Dr Birka Lehmann is Senior Expert for Drug Regulatory Affairs and Lecturer at the University of Bonn since 1998.

Birka Lehmann studied Medicines at the Free University Berlin and trained at the Kinderklinik Norderney. Her working experience includes 9 years preclinical assessment in the division ‘Pharmacology and Toxicology’ of BfArM and she served as head of unit ‘Decentralised Procedure’ (1996-2002) and as deputy head of EU Division (2000-2002). She was member of and chaired the Mutual Recognition Facilitation Group and served as expert to the Committee for Human Medicinal Products (EMA).

From 2002–2006 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.

From September 2006 till October 2011, she was head of the division 3 Marketing Authorisation procedure at the BfArM compromising several indication areas including cardiovascular and pulmonary disease, antibiotics and dermatology.

She was head of Executive Department EU and International Affairs of the Federal Institute for Drugs and Medical Devices (BfArM) from October 2011 till end of 2015. She was member of the Paediatric Committee at the European Medicines Agency from 2007 till 2016.


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