(MENAFN- GlobeNewsWire - Nasdaq) Navigating regulatory frameworks in the EU and UK offers significant opportunities in the life sciences sector by ensuring compliance, protecting IP, and managing risks. Mastering CTAs, understanding stakeholder roles, and managing liabilities can prevent disputes and enhance trial integrity.

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Clinical Trial Agreements: Key Legal, Regulatory and IP (Intellectual Property) Considerations for the EU (European Union) and UK Markets Training Course (Nov 28, 2025)" training has been added to ResearchAndMarkets'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

• 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:

• 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 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

Speakers:
Julia Kaufmann
Osborne Clarke
Julia Kaufmann, Partner, Osborne Clarke, advises both national and international companies on all legal matters relating to information technology, data licensing and data privacy law, cyber security, AI, ecommerce, marketing, and digital transformation. She focuses on the industry sectors Technology, Media and Communications as well as Life Sciences & Healthcare.
Julia has strong expertise with multi-jurisdictional privacy and data protection as well as ecommerce compliance projects. Furthermore, Julia has a focus on privacy law compliance and legal challenges with AI in the Life Science and Health Care Sector.
She has been assisting numerous multi-national companies with global data protection compliance programs, M&A-related privacy due diligence and integration, global digital marketing strategies, implementation of IT tools with AI components, investigations by data protection authorities, internal investigations, and legal requirements for the distribution of digital content and services.
Julia studied law in Munich at the Ludwig-Maximilians-Universität and obtained her LL.M. degree from the University of Texas at Austin, USA. She was admitted to the German bar in 2007 and to the New York bar as Attorney-at-Law in 2009. Before joining Osborne Clarke, Julia was a partner at an international law firm headquartered in the US.
She is named "Name of Next Generation" in data protection by Legal 500 in 2024 and ranked among "Best Lawyers" for data protection and "Best Lawyers" for information technology by Handelsblatt in cooperation with Best Lawyers in 2021 through 2024.
Roderick Dirkzwager
Covington & Burling LLP
Roderick Dirkzwager, Associate at Covington & Burling LLP, advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialisation of their is a member of Covington's Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.
Peter Rudd-Clarke
Osborne Clarke
Peter specialises in helping businesses navigate regulatory challenges and liability risks, particularly in the life sciences, healthcare and consumer products sectors.
Peter advises a range of businesses including medical device companies, software producers, pharmaceutical manufacturers, service providers and producers of lifestyle products.
His regulatory experience includes advising on the regulation of medical devices and consumer products, as well as CE/UKCA marking, clinical trials, regulatory investigations, the application of industry codes and ongoing compliance matters. The litigation and risk management side to Peter's practice involves defending manufacturers of complex products against liability claims, often across multiple jurisdictions; as well as advising clients on product recalls and corrective actions.
Peter is ranked in the Legal 500.
Sarah Cowlishaw
Partner
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.
Florian Reiling
Osborne Clarke
Dr Florian Reiling, MBA, has more than 10 years of experience in advising his clients in relation to all matters of intellectual property law. His main focus, however, lies on the commercialisation of IP rights in the Life Science & Healthcare sector.
Among his further key areas of expertise are R&D and collaboration agreements, the protection of AI-generated works (including the issues arising from the underlying legal frameworks), the protection of trade secrets, joint ventures and IP-related transactions.
Florian is an active member of the Life Science & Healthcare sector and has comprehensive experience in supporting clients from these industries in all contractual aspects involving the protection, the development and the commercialisation of IP Rights as well as regulatory issues.
Since many years, Florian is ranked in Legal 500, Best Lawyers, Handelsblatt and other directories for his work and experience in complex IP matters.
For more information about this training visit

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