Frits is a Medical Advisor, with more than 40 years’ experience in regulatory affairs and clinical medicine. He’s a specialist in internal medicine and an expert in endocrinology, diabetes, coagulation disorders, clinical pharmacology and biosimilars.
Frits’ extensive experience provides companies with a clearer understanding of the complexities of the European approval system, DCP and national procedures.
Key Areas Of Expertise
- Extensive expertise in the inner workings of the EU regulatory systems
- CHMP Rapporteur for more than 30 products
- Dutch Member of the CPMP/CHMP
- Core-Member of the CHMP WP on Biosimilar Medicinal Products
- 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
- Experience in Medical Ethical Review in the Netherlands and former Chair of NVMETC (umbrella organization for Medical Ethics committees).
- Orphan medicinal products
- Clinical documentation requirements supporting European regulatory applications
- Experienced in Regulatory and scientific aspects incl. dossier assessment of a great variety of medicinal products
- Clinical development plan, scientific strategy, and design
- In-depth knowledge of issues related to Endocrine products, products in use for osteoporosis and diabetes & similar biological medicinal products
Before Joining The NDA Advisory Board
Frits was the Chair of the Dutch Medicines Evaluation Board for 16 years, a member of the Committee for Human Medicinal Products. He was also the Chairman of Advisory Committee Dutch National Plan on Orphan Diseases and Dutch Steering Committee on Orphan Drugs.
Advances in analytical characterization of biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(3):107, 109.
Dr Frits Lekkerkerker