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January 2022 training courses
Clinical Trial Regulatory Requirements
27-28 Jan 2022 - 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 and key difference it compares with the Clinical Directive requirements.
Presented by Laura Brown (bio)
Negotiating and Drafting IT Contracts
31 Jan-1 Feb 2022 - Online webinar
A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.
Presented by Mark Weston (bio)
February 2022 training courses
Common Technical Document
1-2 Feb 2022 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
3-4 Feb 2022 - 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)
The Pharma Mini MBA
7-9 Feb 2022 - 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
Biological Evaluation of Medical Devices
8-9 Feb 2022 - 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
Effective Technical Writing & Editing
9 Feb 2022 - 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)
Presenting Virtually
10 Feb 2022 - 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)
EU Clinical Trial Regulation 536/2014: Overview and Implementation
21-22 Feb 2022 - Online webinar
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU
Presented by Laura Brown (bio)
The Role and Responsibilities of the Contracts Manager
22-23 Feb 2022 - Online webinar
Getting from contract agreement to successful contract completion.
Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.
Presented by Catherine Hurst (bio)
Drafting and Negotiating Clinical Trial Agreements
24 Feb 2022 - Online webinar
This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted
Presented by Alex Denoon (bio)
New Regulations for Medical Devices and IVDs in Europe
24-25 Feb 2022 - Online webinar
During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.
Managing stress & anxiety
24 Feb 2022 - Online webinar
A 60-90 minute webinar exploring stress & anxiety.
14:00 UK
The Patent Administrator
25 Feb 2022 - Online webinar
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
Business and Contract Law
28 Feb-1 Mar 2022 - Online webinar
A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.
Presented by Arun Singh OBE (bio)
Managing the Intergenerational Workplace
28 Feb 2022 - Online webinar
This interactive webinar will look at what Leaders and Managers can to 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)
March 2022 training courses
US Patent Practice
1-2 Mar 2022 - 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
Advanced Pharmacovigilance
1-3 Mar 2022 - 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)
Advanced Regulatory Affairs for Medical Devices
1-2 Mar 2022 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
An Essential Overview of the Pharmaceutical and Biotech Industries
1 Mar 2022 - 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)
Ownership and Control of Intellectual Property Rights
2 Mar 2022 - Online webinar
In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit
Presented by Mark Weston (bio)
Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations
2 Mar 2022 - 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 Simon Portman (bio)
Drafting International R&D Collaboration and Joint Venture Agreements
3 Mar 2022 - Online webinar
Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.
Presented by Rebecca Attree (bio)
Agile Leadership for Pharma and Biopharma Professionals in a virtual world
3-4 Mar 2022 - 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)
Biotechnology for the Non-Biotechnologist
7-9 Mar 2022 - London
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Adrian Haines (bio)
and 6 more leading experts
Litigation-Proofing and Proving your Patent Claims
7 Mar 2022 - Online webinar
This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.
Effective Candidate Sourcing & Selection
7 Mar 2022 - Online webinar
This highly practical workshop provides a step-by-step approach to the recruitment and selection process, including the challenges of holding virtual interviews and online selection asssessments events. The course will cover techniques for advert writing, interview skills and selection tecniques, all to help you attract and select the right candidates. It is ideal for HR professionals and HR involved in staff recruitment
Presented by Graham Roberts-Phelps (bio)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
8-9 Mar 2022 - 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)
EPO Oppositions and Appeals - the Case Law and Workshop
8-9 Mar 2022 - Online webinar
Updated for 2021! Drawing on case law and the experience of the faculty, this seminar considers the present workings of the opposition and appeal procedures at the European Patent Office. It provides an in-depth summary of both background and recent developments at the EPO and explains how these will impact on your day-to-day practice. It will give you the knowledge and skills to navigate this highly technical area.
3-day Drafting Commercial Contracts
8-10 Mar 2022 - Online webinar
A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.
Presented by Mark Weston (bio)
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
9-10 Mar 2022 - 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)
GCP and Clinical Research Update - Hot Inspection Topics
10 Mar 2022 - Online webinar
This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments
Presented by Laura Brown (bio)
Drug/Device and Device/Drug Combinations in the EU and USA
10-11 Mar 2022 - Online webinar
Practical guidance on borderline Issues and combination products
Presented by
Tina Amini (bio)
and 3 more leading experts
IP Due Diligence & Freedom to Operate in Practice
10-11 Mar 2022 - 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.
Presented by
Tim May (bio)
and 3 more leading experts
Process Validation with Qualification
14-15 Mar 2022 - 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)
Managing Remote Teams
14 Mar 2022 - 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)
Running Virtual Meetings
15 Mar 2022 - Online webinar
This programme has been designed to help you learn how to prepare and construct a virtual meeting. You will explore the advantages and disadvantages of the various available platforms, understand how to ensure your virtual meeting is engaging and interactive, and practise delivering elements of a virtual meeting in an engaging and interactive manner.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Understanding and Managing Competition Law Compliance
15 Mar 2022 - Online webinar
Learn how to navigate competition law and ensure compliance while maximising opportunities for your business
Presented by Rebecca Attree (bio)
Regulatory Strategies for Orphan Drugs
16 Mar 2022 - Online webinar
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer (bio)
The Role of the Senior HR Manager
16-17 Mar 2022 - 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)
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
17-18 Mar 2022 - 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.
How to Avoid Common Pitfalls in Combined EU/US Patent Applications
17-18 Mar 2022 - Online webinar
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.
SMART Packaging and Electronic Patient Information
17 Mar 2022 - 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). These technologies have grown in importance providing patients and medical staff with product data, reminders, healthcare delivery and diagnostic tools.
Presented by Christopher Waterhouse (bio)
Liabilities, Damages and other Contentious Issues in International Commercial Agreements
21-22 Mar 2022 - Online webinar
Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.
Presented by Arun Singh OBE (bio)
The FDA Drug Approval Process
21-22 Mar 2022 - Online webinar
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Strategic IP Planning
21-25 Mar 2022 - Online webinar
A step-by-step practical guide to strategic IP planning
Presented by Arnaud Gasnier (bio)
4-day International Commercial Contracts School
21-24 Mar 2022 - Online webinar
This specially designed four-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.
Presented by Mark Weston (bio)
FDA Approval Process for Medical Devices
23-24 Mar 2022 - 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)
Patent Protection for Software-Related Inventions in Europe and the USA
24-25 Mar 2022 - 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.
Project Management for Pharma Professionals
24-25 Mar 2022 - 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)
An Introduction to Pharmaceutical Packaging
28-29 Mar 2022 - 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)
Regulatory Affairs for Support Staff
28-29 Mar 2022 - 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)
Pre-Filled Syringes: End-to-End Processing
30-31 Mar 2022 - 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.
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
30 Mar 2022 - 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)
Metered Dose Inhaler (MDI) Technology
31 Mar-1 Apr 2022 - Online webinar
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
MBA Strategic Thinking for Pharma and Biopharma Professionals
31 Mar-1 Apr 2022 - 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)
April 2022 training courses
Drafting Commercial Contracts
4-5 Apr 2022 - Online webinar
A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.
Presented by Mark Weston (bio)
Biosimilars
4-5 Apr 2022 - Online webinar
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Presented by Marloes van der Geer (bio)
A Practical Guide to Writing Risk Management Plans (RMPs)
4 Apr 2022 - London
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
Data Integrity and Document Management
5 Apr 2022 - 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)
An Introduction to the Design and Development of Medical Devices
5-6 Apr 2022 - 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)
A Practical Guide to Producing and Maintaining the PSMF
5 Apr 2022 - London
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)
Medical Writing for Medical Devices
6-7 Apr 2022 - Online webinar
How to produce quality regulatory documents including the clinical evaluation report (CER)
Dealing With Difficult People
6 Apr 2022 - 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)
Effective Technology Transfer
6-7 Apr 2022 - Online webinar
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
EU Clinical Trial Regulation 536/2014: Overview and Implementation
7-8 Apr 2022 - Online webinar
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU
Presented by Laura Brown (bio)
Employment Law in Practice from Recruitment to Termination
7-8 Apr 2022 - Online webinar
Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.
Presented by Toni Trevett (bio)
An Essential Overview of Pharmacovigilance
8 Apr 2022 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
Freedom-to-Operate Searching
11 Apr 2022 - 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)
EU Pharmaceutical Regulations & Strategy
11-12 Apr 2022 - Online webinar
The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.
The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.
Presented by Norah Lightowler (bio)
Managing Vendor/CRO/CMO Oversight
11-12 Apr 2022 - Online webinar
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace
11 Apr 2022 - 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)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
12-13 Apr 2022 - 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 Asia
20-22 Apr 2022 - 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
Pharmaceutical Development of ATMPs
25-26 Apr 2022 - Online webinar
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Filing eCTD Submissions
25 Apr 2022 - Online webinar
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Pharmacovigilance Aspects of Licensing Agreements
25 Apr 2022 - Online webinar
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
25-28 Apr 2022 - Online webinar
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Introduction to Veterinary Pharmacovigilance
26-27 Apr 2022 - 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)
Variations to Marketing Authorisations
26-27 Apr 2022 - 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)
Nasal Drug Delivery
26-27 Apr 2022 - Online webinar
A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.
Presented by
Michael Benninger (bio)
and 12 more leading experts
Negotiating and Drafting IT Contracts
27-28 Apr 2022 - Online webinar
A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.
Presented by Mark Weston (bio)
Successful Medical Writing
27-29 Apr 2022 - 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.
Practical Implementation of GCP in Veterinary Field Studies
28-29 Apr 2022 - 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.
Effective Communication Skills for Managers
28-29 Apr 2022 - Online webinar
In the evolving workplace, effective management communication has never been more important, to not only help maintain productivity, but also to enhance team dynamics and improve staff retention. This interactive 2 day workshop will examine the key principles of communication and help you to identify your own communication style and develop techniques to improve your communication with others. The course will cover key elements of communications in management including, motivation, goal setting, delegating and giving feedback. We will also discuss one of the most under-rated communication skills: Listening
Presented by Susan Croft (bio)
Risk Management for Pharma and Biopharma Professionals
29 Apr 2022 - 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)
May 2022 training courses
Advanced Drafting Techniques for Successful EPO Patent Applications
4 May 2022 - 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 Veterinary Pharmacovigilance
4-5 May 2022 - 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)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
4-5 May 2022 - 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)
Developing High Performance HR Business Partner and Consulting Skills
4-5 May 2022 - 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)
Effectively Managing Legal Risk and Preserving Reputation
4-5 May 2022 - London
This practical and interactive two-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.
Development of Combination Products: Critical Interactions
5-6 May 2022 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
Common Technical Document
5-6 May 2022 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Root Cause Analysis and Critical Thinking
6 May 2022 - 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 Studies: Clinical Evidence
9-10 May 2022 - 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)
Drafting and Negotiating International Agency and Distribution Agreements
9-10 May 2022 - Online webinar
Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
*INCLUDES: Practical and interactive exercises*
Presented by Michala Meiselles (bio)
Formal Requirements of the European Patent System
9-10 May 2022 - 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 Petra Schmitz (bio)
Drafting Commercial Contracts for the Pharmaceutical Industry
9-11 May 2022 - Online webinar
A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.
Presented by
James Agnew (bio)
and 10 more leading experts
Drafting International Commercial Agreements in English
10-12 May 2022 - Online webinar
The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.
Presented by Alan Simmons (bio)
Effective Defence of EPO Patent Applications
11 May 2022 - 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)
Influencing, Persuading and Negotiating Skills for International Lawyers
12-13 May 2022 - Online webinar
A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*
Presented by Arun Singh OBE (bio)
How to Improve Accuracy and Attention to Detail
13 May 2022 - 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)
Drafting and Negotiating Clinical Trial Agreements
13 May 2022 - Online webinar
This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted
Presented by Alex Denoon (bio)
The Patent Administrator
13 May 2022 - Online webinar
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
Signal Detection and Regulatory Expectations
16-17 May 2022 - 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)
The New EU Animal Health Legislation for Veterinary Medicinal Products
16-17 May 2022 - Online webinar
The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.
Presented by Julian Braidwood (bio)
Recruiting a High Performance Global Workforce Within the Law
16-17 May 2022 - Online webinar
An intensive and practical two-day programme for HR professionals and line managers.
Raise your knowledge of the latest laws and best practice for recruiting overseas nationals and learn how to integrate them effectively into your current workforce.
Presented by Jocelyn Hughes (bio)
Drafting Effective Pharmaceutical Patents
17-18 May 2022 - Online webinar
*New for 2020!*
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.
Positive Persuading and Influencing Skills for Pharma Professionals
17-18 May 2022 - 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 Mini MBA for In-house Lawyers
17-20 May 2022 - London
Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department
The Pharma Mini MBA
18-20 May 2022 - 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
Presented by Laura Brown (bio)
An Introduction to the Medical Device Regulation
18-20 May 2022 - 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 Role and Responsibilities of the Contracts Manager
18-19 May 2022 - Online webinar
Getting from contract agreement to successful contract completion.
Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.
Presented by Catherine Hurst (bio)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
19-20 May 2022 - 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.
Clean Communication
20 May 2022 - 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)
An Essential Overview of the Medical Device Industry
23 May 2022 - 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.
Pharmacovigilance QMS & Inspection Preparation
23-24 May 2022 - Online webinar
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
Mental Resilience in a Home-working Environment
23 May 2022 - Online webinar
This programme will help you consider why a positive attitude is the key to home working and encourage you to develop disciplines for maximising the effectiveness of home working. You'll learn how to overcome issues of loneliness and isolation, develop coping strategies for maintaining self-confidence and self-worth and learn how to achieve and maintain a work/life balance when working remotely.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
IP Department Roadmap
23-24 May 2022 - 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)
The Art of European Claim Drafting
24-25 May 2022 - Online webinar
This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.
Drafting International Intellectual Property Agreements
24 May 2022 - Online webinar
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
Technical Documentation to Comply with the MDR and IVDR
25-26 May 2022 - Online webinar
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
Pharmaceutical Regulatory Affairs in Africa
25-26 May 2022 - Online webinar
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 China
25-26 May 2022 - Online webinar
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
Virtual Management Skills
25 May 2022 - London
Every manager wants to lead a group of high performing, productive and motivated professionals, who in turn want good working relationships with colleagues, co-workers and managers. But how can this best be achieved when working virtually and online most of the time...?
Examine the ways to overcome challenges in virtual communication, supervision, inclusion and accountability. The programme will be based on recent research and latest best practice on how to lead, direct and interact with your team virtually, including freelance and overseas staff
Presented by Graham Roberts-Phelps (bio)
Clinical Quality Management Systems
26-27 May 2022 - Online webinar
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
Reviewing and Negotiating Technology Transfer and Licensing Agreements
26-27 May 2022 - Online webinar
Providing key legal and commercial skills essential to secure a successful agreement.
Presented by Michala Meiselles (bio)
June 2022 training courses
Drafting International R&D Collaboration and Joint Venture Agreements
7 Jun 2022 - London
Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.
Presented by Rebecca Attree (bio)
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
7-8 Jun 2022 - London
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)
Drug/Device and Device/Drug Combinations in the EU and USA
7-8 Jun 2022 - London
Practical guidance on borderline Issues and combination products
Presented by
Tina Amini (bio)
and 3 more leading experts
Advanced Pharmacovigilance
7-9 Jun 2022 - 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)
US Patent Practice
8-9 Jun 2022 - 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
Veterinary Pharmaceutical Submissions in the EU
9-10 Jun 2022 - Online webinar
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.
5-day International Commercial Contracts School
12-16 Jun 2022 - London
This specialist five-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.
Presented by Arun Singh OBE (bio)
An Introduction to Pharmaceutical Packaging
13-14 Jun 2022 - 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)
The Medical Device School - From Concept to CE Marking
13-17 Jun 2022 - 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 Janette Benaddi (bio)
Building Self-Belief & Resilience
13 Jun 2022 - 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)
Medical Device Regulations in the Middle East and North Africa
15-16 Jun 2022 - 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
Effective Technical Writing & Editing
15 Jun 2022 - London
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)
IP Due Diligence & Freedom to Operate in Practice
15 Jun 2022 - 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.
Presented by
Tim May (bio)
and 3 more leading experts
GCP and Clinical Research Update - Hot Inspection Topics
16 Jun 2022 - London
This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments
Presented by Laura Brown (bio)
Borderlines between Medicines and Food
16 Jun 2022 - Online webinar
This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them
Patent Protection for Software-Related Inventions in Europe and the USA
16 Jun 2022 - 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.
The FDA Drug Approval Process
20-21 Jun 2022 - London
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Process Validation with Qualification
20-21 Jun 2022 - 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)
Business and Contract Law
20-21 Jun 2022 - Online webinar
A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.
Presented by Arun Singh OBE (bio)
Registration of Animal Feed Additives in the EU
20-21 Jun 2022 - Online webinar
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
Presented by Elinor McCartney (bio)
Working Through Veterinary Drug Development in the EU and USA
20-24 Jun 2022 - Online webinar
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
Presented by David Petrick (bio)
Metered Dose Inhaler (MDI) Technology
20-21 Jun 2022 - London
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
Project Management for Pharma Professionals
20-21 Jun 2022 - 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)
Ownership and Control of Intellectual Property Rights
20 Jun 2022 - London
In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit
Presented by Mark Weston (bio)
Pharmacovigilance
21-23 Jun 2022 - 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 6 more leading experts
FDA Approval Process for Medical Devices
22-23 Jun 2022 - 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)
Liabilities, Damages and other Contentious Issues in International Commercial Agreements
22-23 Jun 2022 - London
Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.
Presented by Arun Singh OBE (bio)
Managing the Intergenerational Workplace
22 Jun 2022 - Online webinar
This interactive webinar will look at what Leaders and Managers can to 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)
Regulatory Strategies for Orphan Drugs
27 Jun 2022 - London
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer (bio)
3-day Drafting Commercial Contracts
27-29 Jun 2022 - Online webinar
A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.
Presented by Mark Weston (bio)
Best Practice for Writing Effective SOPs
27 Jun 2022 - 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)
Biotechnology for the Non-Biotechnologist
27-29 Jun 2022 - 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
Adrian Haines (bio)
and 6 more leading experts
Pharmaceutical Packaging, Labelling and Artwork Origination
27-28 Jun 2022 - London
This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.
Presented by
George Barrie (bio)
and 6 more leading experts
Regulatory Affairs for Support Staff
27-28 Jun 2022 - 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)
CAPA (Corrective and Preventative Action)
28 Jun 2022 - Online webinar
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.
Presented by Laura Brown (bio)
Pharmaceutical Regulatory Affairs in the Middle East
29-30 Jun 2022 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
Practical Implementation of GCP in Veterinary Field Studies
30 Jun-1 Jul 2022 - 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.
Effective Candidate Sourcing & Selection
30 Jun 2022 - London
This highly practical workshop provides a step-by-step approach to the recruitment and selection process, including the challenges of holding virtual interviews and online selection asssessments events. The course will cover techniques for advert writing, interview skills and selection tecniques, all to help you attract and select the right candidates. It is ideal for HR professionals and HR involved in staff recruitment
Presented by Graham Roberts-Phelps (bio)
July 2022 training courses
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
4-7 Jul 2022 - London
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
Biosimilars
4-5 Jul 2022 - London
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Presented by Marloes van der Geer (bio)
An Introduction to the Design and Development of Medical Devices
4-5 Jul 2022 - London
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
Presented by David Howlett (bio)
Drafting Commercial Contracts
4-5 Jul 2022 - London
A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.
Presented by Mark Weston (bio)
Dealing With Difficult People
4 Jul 2022 - London
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)
Effective Technology Transfer
4-5 Jul 2022 - London
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
EU Clinical Trial Regulation 536/2014: Overview and Implementation
4-5 Jul 2022 - London
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU
Presented by Laura Brown (bio)
How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace
4 Jul 2022 - London
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)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
5-6 Jul 2022 - London
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)
Introduction to Veterinary Pharmacovigilance
5-6 Jul 2022 - London
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 Writing for Medical Devices
5-6 Jul 2022 - London
How to produce quality regulatory documents including the clinical evaluation report (CER)
EU Pharmaceutical Regulations & Strategy
5-6 Jul 2022 - London
The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.
The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.
Presented by Norah Lightowler (bio)
The Role of an Effective HR Advisor
5-6 Jul 2022 - 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)
Employment Law in Practice from Recruitment to Termination
5-6 Jul 2022 - London
Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.
Presented by Toni Trevett (bio)
Data Integrity and Document Management
7 Jul 2022 - London
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)
Litigation-Proofing and Proving your Patent Claims
7 Jul 2022 - Online webinar
This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.
The Role and Skills of a Valuable HR Assistant
7 Jul 2022 - 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)
A Practical Guide to Writing Risk Management Plans (RMPs)
11 Jul 2022 - Online webinar
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
Filing eCTD Submissions
11 Jul 2022 - London
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
Managing Vendor/CRO/CMO Oversight
11-12 Jul 2022 - London
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
Negotiating and Drafting IT Contracts
11-12 Jul 2022 - London
A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.
Presented by Mark Weston (bio)
Successful Medical Writing
11-13 Jul 2022 - London
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.
A Practical Guide to Producing and Maintaining the PSMF
12 Jul 2022 - 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)
Pharmacovigilance Aspects of Licensing Agreements
13 Jul 2022 - London
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
The Role of the Senior HR Manager
13-14 Jul 2022 - 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)
Pharmaceutical Development of ATMPs
13-14 Jul 2022 - London
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
SMART Packaging and Electronic Patient Information
13 Jul 2022 - London
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). These technologies have grown in importance providing patients and medical staff with product data, reminders, healthcare delivery and diagnostic tools.
Presented by Christopher Waterhouse (bio)
Clinical Trial Regulatory Requirements
14-15 Jul 2022 - 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 and key difference it compares with the Clinical Directive requirements.
Presented by Laura Brown (bio)
Stability Testing of Pharmaceuticals and Biopharmaceuticals
14-15 Jul 2022 - 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.
How to Avoid Common Pitfalls in Combined EU/US Patent Applications
18-19 Jul 2022 - Online webinar
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.
Effective Communication Skills for Managers
18-19 Jul 2022 - London
In the evolving workplace, effective management communication has never been more important, to not only help maintain productivity, but also to enhance team dynamics and improve staff retention. This interactive 2 day workshop will examine the key principles of communication and help you to identify your own communication style and develop techniques to improve your communication with others. The course will cover key elements of communications in management including, motivation, goal setting, delegating and giving feedback. We will also discuss one of the most under-rated communication skills: Listening
Presented by Susan Croft (bio)
Influencing, Persuading and Negotiating Skills for International Lawyers
25-26 Jul 2022 - London
A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*
Presented by Arun Singh OBE (bio)
August 2022 training courses
Drafting and Negotiating Clinical Trial Agreements
1 Aug 2022 - London
This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted
Presented by Alex Denoon (bio)
An Introduction to the Medical Device Regulation
1-3 Aug 2022 - 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.
Biological Evaluation of Medical Devices
1-2 Aug 2022 - 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
Drafting International Intellectual Property Agreements
8 Aug 2022 - London
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
8-9 Aug 2022 - 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)
Drafting International Commercial Agreements in English
8-10 Aug 2022 - London
The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.
Presented by Alan Simmons (bio)
Formal Requirements of the European Patent System
8-9 Aug 2022 - 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 Petra Schmitz (bio)
Medical Device Studies: Clinical Evidence
15-16 Aug 2022 - London
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
Presented by Janette Benaddi (bio)
Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
15-16 Aug 2022 - 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)
Virtual Management Skills
15 Aug 2022 - Online webinar
Every manager wants to lead a group of high performing, productive and motivated professionals, who in turn want good working relationships with colleagues, co-workers and managers. But how can this best be achieved when working virtually and online most of the time...?
Examine the ways to overcome challenges in virtual communication, supervision, inclusion and accountability. The programme will be based on recent research and latest best practice on how to lead, direct and interact with your team virtually, including freelance and overseas staff
Presented by Graham Roberts-Phelps (bio)
September 2022 training courses
5-day International Commercial Contracts School
5-9 Sep 2022 - Online webinar
This specialist five-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.
Presented by Arun Singh OBE (bio)
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
6-7 Sep 2022 - 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.
Managing Remote Teams
7 Sep 2022 - 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)
Ownership and Control of Intellectual Property Rights
7 Sep 2022 - Online webinar
In one intensive day learn how to protect and exploit your intellectual property rights for maximum commercial benefit
Presented by Mark Weston (bio)
Project Management for Pharma Professionals
8-9 Sep 2022 - 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)
EPO Oppositions and Appeals - the Case Law and Workshop
8-9 Sep 2022 - Online webinar
Updated for 2021! Drawing on case law and the experience of the faculty, this seminar considers the present workings of the opposition and appeal procedures at the European Patent Office. It provides an in-depth summary of both background and recent developments at the EPO and explains how these will impact on your day-to-day practice. It will give you the knowledge and skills to navigate this highly technical area.
Strategic IP Planning
12-14 Sep 2022 - Online webinar
A step-by-step practical guide to strategic IP planning
Presented by Arnaud Gasnier (bio)
Liabilities, Damages and other Contentious Issues in International Commercial Agreements
12-13 Sep 2022 - Online webinar
Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.
Presented by Arun Singh OBE (bio)
Running Virtual Meetings
12 Sep 2022 - Online webinar
This programme has been designed to help you learn how to prepare and construct a virtual meeting. You will explore the advantages and disadvantages of the various available platforms, understand how to ensure your virtual meeting is engaging and interactive, and practise delivering elements of a virtual meeting in an engaging and interactive manner.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
FDA Approval Process for Medical Devices
12-13 Sep 2022 - 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)
MBA Strategic Thinking for Pharma and Biopharma Professionals
12-13 Sep 2022 - 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)
Presenting Virtually
13 Sep 2022 - 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)
Metered Dose Inhaler (MDI) Technology
13-14 Sep 2022 - Online webinar
A comprehensive overview of MDIs including development, manufacture, regulation and market potential
Presented by David Howlett (bio)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
14-15 Sep 2022 - 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
15-16 Sep 2022 - 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.
Drafting International R&D Collaboration and Joint Venture Agreements
15 Sep 2022 - Online webinar
Ensure clear, structured, risk-free collaborative R&D and joint venture agreements for maximum commercial success in one intensive day.
Presented by Rebecca Attree (bio)
Effective Candidate Sourcing & Selection
15 Sep 2022 - Online webinar
This highly practical workshop provides a step-by-step approach to the recruitment and selection process, including the challenges of holding virtual interviews and online selection asssessments events. The course will cover techniques for advert writing, interview skills and selection tecniques, all to help you attract and select the right candidates. It is ideal for HR professionals and HR involved in staff recruitment
Presented by Graham Roberts-Phelps (bio)
An Essential Overview of the Pharmaceutical and Biotech Industries
16 Sep 2022 - 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)
The FDA Drug Approval Process
19-20 Sep 2022 - Online webinar
A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
19-20 Sep 2022 - 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)
Avoiding Pitfalls in Patent/Know-How Licences and R&D Collaborations
19 Sep 2022 - 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 Simon Portman (bio)
Best Practice for Writing Effective SOPs
19 Sep 2022 - London
An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.
Presented by Laura Brown (bio)
Pharmacovigilance
20-22 Sep 2022 - London
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 6 more leading experts
3-day Drafting Commercial Contracts
20-22 Sep 2022 - London
A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.
Presented by Mark Weston (bio)
CAPA (Corrective and Preventative Action)
20 Sep 2022 - London
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.
Presented by Laura Brown (bio)
Medical Device Regulations in the Middle East and North Africa
20-21 Sep 2022 - London
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 Role of an Effective HR Advisor
20-21 Sep 2022 - London
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)
Advanced Pharmacovigilance
21-23 Sep 2022 - 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)
Pre-Filled Syringes: End-to-End Processing
21-22 Sep 2022 - 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.
GCP and Clinical Research Update - Hot Inspection Topics
22 Sep 2022 - Online webinar
This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments
Presented by Laura Brown (bio)
Process Validation with Qualification
26-27 Sep 2022 - 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)
Regulatory Strategies for Orphan Drugs
26 Sep 2022 - Online webinar
This must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.
Presented by Marloes van der Geer (bio)
IP Due Diligence & Freedom to Operate in Practice
26-27 Sep 2022 - 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.
Presented by
Tim May (bio)
and 3 more leading experts
Business and Contract Law
26-27 Sep 2022 - London
A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.
Presented by Arun Singh OBE (bio)
Regulatory Affairs for Support Staff
27-28 Sep 2022 - 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 Regulatory Affairs for Medical Devices
27-28 Sep 2022 - Online webinar
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Biotechnology for the Non-Biotechnologist
28-30 Sep 2022 - London
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
Presented by
Adrian Haines (bio)
and 6 more leading experts
An Introduction to Pharmaceutical Packaging
28-29 Sep 2022 - 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)
Drug/Device and Device/Drug Combinations in the EU and USA
29-30 Sep 2022 - Online webinar
Practical guidance on borderline Issues and combination products
Presented by
Tina Amini (bio)
and 3 more leading experts
Agile Leadership for Pharma and Biopharma Professionals in a virtual world
29-30 Sep 2022 - 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 and Managing Competition Law Compliance
29 Sep 2022 - Online webinar
Learn how to navigate competition law and ensure compliance while maximising opportunities for your business
Presented by Rebecca Attree (bio)
Effective Technical Writing & Editing
30 Sep 2022 - 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)
October 2022 training courses
The Role and Skills of a Valuable HR Assistant
3 Oct 2022 - London
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)
A Practical Guide to Writing Risk Management Plans (RMPs)
3 Oct 2022 - London
Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
Presented by Graeme Ladds (bio)
Nasal Drug Delivery
4-5 Oct 2022 - London
A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.
Presented by
Michael Benninger (bio)
and 12 more leading experts
An Introduction to the Design and Development of Medical Devices
4-5 Oct 2022 - 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
4-7 Oct 2022 - Online webinar
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
A Practical Guide to Producing and Maintaining the PSMF
4 Oct 2022 - London
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)
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
5-6 Oct 2022 - 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)
Pharmaceutical Development of ATMPs
6-7 Oct 2022 - Online webinar
This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.
Managing the Intergenerational Workplace
6 Oct 2022 - Online webinar
This interactive webinar will look at what Leaders and Managers can to 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)
Data Integrity and Document Management
10 Oct 2022 - 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)
An Essential Overview of Pharmacovigilance
10 Oct 2022 - Online webinar
A practical guide to understanding the role of pharmacovigilance.
Presented by Graeme Ladds (bio)
Building Self-Belief & Resilience
10 Oct 2022 - 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)
Successful Medical Writing
11-13 Oct 2022 - 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.
Biosimilars
11-12 Oct 2022 - Online webinar
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
Presented by Marloes van der Geer (bio)
Effective Technology Transfer
11-12 Oct 2022 - Online webinar
The ‘how to’ of technology transfer across the product lifecycle
Presented by Bruce Davis (bio)
Medical Device Regulation in the Eurasian Union, Russia and the CIS
12-13 Oct 2022 - 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)
Employment Law in Practice from Recruitment to Termination
12-13 Oct 2022 - Online webinar
Raise your knowledge of the latest employment law and legislation and learn how to deal practically with the numerous issues an employer regularly faces.
Presented by Toni Trevett (bio)
Pharmaceutical Regulatory Affairs in Asia
12-14 Oct 2022 - 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
Variations to Marketing Authorisations
13-14 Oct 2022 - 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)
Freedom-to-Operate Searching
13 Oct 2022 - 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)
New Regulations for Medical Devices and IVDs in Europe
13-14 Oct 2022 - Online webinar
During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.
Risk Management for Pharma and Biopharma Professionals
14 Oct 2022 - 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)
Managing Vendor/CRO/CMO Oversight
17-18 Oct 2022 - Online webinar
Optimising oversight for inspection compliance
Presented by Laura Brown (bio)
Pharmacovigilance Aspects of Licensing Agreements
17 Oct 2022 - Online webinar
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
How to Avoid Discrimination, Victimisation, Harassment and Unconscious Bias in the Workplace
17 Oct 2022 - 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)
Effective Communication Skills for Managers
17-18 Oct 2022 - Online webinar
In the evolving workplace, effective management communication has never been more important, to not only help maintain productivity, but also to enhance team dynamics and improve staff retention. This interactive 2 day workshop will examine the key principles of communication and help you to identify your own communication style and develop techniques to improve your communication with others. The course will cover key elements of communications in management including, motivation, goal setting, delegating and giving feedback. We will also discuss one of the most under-rated communication skills: Listening
Presented by Susan Croft (bio)
Introduction to Veterinary Pharmacovigilance
18-19 Oct 2022 - 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)
EU Pharmaceutical Regulations & Strategy
18-19 Oct 2022 - Online webinar
The course will provide an up-to-date overview of the European pharmaceutical regulatory environment procedures and obligations.
The regulatory impact of post-Brexit changes on regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations in the UK will be discussed.
Presented by Norah Lightowler (bio)
Filing eCTD Submissions
19 Oct 2022 - 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 Writing for Medical Devices
19-20 Oct 2022 - Online webinar
How to produce quality regulatory documents including the clinical evaluation report (CER)
EU Clinical Trial Regulation 536/2014: Overview and Implementation
20-21 Oct 2022 - Online webinar
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU
Presented by Laura Brown (bio)
Practical Implementation of GCP in Veterinary Field Studies
20-21 Oct 2022 - 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.
Dealing With Difficult People
20 Oct 2022 - 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)
November 2022 training courses
Drafting Commercial Contracts
1-2 Nov 2022 - Online webinar
A practical and interactive two-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training of the key drafting skills.
Presented by Mark Weston (bio)
How to Improve Accuracy and Attention to Detail
1 Nov 2022 - 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)
The Mini MBA for In-house Lawyers
1-4 Nov 2022 - London
Business, commercial, financial and leadership skills to manage and develop a sound and strategically effective in-house legal department
The Role of the Senior HR Manager
1-2 Nov 2022 - London
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)
Effectively Managing Legal Risk and Preserving Reputation
1-2 Nov 2022 - London
This practical and interactive two-day programme will ensure you understand where your organisation is exposed and how you can successfully protect against risk.
An Essential Overview of the Medical Device Industry
2 Nov 2022 - 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.
SMART Packaging and Electronic Patient Information
2 Nov 2022 - London
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). These technologies have grown in importance providing patients and medical staff with product data, reminders, healthcare delivery and diagnostic tools.
Presented by Christopher Waterhouse (bio)
The New EU Animal Health Legislation for Veterinary Medicinal Products
3-4 Nov 2022 - Online webinar
The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.
Presented by Julian Braidwood (bio)
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
3-4 Nov 2022 - 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.
Recruiting a High Performance Global Workforce Within the Law
3-4 Nov 2022 - Online webinar
An intensive and practical two-day programme for HR professionals and line managers.
Raise your knowledge of the latest laws and best practice for recruiting overseas nationals and learn how to integrate them effectively into your current workforce.
Presented by Jocelyn Hughes (bio)
Drafting Effective Pharmaceutical Patents
3-4 Nov 2022 - Online webinar
*New for 2020!*
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.
Drafting and Negotiating Clinical Trial Agreements
4 Nov 2022 - Online webinar
This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted
Presented by Alex Denoon (bio)
Negotiating and Drafting IT Contracts
7-8 Nov 2022 - Online webinar
A two-day seminar designed to explain what IT contracts are, how and why they work and how to put them in place.
Presented by Mark Weston (bio)
Reviewing and Negotiating Technology Transfer and Licensing Agreements
7-8 Nov 2022 - Online webinar
Providing key legal and commercial skills essential to secure a successful agreement.
Presented by Michala Meiselles (bio)
Development of Combination Products: Critical Interactions
7-8 Nov 2022 - Online webinar
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
An Introduction to the Medical Device Regulation
8-10 Nov 2022 - 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.
Litigation-Proofing and Proving your Patent Claims
8 Nov 2022 - London
This seminar provides a comprehensive overview of the principles of patent claim interpretation in the USA, UK and Germany.
Clean Communication
9 Nov 2022 - 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)
The Pharma Mini MBA
9-11 Nov 2022 - 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
Presented by Laura Brown (bio)
How to Avoid Common Pitfalls in Combined EU/US Patent Applications
9-10 Nov 2022 - 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 Art of European Claim Drafting
10-11 Nov 2022 - Online webinar
This seminar combines one day of claim drafting fundamentals with a further day of focused workshops.
Advanced Drafting Techniques for Successful EPO Patent Applications
10 Nov 2022 - 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)
Effective Defence of EPO Patent Applications
11 Nov 2022 - 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)
Mental Resilience in a Home-working Environment
11 Nov 2022 - Online webinar
This programme will help you consider why a positive attitude is the key to home working and encourage you to develop disciplines for maximising the effectiveness of home working. You'll learn how to overcome issues of loneliness and isolation, develop coping strategies for maintaining self-confidence and self-worth and learn how to achieve and maintain a work/life balance when working remotely.
This is an interactive online course consisting of 2 x 90 minutes sessions.
Presented by Geoff Marsh (bio)
Drafting and Negotiating International Agency and Distribution Agreements
14-15 Nov 2022 - Online webinar
Proactively manage the legal and commercial considerations essential for securing a successful international agreement.
*INCLUDES: Practical and interactive exercises*
Presented by Michala Meiselles (bio)
Positive Persuading and Influencing Skills for Pharma Professionals
14-15 Nov 2022 - 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)
Medical Device Studies: Clinical Evidence
14-15 Nov 2022 - 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)
Developing High Performance HR Business Partner and Consulting Skills
15-16 Nov 2022 - 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)
Drafting International Commercial Agreements in English
15-17 Nov 2022 - Online webinar
The complete guide to drafting and negotiating clear and concise commercial agreements in English. Presented by expert linguists with extensive experience in commercial law.
Presented by Alan Simmons (bio)
Pharmacovigilance QMS & Inspection Preparation
16-17 Nov 2022 - Online webinar
This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
Presented by Graeme Ladds (bio)
Clinical Quality Management Systems
17-18 Nov 2022 - Online webinar
A two-day course that will ensure you comply with new regulatory requirements.
Presented by Laura Brown (bio)
Formal Requirements of the European Patent System
17-18 Nov 2022 - 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 Petra Schmitz (bio)
Influencing, Persuading and Negotiating Skills for International Lawyers
17-18 Nov 2022 - Online webinar
A two-day workshop for those who need to achieve results through personal influence.
*BOOK EARLY – limited places available!*
Presented by Arun Singh OBE (bio)
Drafting International Intellectual Property Agreements
18 Nov 2022 - Online webinar
Focus on the drafting skills and legal and commercial issues to be considered when drawing up international IP agreements.
Root Cause Analysis and Critical Thinking
21 Nov 2022 - 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)
Advanced Veterinary Pharmacovigilance
21-22 Nov 2022 - 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)
Business and Contract Law
21-22 Nov 2022 - Online webinar
A two-day no-nonsense plain English practical course* to get to grips with business and contract law for busy business executives.
Presented by Arun Singh OBE (bio)
Technical Documentation to Comply with the MDR and IVDR
22-23 Nov 2022 - Online webinar
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
Pharmaceutical Regulatory Affairs in China
22-23 Nov 2022 - Online webinar
A detailed overview of the key areas of pharmaceutical regulatory affairs in China, Hong Kong, Macau and Taiwan.
The Role and Responsibilities of the Contracts Manager
23-24 Nov 2022 - Online webinar
Getting from contract agreement to successful contract completion.
Proactively manage your contracts by applying a logical and systematic approach to enable you to anticipate risks and resolve problems before they become critical.
Presented by Catherine Hurst (bio)
Drafting Commercial Contracts for the Pharmaceutical Industry
23-25 Nov 2022 - Online webinar
A three-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues within the pharmaceutical, biotech and life sciences sectors.
Presented by
James Agnew (bio)
and 10 more leading experts
Liabilities, Damages and other Contentious Issues in International Commercial Agreements
23-24 Nov 2022 - London
Understanding the detailed law of damages and liabilities for the purposes of negotiating and drafting international contracts governed by English law.
Presented by Arun Singh OBE (bio)
Pharmaceutical Regulatory Affairs in Africa
23-24 Nov 2022 - Online webinar
Covering the key regions of South Africa, Namibia, Zimbabwe, Zambia, Malawi, Tanzania, Kenya, Uganda, Nigeria, Ghana and Maghreb countries - Algeria, Morocco, Tunisia
Virtual Management Skills
23 Nov 2022 - London
Every manager wants to lead a group of high performing, productive and motivated professionals, who in turn want good working relationships with colleagues, co-workers and managers. But how can this best be achieved when working virtually and online most of the time...?
Examine the ways to overcome challenges in virtual communication, supervision, inclusion and accountability. The programme will be based on recent research and latest best practice on how to lead, direct and interact with your team virtually, including freelance and overseas staff
Presented by Graham Roberts-Phelps (bio)
The Patent Administrator
24 Nov 2022 - Online webinar
This course will give you a comprehensive introduction to the role of the patent administrator
Presented by JoAnna Emery (bio)
Common Technical Document
28-29 Nov 2022 - Online webinar
A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
28-29 Nov 2022 - 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)
Signal Detection and Regulatory Expectations
29-30 Nov 2022 - 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)
December 2022 training courses
Borderlines between Medicines and Food
1 Dec 2022 - Online webinar
This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them
Effective Candidate Sourcing & Selection
1 Dec 2022 - London
This highly practical workshop provides a step-by-step approach to the recruitment and selection process, including the challenges of holding virtual interviews and online selection asssessments events. The course will cover techniques for advert writing, interview skills and selection tecniques, all to help you attract and select the right candidates. It is ideal for HR professionals and HR involved in staff recruitment
Presented by Graham Roberts-Phelps (bio)
The Medical Device School - From Concept to CE Marking
5-9 Dec 2022 - 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 Janette Benaddi (bio)
Working Through Veterinary Drug Development in the EU and USA
5-9 Dec 2022 - Online webinar
This practical five-day course provides a comprehensive understanding of veterinary medicine development in the EU and USA.
Presented by David Petrick (bio)
4-day International Commercial Contracts School
5-8 Dec 2022 - London
This specially designed four-day seminar has been expressly developed to focus exclusively on the law and regulations governing business and contract law for cross-border contracts.
Presented by Mark Weston (bio)
FDA Approval Process for Medical Devices
5-6 Dec 2022 - 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)
Human Factors and Usability Engineering in the Development of Drug Delivery Products
7-8 Dec 2022 - 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
7-9 Dec 2022 - 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)
Medical Device Regulations in the Middle East and North Africa
7-8 Dec 2022 - 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
IP Due Diligence & Freedom to Operate in Practice
7 Dec 2022 - 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.
Presented by
Tim May (bio)
and 3 more leading experts
Project Management for Pharma Professionals
8-9 Dec 2022 - 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)
Patent Protection for Software-Related Inventions in Europe and the USA
8 Dec 2022 - 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.
Best Practice for Writing Effective SOPs
12 Dec 2022 - 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)
3-day Drafting Commercial Contracts
12-14 Dec 2022 - Online webinar
A practical, interactive three-day programme designed to develop your skills to draft clear and concise commercial agreements. This comprehensive two-part programme focuses on delivering practical and applied training in the key drafting skills.
Presented by Mark Weston (bio)
Pharmaceutical Packaging, Labelling and Artwork Origination
12-13 Dec 2022 - Online webinar
This course has been designed to present a number of important developments in pharmaceutical packaging and labelling from regulations, standardisation and technology to innovation and artwork origination.
Presented by
George Barrie (bio)
and 6 more leading experts
Veterinary Pharmaceutical Submissions in the EU
13-14 Dec 2022 - Online webinar
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, detailed and critical summaries and regulatory submissions.
CAPA (Corrective and Preventative Action)
13 Dec 2022 - Online webinar
This course will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA.
Presented by Laura Brown (bio)
The Role of an Effective HR Advisor
13-14 Dec 2022 - 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)
Drug/Device and Device/Drug Combinations in the EU and USA
14-15 Dec 2022 - London
Practical guidance on borderline Issues and combination products
Presented by
Tina Amini (bio)
and 3 more leading experts
Effective Technical Writing & Editing
14 Dec 2022 - London
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)
Pharmacovigilance
14-16 Dec 2022 - 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 6 more leading experts
Pharmaceutical Regulatory Affairs in the Middle East
14-15 Dec 2022 - Online webinar
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen
US Patent Practice
15-16 Dec 2022 - 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