Sonja Beken


Dr. Sonja BekenSonja Beken obtained her Master in Biological Sciences at the Vrije Universiteit Brussel (VUB), Belgium, holds a PhD in Pharmaceutical Sciences (VUB) and a Master in Applied Toxicology from the University of Surrey, UK.
Sonja Beken is the Head of the Unit of non-clinical evaluators within the Belgian Federal Agency for Medicines and Health Products (FAMHP).  This Unit is responsible for the evaluation of non-clinical data (pharmacology, pharmacokinetics and toxicology) submitted to support all phases of the life cycle of drug development (e.g. marketing authorization applications, clinical trial applications, EU and national scientific advice, paediatric investigation plans, etc).
She is Vice-Chair of the Safety Working Party (SWP), Chair of the CVMP/CHMP Joint Ad Hoc Expert Group on 3R’s (JEG 3Rs), both at the European Medicines Agency (EMA) and she is Group Leader of the Informal S5(R3) Working Group at the level of the International Conference on Harmonisation (ICH). In June 2014 she was elected as Member of the Board Of Trustees of HESI (Health and Environmental Sciences Institute, US).
Her main areas of expertise relate to regulatory science, non-clinical drug development, (in vitro) toxicology and metabolism as well as alternative models to animal experiments (3Rs).