Sarah Faircliffe

Legal Director at Bird & Bird

Speaker

Sarah is a Legal Director in Bird & Bird's London office. As a member of the International Life Sciences Group, she specialises in European regulatory law concerning medicinal products, medical devices and related areas.

Sarah spent 10 years as a Legal Adviser with the European Medicines Agency (EMA); during this time, she covered many areas, including orphan drugs, paediatrics and generics of centrally authorised products, as well as advising the EMA's scientific committees on various legal issues. She played a key role in the project to ensure that the new EU member states joining in 2004 brought their pharma legislation and procedures into line with EU requirements. Working closely with the European Commission, she assisted with a number of pieces of litigation and the drafting and implementation of various pieces of legislation. Sarah also has experience of the workings of other key EU regulators including the European Food Safety Authority, and takes a particular interest in borderline products such as nutraceuticals and cosmeceuticals.

Since joining Bird & Bird, Sarah has used her in-depth knowledge of the regulatory framework to assist a wide range of clients on all aspects of the regulation of products in the life sciences sector. This ranges from advising on the correct interpretation of legislation, guidelines and case law to helping to steer clients through procedures and negotiations relating to the marketing of their products, including representing them in discussions with regulatory bodies. Much of this work involves working closely with Bird & Bird colleagues in other offices to provide pan-European regulatory advice. Strategies and disputes concerning regulatory data protection and orphan exclusivity are a particular focus of her current work.

Sarah is a regular speaker at conferences and workshops and contributes to a number of publications. She also co-chairs Bird & Bird's Life Sciences Regulatory Group.