Diverse regulatory experience from early phase development projects, through late phase and late phase life-cycle management, with focus on regulatory strategies and developing people and teams

Birka Lehmann, MD joined the Eu-Commission from 2002 -2006 responsible for centralised and decentralised marketing authorisation of medicinal products for all therapeutic areas Implementation of the European Legislation for Good Clinical Practice in charge of relevant committees at the EMA. From 2006 – 2011 head the Licensing Division 3 BfArM Scientific processing and administration of all national and European licensing procedures for medicinal products including scientific and regulatory advice. From 2006-2016 she was the German member of the Paediatric Committee (PDCO) at the EMA. Dr. Lehmann studied Medicines at the Free University Berlin and trained at the Kinderklinik Norderney.