Birka Lehmann

Paediatric development, Ex-Regulator

Dr Birka Lehmann had been Head of Executive Department EU and International Affairs of the Federal Institute for Drugs and Medical Devices (BfArM). She had been a member of the Paediatric Committee at the European Medicines Agency (PDCO) till end of 2015.

Birka Lehmann studied Medicines at the Free University Berlin and trained at the Kinderklinik Norderney. She worked in the area of preclinical assessment in the division “Pharmacology and Toxicology” of BfArM, as head of unit “Decentralised Procedure”, as deputy head of EU Division, and as head of the division 3 “Marketing Authorisation procedure” at the BfArM. For several years, she joined the European Commission, Directorate-General Enterprise and Industry, as expert on secondment to in the unit ‘Pharmaceuticals’ responsible for inter alia Marketing Authorisation and implementation of Clinical Trials Directive..

Since 1999, she is lecturer at the University Bonn for “Drug Regulatory Affairs”, she had also been lecturer at the University Duisburg/Essen and University Kopenhagen (Medicademy).