Sonja Beken, PhD

Belgian Federal Agency for Medicines and Health Products (FAMHP), Bruxelles, Belgium


Sonja Beken holds a Master in Biological Sciences and PhD in Pharmaceutical Sciences from the Vrije Universiteit Brussel (VUB), Belgium and a Master in Applied Toxicology from the University of Surrey, UK. Sonja Beken is the Coordinator of the Unit of non-clinical evaluators at the Belgian Federal Agency for Medicines and Health Products (FAMHP). This Unit is responsible for the evaluation of non-clinical data submitted to support all phases of drug development (e.g. marketing authorizations, clinical trials, EU/national scientific advice, etc).

She is Member of the Safety Working Party (Vice-Chair 2013-2016) and of the CVMP/CHMP Joint 3Rs Working Group (Chair 2011-2016) at the European Medicines Agency (EMA). She was the ICH Rapporteur for the revision of the S5(R2) Guideline (2014-2016).

Over the years, Sonja Beken has contributed to the direct identification of opportunities for regulatory implementation of 3R testing paradigms through her active involvement in large-scale international initiatives (EPAA, CAAT, ILSI HESI, NC3Rs, AIMBE & NIH, etc). 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).