DUBLIN–(BUSINESS WIRE)–The “Clinical Trial Agreements: Key Legal, Regulatory and IP (Intellectual Property) Considerations for the EU (European Union) and UK Markets Training Course (Mar 18, 2026)” training has been added to ResearchAndMarkets.com’s offering.
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 short 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.
Benefits of attending
By attending this seminar 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 2024
- 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 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
- And CROs, sponsors and healthcare organisations looking to stay ahead in an evolving legal landscape.
Key Topics Covered:
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 trials
- 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:
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Participant consent and liability risks:
- Transparency obligations and the publication of clinical trials outcomes
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How transparency and consent interact with liability risks, including:
- Compensation models
- Clinical trials insurance
- Product liability risks for licensed products
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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)
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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
For more information about this training visit https://www.researchandmarkets.com/r/6n17d8
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