Veronika Jekerle European Medicines Agency

Veronika Jekerle obtained a pharmacy degree from University of Marburg, Germany (2001) and PhD in Molecular pharmacology, drug discovery from the University of Bonn, Germany and the University of Toronto, Canada. Since March 2020, Veronika is heading the Pharmaceutical Quality Office for Human Medicines at EMA and responsible for scientific oversight and management of the pharmaceutical quality of human medicines throughout their life-cycle in the context of the benefit risk assessment. She joined EMA in 2006 and held various positions including Product Team Lead for Biological medicinal product, Recombinant proteins, Vaccines, ATMPs and Biosimilar applications, Quality Specialist for Advanced Therapies, recombinant proteins including mABs, biosimilars and vaccines. She contributed to the implementation of the Regulation on Advanced Therapies and provided scientific support to development activities (i.e. ITF, scientific advice, PRIME, marketing authorisation and post-marketing procedures), coordinated EMA guidelines on Advanced Therapies (on gene and cell therapy), biologicals, vaccines and biosimilars. Between 2014 – 2020, she was Scientific Secretary to the Biologics Working Party (BWP), where she led initiatives for Biologicals including prior knowledge, innovative manufacturing for Biologicals and flexibility in CMC requirements for PRIME (and other early access approaches) and fostered close collaboration with FDA on these topics. In her role as Head of pharmaceutical quality, she co-lead the revision of the variation classification guideline and she is responsible for EMA’s Quality domain working parties, which include the BWP, the QWP, the Biosimilar working party and the Quality Innovation Group.