Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. Prior BfArM 10 years experiences as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. PostDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC). Ph.D. in pharmacology and licenced pharmacist.

In 1980 Jan Willem van der Laan joint the National Institute for Public Health and the Environment (RIVM, Bilthoven) as a biochemist and pharmacologist on CNS targets. In 1990 is he assessor Pharmacology and Toxicology of Human Pharmaceuticals at the and later, since 2011 directly for the Medicines Evaluation Board, located in Utrecht, the Netherlands. He is chair of the EMA/CHMP Safety Working Party since 2012. His contributions to the International Council on Harmonization started in 1993 on Carcinogenicity Testing. In 2012 the discussions on this topic have been restarted to reduce the number of 2-yr studies in rodents, and Jan Willem is Regulatory Chair on this process.

Dr Ulla Wändel Liminga is a pharmacist, and has a Doctoral thesis in Medical Sciences from Uppsala University in Sweden. In 1994, she started at the Medical Products Agency (MPA), Sweden, as a non-clinical assessor. She has since then worked with non-clinical as well as clinical efficacy and safety assessments. In 2007, she became Scientific director pharmacology and toxicology at the MPA, and in March 2020, her position has changed to Scientific director pharmacovigilance. From July 2012, she has been one of the Swedish members of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency.