Marie L De Bruin is professor in Regulatory Science at the Faculty of Health and Medical Sciences of the University of Copenhagen and director of the Copenhagen Centre for Regulatory Science (CORS) at the Department of Pharmacy (http://pharmacy.ku.dk/research/cors). Her research focusses on developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medical products in order to assess benefit-risk and facilitate a sound and transparent regulatory decision making. She is an affiliate professor at the Utrecht University, WHO collabolating centre for pharmaceutical policy and regulation (http://www.pharmaceuticalpolicy.nl). Marie L De Bruin was trained as a pharmacist and epidemiologist and has combined academic research with working for the regulatory authorities.