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 that 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 that arise when negotiating and drafting clinical trial agreements.
Why should you attend?
- This seminar will enable you to:
- Recognise and address the issues that arise when drafting and negotiating clinical trial agreements
- Gain a better understanding of the legal, contractual and practical issues that affect clinical trial agreements
- Consider the issues through the differing perspectives of sponsors and health care organisations
- Complete practical exercises on drafting and negotiating to consolidate your learning
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. 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.
DoubleTree by Hilton London-West End
92 Southampton Row
Just a two minute walk from Holborn Station (Piccadilly and Central lines) and a five minute walk to Russell Square Station (Piccadilly line)
Euston station is the closest National Rail Station – however the hotel is accessible from all London Stations via the underground
There is no parking available at the hotel, however there is an NCP car park located 5 minutes away (walking distance) from the hotel at the following address:
Bloomsbury Square, Bloomsbury, London, WC1A 2RL
This car park is charged at £20 for 24 hours