Copenhagen Centre for Regulatory Science
10, Building: 10.2.268B.
2100 København Ø
Marie Louise (Marieke) 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.
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.
The Copenhagen Centre for Regulatory Science (CORS) aims at being the international partner for academic leadership in regulatory science, research and education and to participate in building the regulatory framework that will make innovative medicinal products available to patients.
Marie Louise (Marieke) De Bruin was trained as a pharmacist (Utrecht University) and epidemiologist (Erasmus University Rotterdam) and has combined academic research with working for the regulatory authorities, both nationally (Pharmacovigilance expert for the Dutch Medicines Evaluation Board 2008-2016) and internationally (European Commission appointed independent Scientific Expert of the Pharmacovigilance Risk Assessment Committee (PRAC), at the European Medicines Agency 2012-2018). She has a strong background in epidemiology, is member of the steering group of the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP 2017-2019) and has applied quantitative methods from epidemiology to study regulatory science research questions. Working as a regulator has given her theoretical training about and hands-on experience in the functioning of the regulatory system. She has wide experience in coordination and execution of public-private as well as academic research collaborations, nationally, at EU level and globally.
Her personal motivation to engage in this field of research is to benefit public health and originates from her training as a health care professional. With her research, she wants to improve the drug regulatory system, by systematically studying its structure and behaviour as well as designing new tools to facilitate regulatory decision-making. Through improvement of the drug regulatory system, she aims to contribute to an improvement of the health of the society.