Sarah Faircliffe is a legal director in Bird & Bird’s International Life Sciences Group based in London.
Sarah specialises in European regulatory law, with a focus on medicinal products. She has a wealth of industry knowledge and a unique insight into the law and procedures concerning the regulation of medicines, having spent 10 years as Legal Adviser with the European Medicines Agency (EMA). During her time at the EMA she advised on a wide range of regulatory topics, including orphan drugs, paediatrics and generics of centrally authorised products. She played a key role in the project to help the newest EU member states, joining in 2004, ensure that their national pharma legislation and procedures were in line with the EU requirements, and was closely involved in the drafting and implementation of many aspects of the revised pharmaceutical legislation. She also worked closely with the European Commission on a number of pieces of litigation involving the EMA / European Commission, the drafting and implementation of the Paediatrics Regulation and the early stages of the Advanced Therapies legislation. She was a regular participant and speaker in workshops with various industry and patient groups as well as with national regulatory agencies and ministries.
Sarah also has exposure to the workings of other European regulatory agencies, such as the European Food Safety Authority and has a particular interest in the various categories of borderline products such as nutraceuticals and cosmeceuticals.