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.

Trine Moulvad has an MSc from University of Copenhagen, Denmark. She is an all-round experienced drug developer and leader with more than 25 years of experience within the pharmaceutical industry. She previously worked at Eli Lilly, Ferring and Novo Nordisk in global Regulatory leadership capacities, and have most recently gained experience from the 'small business' world of biotech at Zealand Pharma heading up Regulatory, Pharmacovigilance and Medical Writing accountable for successful Agency negotiations and taking projects from early development through to regulatory submission and approval in both US and EU. Engaged in trade associations as well as teaching and course leadership for DIA and other training organizations.