Expert 3R’s in pharmaceutical industry (Belgium)


Sonja Beken holds a Master in Biological Sciences followed by a PhD in Pharmaceutical Sciences and a Master in Applied Toxicology thus ensuring in depth training in all aspects of non-clinical testing.

  • She joined the Belgian Federal Agency for Medicines and Health Products (FAMHP) to work as a non-clinical reviewer in 2001. She developed the expertise related to non-clinical testing of human pharmaceutical within the FAMPH and currently heads a mature team of 9 non-clinical reviewers. Over the years she produced more than 250 non-clinical assessment reports for new and existing medicinal products in national and European procedures encompassing the complete life cycle of a medicinal product, namely scientific advice, clinical trial applications, marketing authorisation applications and non-clinical follow-up of pharmacovigilance safety signals. The close collaboration with her team members – who themselves are or have been members of key committees and working parties at the European Medicines Agency (EMA) (e.g. CHMP, PDCO, CAT, BMWP, VWP, Nanomedicines drafting group, PDCO Non-clinical working group, SAWP) – has enabled her to achieve continuous knowledge building and exchange related to ongoing activities at these different fora.
  • Sonja Beken joined the EMA Safety Working Party (SWP) as Belgian member in 2001, and in that function has been actively contributing to the drafting process of new guidelines or the revision of existing guidelines, peer review of scientific advices and she also presented specific topics at different Preclinical Assessor Trainings. As such she was/is rapporteur for the Concept paper on the Need for Revision of the Position on the Replacement of Animal Studies by in vitro Models (EMA/CHMP/SWP/169839/2011), the draft Guideline for Regulatory Acceptance of 3R Testing Paradigms and also co-author for the Reflection Paper: Detection of Early Signals of Hepatotoxicity from Non-Clinical Data (CHMP/SWP/150115/06).
  • In 2013, Sonja Beken was appointed as vice-chair of SWP, and is now actively assisting the chair to ensure successful accomplishment of the current tasks and contributing to the proactive identification and tackling of future SWP tasks. She acts as a facilitator and motivator to encourage active contribution to the discussions and the tasks ahead by the different SWP members and experts who represent a wealth of extensive expertise. She strongly supports the combination of multidisciplinary expertise and constructive discussions and collaboration as a lever to lift the non-clinical testing paradigms to a new level and thereby improve regulatory decision making.
  • In June 2014 she was appointed ICH Rapporteur for the revision of the ICH S5(R2) Guideline, a position for which up to now she has demonstrated strong leadership to achieve progress in a difficult area requiring major consensus building between major international stakeholders.
  • Over the years, Sonja Beken has been actively contributing to the evolution towards novel mechanistically based testing strategies which do not only aim for more predictive safety assessment but also strive towards more rational use of experimental animals through the implementation of the 3Rs (replacement, reduction and refinement and animal use) as requested per EU Directive 2010/63/EU. As such she very actively participates to large-scale international initiatives for example in the field of embryofetal development testing (ILSI HESI DART 2nd species steering team), microsampling for toxicokinetic testing (NC3Rs, UK), and on the use of human (stem) cell and tissue-based systems (NC3Rs UK, AIMBE & NIH US).
  • She was elected chair of the newly created EMA JEG 3Rs (Joint CVMP/CHMP ad hoc expert group on 3Rs) in June 2011 and in that function can contribute directly to the direct identification of opportunities for implementation of 3R testing paradigms that will lead to better predictive non-clinical safety and efficacy assessments for human and veterinary pharmaceuticals.