Frits Lekkerkerker, MD

Member of International Editorial Advisory Board, GaBI Journal

Certified in Internal Medicine
NDA Advisory Board Member
Advisor, Medicines Evaluation Board, The Netherlands

Dr Frits Lekkerkerker is a medical doctor, specialised in internal medicine. His medical specialties cover endocrinology including osteoporosis, diabetes, clinical pharmacology, ultrasound, CHMP Rapporteur/Co-Rapporteur for diabetic products, blood products, vaccines and other products in the centralised procedure and in many referrals of national authorised products to the CHMP.

Currently, Dr Lekkerkerker is NDA Advisory Board Member, Chairman of the Medicines Evaluation Board of MST Enschede, The Netherlands (teaching hospital), Chairman of the Dutch steering committee on orphan medicinal products, Chairman of NVMETC (Dutch Society of Medicinal Ethics Review Committee), Dutch umbrella organisation of MECs; and Chairman of the committee on medicines NFK (Dutch cancer patient organisation).

Previously, Dr Lekkerkerker was Chairman of the Dutch Medicines Evaluation Board (1991–2007). Also between the periods 1991–1996 and 2001–2007 he served as a member of CHMP (Committee for Medicinal Products for Human Use), EMA London (UK); a core-member of the CHMP WP (working parties) on Biosimilar Medicinal Products; co-chairman and later member of the CPMP (Committee for Proprietary Medicinal Products)/EMA working group with patient organisations; also a member of the Dutch Medicines Evaluation Board (1974–2001); Specialist/Coordinator, Department of Internal Medicine/Endocrinology MST Hospital (1973–2001) and Head of Haematology Laboratory/Hospital De Stadsmaten, Enschede, The Netherlands (1973–1976). He was Consultant in Endocrinology at the University Hospital Groningen, The Netherlands (1969–1973).

He has expertise of more than 30 years in regulatory affairs, in decision making processes, and in clinical medicine. Dr Lekkerkerker has detailed knowledge of the European approval system including EMA, decentralised procedure and national procedures, CHMP Rapporteurship for more than 30 products, experience of regulatory and scientific aspects, and in-depth knowledge of issues related to endocrine products, products in use for osteoporosis and diabetes, in biosimilars/similar biological medicinal products.

Dr Lekkerkerker has a portfolio of publications and conference presentations on all aspects of regulatory affairs, especially those related to osteoporosis, similar biological medicinal products and bioequivalence.