National Institute for Health and Care Excellence, UK
Francois Maignen, M.Sc.
Francois Maignen is a principal scientific adviser for the National Institute for Health and Care Excellence (NICE) in the UK. He advises companies on the clinical development of new technologies in various therapeutic areas (oncology, cardiovascular, neurology and orphan diseases) including main efficacy studies, clinical trials design, population selection, choice of endpoints and comparators, statistical issues and evidence generation for cost-effectiveness evaluations.
He previously worked at the European Medicines Agency (EMA) for 15 years and the Office of Health Economics. He gained extensive experience in clinical safety, registration and regulation of oncology and cardiovascular medicines in the European Union (EU) and an extensive knowledge of EU legislation. He was directly involved in the implementation of EudraVigilance and managed the Europe, Middle East and Africa (EMEA) EV team for 5 years.
He contributed to international harmonisation activities with the Council for International Organizations of Medical Sciences. His work on the exchange of information on signals between regulatory authorities was the stepping stone of the principles of signal management in the new pharmacovigilance legislation.
Some of his safety signals led to major world-wide regulatory decisions. As a statistician, he conducted studies on the statistical aspects of signal detection in the PROTECT IMI public private partnership research project.
He is a pharmacist and statistician by training and specializes in pharmacology and public health. He has developed an extensive network and excellent working relationships with professionals from regulatory authorities, academia, industry and contract research organisations.