Falconbury Logo
Presented by
Falconbury

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

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

24 November 2026 »
from £350

Need help? Enrol/reserve

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.

Enrol/reserve

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

Enrol/reserve

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

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate
40% off the 3rd delegate
50% off the 4th delegate

Please contact us for pricing if you are interested in booking 5 or more delegates

24 November 2026

Live online

13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 16624

GBP 350 400
EUR 490 560
USD 562 640

Until 20 Oct

3 hours of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.