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Falconbury

Clinical Trial Agreements: Key Legal, Regulatory and IP (Intellectual Property) Considerations for the EU (European Union) and UK Markets In-house Training

Essential training course for lawyers, contract managers, and clinical professionals covering liability risks, transparency obligations, and IP protection in clinical trial agreements (CTAs).

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Course overview

The life sciences 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 training course provides essential insights into the legal framework governing clinical trials in the EU and UK, ensuring compliance, protecting intellectual property and managing liability risks.

The expert speakers will explain the dynamic and increasingly demanding regulatory and data protection landscape to better inform those negotiations and drafting these agreements.

This training course is part of our Commercial Contracts Training Course collection which has been designed for the in-house lawyer.

Benefits of attending

By attending this training course you will:

  • Learn about the regulatory framework concerning clinical trials in the EU and the UK
  • Understand the EU Clinical Trial Regulation and UK Human Use (Clinical Trials) (Amendment) Regulations 2025
  • Examine the roles and obligations of stakeholders including sponsors, CROs, investigators, and ethics committees
  • Navigate clinical trials approval, ethical approvals, policy issues, and the legal risks of non-compliance
  • Master informed consent, clinical trial transparency, and compensation models to mitigate legal exposure
  • Learn how to protect IP rights in clinical trials, draft strong confidentiality agreements, and manage publication clauses.

 

Who should attend?

This training course has been specially designed for:

  • Lawyers and in-house legal teams
  • Contract managers
  • Clinical contract specialists
  • Clinical trial managers and professionals
  • R&D staff
  • Regulatory specialists
  • IP lawyers and professionals

And CROs, sponsors and healthcare organisations looking to stay ahead in an evolving legal landscape.

This course will cover:

Overview of the regulation of clinical trials – the legal framework governing clinical trials in the EU and the UK

  • What a clinical trial is and the types of clinical trial
  • Who the stakeholders are and their roles and obligations 
  • EU regulatory framework under the Clinical Trial Regulation 536/2014/EU and the Clinical Trials Information System (CTIS)
  • UK framework post Brexit under the Human Use (Clinical Trials) (Amendment) Regulations 2024
  • Clinical trial approval, ethics approval and policy issues (eg Health Research Authority approval)
  • What could happen if a clinical trial is not conducted in accordance with the law

Consent, data and IP rights

Sponsors and CROs must meet obligations relating to transparency, participant consent and data protection in clinical trials. In turn, those obligations have an impact on parties' liability risks and IP rights. This session will examine:

  • Participant consent and liability risks:
    • Transparency obligations and the publication of clinical trials outcomes
    • How transparency and consent interact with liability risks, including:
      • Compensation models
      • Clinical trials insurance
      • Product liability risks for licensed products 
  • Data protection:
    • Overview of the requirements
    • Use of patient data during and after a clinical trial (particularly in light of the 3/2019 guidance from the European Data Protection Board)
  • Intellectual property rights:
    • Relevant IP rights associated with clinical trials
    • How to best protect any accruing IP rights
    • Drafting and negotiating of IP rights, confidentiality and publication clauses

Final questions

2 Jul 2026
24 Nov 2026

Sarah Cowlishaw
Covington & Burling LLP

Sarah Cowlishaw is a Partner at Covington & Burling LLP. She advises clients on a broad range of life sciences matters. She supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences law. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

More details

2 Jul 2026
24 Nov 2026

Robin Blaney
Covington & Burling

Robin Blaney is a partner in Covington & Burling’s Life Sciences practice. He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector. His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements and tenders. He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions.

More details

2 Jul 2026

Mario Subramaniam
Bird & Bird

Mario is a partner at Bird & Bird and an IP and transactions specialist with extensive experience in the Life Sciences. He advises global Life Science clients on strategic IP licensing, collaboration and partnering transactions. He also supports those clients with M&A, joint ventures, asset acquisitions and disposals, strategic manufacturing, supply and outsourcing arrangements. Prior to qualifying as a solicitor, Mario worked as a research scientist in the fields of tumour immunology and molecular biology. Having spent a significant period of his career in-house advising Life Science clients, Mario brings a wealth of experience and a unique perspective to clients contemplating strategic transactions and partnerships. His experience and approach also brings great synergy to Bird & Bird's outstanding Life Sciences offerings, allowing an unrivalled opportunity to support clients with their most pressing challenges.

More details

United Kingdom

  • London School of Hygiene and Tropical Medicine
  • NHS National Services Scotland
  • Simbec Orion
  • Simbec-Orion
  • The University of Nottingham
  • University of Nottingham

Switzerland

  • Idorsia Pharmaceuticals Ltd
  • Unemployed

France

  • Lesaffre International

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to our team to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Harry Altamont

Harry
ALTAMONT

Aleksandra Beer

Aleksandra
BEER

+44 (0)20 7749 4749

inhouse@ipiacademy.com