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.

Lene Melchiorsen is Project Vice President in Global Development at Novo Nordisk. She has been with the company for 15 years in various positions within Regulatory Affairs, Competitive Intelligence and Clinical Supplies. She holds a MSc in Pharmacy from the University of Copenhagen with her Master Thesis from the University of the Pacific, California, USA. Besides this, she holds a Diploma in Regulatory Affairs, BIRA (now TOPRA) and University of Wales, UK with a thesis on the impact of the clinical trial directive on clinical development in EU. Most recently, she completed the Strategy Execution Programme and Strategic R&D Management Programme at INSEAD, France.