The Netherlands Area Biotech Discussion Group
June 13, 2023
The Role of EMA’s Pharmaceutical Quality Office in the Approval of Medicines for Human Use | 13 June 2023 15:30 - 18:00 CET
Featured Speaker:
Veronika Jekerle, European Medicines Agency (EMA)
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.
She joined the European Medicines Agency in 2006 initially in post-authorisation & pharmacovigilance, regulatory affairs and pre-authorization. She has been a Product Team Lead for various biological medicinal product applications including recombinant proteins, vaccines, ATMPs and biosimilars. In 2014 she became Quality Specialist with specialization in Advanced Therapies, recombinant proteins including mABs, biosimilars and vaccines. She contributed to the implementation of the new Regulation on Advanced Therapies with scientific support to development and marketing authorization activities (i.e. ITF, scientific advice, PRIME, marketing authorization and post-marketing procedures) and coordinated important guidelines on Advanced Therapies (on gene and cell therapy). 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. 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.