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.
CPD Hours: 3
Course Content
- Day 1
- Overview of the regulation of clinical trials - the legal framework governing clinical trials in the EU and the UK
- Consent, data and IP rights
- Final questions
Speakers
Sarah Cowlishaw
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.
Robin Blaney
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.
