Veronika Jekerle

Veronika Jekerle obtained a pharmacy degree from University of Marburg, Germany and a PhD in molecular pharmacology, drug discovery from the University of Bonn, Germany in 2006 (funded by the DFG (Deutsche Forschungs Gemeinschaft) and Government of Canada Award from the University of Toronto, Canada.

She joined the European Medicines Agency in London in March 2006, in Pharmacovigilance, Regulatory Affairs and since May 2007 in the Pre-authorisation Unit, Quality of Medicines Sector, where she worked as Product Team Leader for Biological Medicinal Products Applications including recombinant proteins, vaccines, ATMPs and biosimilar applications. In 2014, she became Quality Specialist in Specialised Scientific Disciplines Department with specialisation in Advanced Therapies, recombinant proteins including mABs, biosimilars and vaccines, where she contributes with specialised scientific input to various procedures including ITF, scientific advice, PRIME, marketing authorisation and post-marketing procedures. She has coordinated the development of several guidelines on Advanced Therapies, Recombinant Proteins and Biosimilars, most recently was the revision of the guideline for genetically modified cells. At EMA, she has led a number of important initiatives for Biologicals including prior knowledge and quality support to early access approaches. From 2009 to 2012, she was in charge of the Cell Products Working Party (CPWP) and since 2014, she is the Scientific Secretary to the Biologics Working Party (BWP). Since March 2020, she is the Head of Pharmaceutical Quality Office, Quality and Safety Department within the Human Division.