Katherine M. Llewellyn

Katherine Llewellyn counsels international clients on a wide range of EU regulatory matters. Her practice focuses on life sciences, particularly the biotechnology, pharmaceutical, medical device, cosmetics, and food sectors. She also advises clients in general EU product regulation. Katherine's dual qualifications in law and genetics provide clients with a unique and comprehensive perspective on issues they may face.

In the pharmaceutical sector, Katherine advises on matters involving the full life-cycle of medicinal products, from clinical trial related issues to post-market issues such as promotion and sector-specific data privacy matters. Her experience includes coordinating clinical trial contracting exercises across Europe, advising on pharmacovigilance and incident reporting, advising in connection with regulatory enforcement actions, and assisting various trade associations in connection with revisions of the EU regulatory framework with a view to shaping EU legislation affecting the sector. In addition, she has been involved in numerous M&A transactions providing EU regulatory support. [1]