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

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.

Peter Rudd-Clarke 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.

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. 

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.

In 2022, Julia was named as one of only three German women in the second edition of Women in Data. Women in Data focuses on women who are at the forefront of legislation, regulation and technology.

In addition, Julia has been named one of 565 BTI Client Service All-Stars 2022, where clients identify lawyers who stand above all the others in delivering the absolute best in client service.

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 products. Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

• EU, Irish, and UK regulatory issues relating to pharmaceutical products and medical devices;
• commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
• regulatory and commercial due diligence for life sciences transactions; and
• intellectual property issues arising in corporate transactions and IP-related contracts.

Roderick is also a member of Covington's Life Sciences in Africa team and advises clients on regulatory and commercial strategies for the supply of medical products across Africa, including through international recognition procedures such as WHO pre-qualification. Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.