)
Filing eCTD Submissions
25 Apr 2024 - Online webinar
Also on: 19 Jul 2024
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
GCP and Clinical Research Update - Hot Inspection Topics
15 Mar 2024 - Online webinar
Also on: 1 Jul 2024
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)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
5-6 Mar 2024 - Online webinar
Also on: 5 Jun 2024
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)
ICH Q9(R1) Quality Risk Management (QRM)
31 Jan 2024 - Online webinar
Also on: 1 May 2024
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)
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
Also on: 24 Jul 2024
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.
Introduction to Veterinary Pharmacovigilance
5-8 Feb 2024 - Online webinar
Also on: 27 Jun 2024
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)
Managing Competence within the Medical Device Industry
1 May 2024 - Online webinar
Also on: 5 Nov 2024
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)
Managing Vendor/CRO/CMO Oversight
15-16 Jan 2024 - Online webinar
Also on: 18 Apr 2024
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
Masterclass: Artificial Intelligence-based Medical Devices
6 Mar 2024 - Online webinar
Also on: 26 Jul 2024
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)
MBA Strategic Thinking for Pharma and Biopharma Professionals
29-30 Jan 2024 - Online webinar
Also on: 25 Apr 2024
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)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
11-12 Dec 2023 - Online webinar
Also on: 16 Apr 2024
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)
Medical Device Regulations in the Middle East and North Africa
5-6 Feb 2024 - Online webinar
Also on: 11 Jun 2024
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
Medical Device Single Audit Programme (MDSAP)
30 Nov-1 Dec 2023 - Online webinar
Also on: 25 Mar 2024
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.
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
11-14 Dec 2023 - Online webinar
Also on: 22 Apr 2024
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Medical Device Studies: Clinical Evidence
18-21 Mar 2024 - Online webinar
Also on: 10 Jul 2024
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Presented by Janette Benaddi (bio)
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
17-18 Jan 2024 - Online webinar
Also on: 21 May 2024
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)
Medical Writing for Medical Devices
13-14 Mar 2024 - Online webinar
Also on: 1 Jul 2024
How to produce quality regulatory documents including the clinical evaluation report (CER)
Metered Dose Inhaler (MDI) Technology
26-29 Feb 2024 - Online webinar
Also on: 20 Jun 2024
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
Metrics and Earned Value in Clinical Research Projects
6 Mar 2024 - Online webinar
Also on: 11 Jul 2024
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)
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.
New EU GMP Annex 1: Compliant Aseptic Operations
12-14 Mar 2024 - Online webinar
Also on: 2 Jul 2024
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)
Non-Conformance and Corrective Action for Medical Device Manufacturers
19 Jun 2024 - Online webinar
Also on: 12 Dec 2024
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)
Pharmaceutical Development of ATMPs
5-8 Feb 2024 - Online webinar
Also on: 18 Jun 2024
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Presented by Andrew Willis (bio)
Pharmaceutical Regulatory Affairs in Africa
7-8 Mar 2024 - Online webinar
Also on: 23 Jul 2024
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Pharmaceutical Regulatory Affairs in Asia
27-29 Feb 2024 - Online webinar
Also on: 12 Jun 2024
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
Pharmaceutical Regulatory Affairs in China
12-13 Dec 2023 - Online webinar
Also on: 29 Apr 2024
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
8-9 Feb 2024 - Online webinar
Also on: 24 Jun 2024
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)
Pharmaceutical Regulatory Affairs in the Middle East
22-23 Apr 2024 - Online webinar
Also on: 17 Jul 2024
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Pharmacovigilance
31 Jan-2 Feb 2024 - Online webinar
Also on: 12 Jun 2024
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 Aspects of Licensing Agreements
29-30 Nov 2023 - Online webinar
Also on: 1 Mar 2024
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge
31 Jan-2 Feb 2024 - Online webinar
Also on: 8 May 2024
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)
Pharmacovigilance QMS & Inspection Preparation
22-25 Jan 2024 - Online webinar
Also on: 20 May 2024
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
Positive Persuading and Influencing Skills for Pharma Professionals
18-19 Mar 2024 - Online webinar
Also on: 29 Jul 2024
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)
Post-Market Surveillance - Practical Application for Medical Devices and IVDs
14 Feb 2024 - Online webinar
Also on: 6 Jun 2024
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.
Practical Implementation of GCP in Veterinary Field Studies
19-20 Mar 2024 - Online webinar
Also on: 26 Nov 2024
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.
Practical Requirements of the Arab Pharmacovigilance Guidelines
13-14 Feb 2024 - Online webinar
Also on: 13 Jun 2024
Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East
Presented by Graeme Ladds (bio)
Pre-Filled Syringes: End-to-End Processing
21-22 Mar 2024 - Online webinar
Also on: 25 Jul 2024
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
Process Validation for Medical Devices
7-8 Feb 2024 - Online webinar
Also on: 5 Jun 2024
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)
Process Validation with Qualification
16-17 Jan 2024 - Online webinar
Also on: 21 May 2024
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)
Project Management for Pharma Professionals
4-5 Dec 2023 - Online webinar
Also on: 11 Mar 2024
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)
Registration of Veterinary Vaccines in the USA and Canada
17-18 Jan 2024 - Online webinar
Also on: 1 May 2024
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)
Regulatory Affairs for Support Staff
29-30 Jan 2024 - Online webinar
Also on: 13 May 2024
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)
Regulatory Strategies for Orphan Drugs
15 Feb 2024 - Online webinar
Also on: 24 Jun 2024
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
2 Feb 2024 - Online webinar
Also on: 7 Jun 2024
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)
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)
Root Cause Analysis and Critical Thinking
22 Mar 2024 - Online webinar
Also on: 23 Jul 2024
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)
Signal Detection and Regulatory Expectations
18-19 Mar 2024 - Online webinar
Also on: 1 Jul 2024
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)
Smart Packaging and Electronic Patient Information
14 Mar 2024 - Online webinar
Also on: 10 Jul 2024
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)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
4-7 Mar 2024 - Online webinar
Also on: 11 Jul 2024
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)
Sterilization of Medical Devices
1-2 Feb 2024 - Online webinar
Also on: 6 Jun 2024
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)
Successful Medical Writing – from Protocol to CTD
20-22 Mar 2024 - Online webinar
Also on: 24 Jul 2024
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.
Sustainable Design and Manufacture for Medical Devices
23 Jan 2024 - Online webinar
Also on: 25 Apr 2024
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)
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.
The Common Technical Document
12-13 Mar 2024 - Online webinar
Also on: 2 Jul 2024
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
The Common Technical Document (CTD) Submission in the MENA Region
14 Mar 2024 - Online webinar
Also on: 10 Jul 2024
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 FDA Drug Approval Process
6-7 Feb 2024 - Online webinar
Also on: 12 Jun 2024
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
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
The Medical Device School - From Concept to CE Marking
10-14 Jun 2024 - London
Also on: 2 Dec 2024
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
The Pharma Mini MBA
7-9 Feb 2024 - Online webinar
Also on: 15 May 2024
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
The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR
24 Jan 2024 - Online webinar
Also on: 21 May 2024
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)
UK Conformity Assessed (UKCA) Marking for Medical Devices
1 Mar 2024 - Online webinar
Also on: 15 Jul 2024
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)
Understanding Active Pharmaceutical Ingredients (APIs)
13-14 Mar 2024 - Online webinar
Also on: 17 Jul 2024
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)
Understanding Computer System Validation (CSV)
19-20 Mar 2024 - Online webinar
Also on: 24 Jul 2024
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)
Understanding Pharmacovigilance Regulations in APAC
23-24 Jan 2024 - Online webinar
Also on: 23 Apr 2024
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
US FDA - Understanding Key Factors When Working with the FDA
19 Mar 2024 - Online webinar
Also on: 18 Jul 2024
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)
Variations to Marketing Authorisations
1-2 Feb 2024 - Online webinar
Also on: 4 Jun 2024
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)
Veterinary Pharmaceutical Submissions in the EU
12-13 Dec 2023 - London
Also on: 4 Mar 2024
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.
Working with Emotional Intelligence in the Pharmaceutical and Biopharma Industry
12 Feb 2024 - Online webinar
Also on: 21 Jun 2024
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)