Drafting and Negotiating Clinical Trial Agreements

The life science sector is heavily regulated and CTAs are some of the most important agreements for companies operating in this sector. Having appropriate CTAs in place is therefore essential for managing relationships between the different stakeholders, and apportioning risk and responsibilities between them. If appropriate contractual arrangements are not in place, a clinical trial may not receive approval or issues may arise with the integrity or validity of the data collected. Further, disputes between the parties can arise if responsibilities are not clearly defined in the agreement.

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. Participants will receive an overview of the legal framework regulating clinical trials in the European Union (and UK), before taking a closer, comprehensive look at specific issues that must be considered when drafting a CTA. Using a case study, participants will also look at some example clauses and will have the opportunity to practise negotiation skills in the safe environment of the course room under the guidance of our expert faculty.

By the end of the programme, you will be more confident in spotting and addressing the key issues that arise when negotiating and drafting CTAs, understand how best to mitigate against the risks and deal with them effectively when they do arise.

Key topics covered in this intensive and interactive seminar:

• An overview of the legal, ethical and policy considerations that underpin the conduct clinical trials as these affect how the terms of clinical trials agreements are drafted
• Recognising and dealing with key commercial and regulatory issues (including in particular relating to Brexit and the “flexibilities” adopted during the pandemic) that arise when drafting clinical trials agreements
• Drafting and negotiating techniques to minimise disputes and maximise efficiency

Attending this seminar will enable you to:

• Understand the legal framework concerning clinical trials in the EU and the UK
• Recognise and address the issues that arise when drafting and negotiating CTAs
• Gain a better understanding of the commercial and regulatory issues that affect CTAs
• Consider the issues through the differing perspectives of sponsors and health care organisations