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.
*Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Overview of the legal/policy landscape as it affects the terms of CTAs
- What is a clinical trial?
- EU regulatory framework: What are the key regulatory considerations relevant to conducting a clinical trial?
- Introduction to the parties to the CTA and key roles and responsibilities
- Policy issues in public hospitals, e.g. UK NHS approval
- Other ethical/legal issues
- Standard contracts, e.g. NHS standard CTA
- Implications of Brexit
Negotiating and drafting CTAs
- Overview of issues that frequently come up in the negotiation/drafting of CTAs
- Introduction to case study
- Discussion of case study
- Intellectual property and publication provisions
- Use of data generated during the trial
- Data protection, medical records, freedom of information, etc
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
- Introduction to differences between US, UK and Continental European legal systems and how they may affect contract drafting
- Unlicensed product vs off-label use
- First-in-man studies
- Investigator initiated studies
- Compliance and anti-corruption issues
PRACTICAL EXERCISE - Negotiation
Adela Williams is Partner in the life sciences group at Arnold & Porter Kaye Scholer LLP, and advises clients in relation to the regulation of medicinal products in the UK and at the EU level. She 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 Kaye Scholer LLP. 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 a Senior Associate in Arnold & Porter Kaye Scholer’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.
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