UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
Arnold & Porter is an international law firm at the intersection of business, law and regulatory policy, serving clients whose business needs require expert US and/or European cross-border regulatory, litiga- tion and transactional services. The firm has a par- ticularly high reputation for advising on UK and EU law relating to pharmaceuticals, biotechnology and
healthcare products and medical devices, and for as- sisting clients in interpreting and complying with the regulatory framework that surrounds these products. The authors would like to acknowledge the contribu- tions of Christopher Bates, Katya Farkas, Emma El- liston, Sofia Holmquist and Heba Jalil.
Authors
Adela Williams is a partner at Arnold & Porter, specialising in life sciences regulatory matters and litigation. She advises clients across the range of regulations impacting medicines including clinical trials, marketing
Libby Amos-Stone is a partner at Arnold & Porter and an experienced litigator specialising in regulatory and product liability matters in the firm’s life sciences practice group. Libby provides regulatory and compliance advice to clients in the pharmaceutical, medical technology, food and cosmetics sectors. She assists companies on strategic issues arising during the life cycle of pharmaceutical products including, clinical trials, classifications, regulatory data protection, paediatric and orphan rewards, market access, and investigations. She also advises companies on the boundaries of the legislation and codes of practice regarding the promotion of medicinal products and medical devices and represents clients in response to PMCPA complaints.
authorisations and rewards, and post authorisation matters such as pharmacovigilance and advertising as well as borderline issues and regulation of medical devices, cosmetics and foods. She has particular experience in the pricing and reimbursement of medicinal products and medical devices. Adela also acts for clients in disputes arising from regulatory decisions, and represents pharmaceutical and medical device clients in product liability litigation.
Ewan Townsend is a partner at Arnold & Porter who specialises in transactional and regulatory work in the life sciences sector. He has experience in drafting and negotiating a wide range of complex, high-value
Eleri Abreo is a life sciences regulatory lawyer and litigator with broad experience across the medical devices, in vitro diagnostics, pharmaceuticals, tissues and cells, blood products, foods, and cosmetics
agreements, such as licences and collaboration agreements, manufacture and supply agreements, technology transfers and clinical trial agreements. He is uniquely placed in his ability to advise on the regulatory issues that arise in the context of those transactions, particularly in relation to marketing authorisations, manufacturing and distribution, pricing, advertising and promotion, freedom of information and data protection.
sectors. She has particular expertise in MedTech, advising on the full spectrum of medical devices, IVDs, digital health technologies, AI and software as medical devices, and complex combination or advanced products. Eleri supports clients throughout the product lifecycle, from development, classification, and clinical or performance evidence, to market access, supply chains, and regulatory engagement across the EU and UK. She also has significant experience in complex product liability litigation.
386 CHAMBERS.COM
Powered by FlippingBook