Some of the topics to be covered at this meeting include an overview of the legal/policy landscape as it affects the terms of CTAs, clause-by-clause review, legal clauses, review of a University’s CTA
14 May 2019
& 5 Nov 2019
PLEASE NOTE: THE VENUE FOR THE MAY 2019 OUTING HAS NOW CHANGED TO THE REMBRANDT HOTEL
Clinical trial agreements are one of the most important agreements in the pharma industry as no research can start without the right agreement in place between sponsor and host organisation. They provide a contract which manages the relationship and responsibilities of both parties, and provide for the allocation of risk, obligations, the protection of academia, terms of collaboration, IP rights and much more.
This intensive one-day programme, delivered by experts in the field, will provide you with a full understanding of the importance of CTAs. It will describe how the regulatory environment affects them and explain the typical clauses which make up a CTA and what the key differences are between European and the US. By the end of this seminar you will be confident in spotting and addressing issues which arise when negotiating and drafting clinical trial agreements.
Overview of the legal/policy landscape as it affects the terms of CTAs
CASE STUDYNegotiating and drafting CTAs
Negotiating and drafting CTAs • Continued discussion of case study:
** Manufacture of the investigational medicinal product
** Warranties and indemnities
** Liabilities and insurance requirements
** Termination and its consequences
PRACTICAL EXERCISE – Negotiation
Arnold & Porter LLP is an international law firm with over 1000 lawyers across offices in the US, Belgium, China, Germany, and the UK. The EU life sciences team has unrivalled experience in advising on every aspect of the regulation of medicines, devices,cosmetics, foods and borderline products. The team includes a number of lawyers with scientific qualifications, including two physicians. It is regularly ranked as the leading firm providing regulatory advice and specialist litigation services to the life sciences sector.
Adela Williams is Partner in the life sciences group at Arnold & Porter. She advises clients in relation to the regulation of medicinal products in the UK and at the EU level. She also regularly advises on clinical trial issues and represents clients in product liability litigation arising from use of medicines in the research context.
Jackie Mulryne is Counsel in the life sciences group at Arnold & Porter. She has a broad practice providing regulatory compliance and public policy advice, and has extensive experience advising commercial clients on clinical trial agreements, both within and outside the NHS, and variations across the EU.
Ewan Townsend is Counsel in Arnold & Porter’s London office and assists clients in the life sciences sector on regulatory and commercial matters. He has experience with a broad range of regulatory issues that arise throughout the medicinal product and medical device life cycle, including research and development, clinical trials, marketing authorisations, manufacturing, distribution, advertising, pricing and reimbursement. Ewan’s work also includes drafting and negotiating commercial agreements for his life sciences clients, such as licence agreements, manufacturing, distribution and supply agreements, clinical trial agreements and service agreements, and advising on the intellectual property and regulatory issues that arise in the context of those transactions.
This course qualifies for the following CPD programmes: