Fabien Roy's practice focuses on European Union (EU) and national regulatory matters involving pharmaceutical, and medical device laws and guidelines. He has developed close contact with relevant government authorities in these sectors. Fabien is a keen writer and regularly publishes articles concerning developmentsin the medical device and pharmaceutical sectors. He is also a regular speaker at dedicated conferences.Fabien focuses particularly on the different stages of the medical device CE marking process. He advises on a wide variety of topics which include thefollowing: determination of the appropriate classification of individual products; clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data); drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements; clinical evaluation; conformity
Page 4of 11assessment procedure; review of Instruction For Use, products' labelling and promotional material including websites; post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal; reimbursement. Fabien also advises on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector.Fabien joined Hogan Lovells International in 2007 (at that time Hogan & Hartson LLP). He was called to the Brussels Bar in early 2011.