Frank Holtkamp

Background

About Frank Holtkamp

In more than 15 years of experience, I have built solid (clinical and regulatory) expertise in (Centralised) Medicinal Product Applications resulting in a leading position in reviewing of more than 20 Rapporteurships of Centralised (CHMP) Medicinal Product Applications, and CHMP decision making (Committee for Medicinal Products for Human Use). My job has evolved in a functional leadership position of a team of clinical (and regulatory) professionals characterized by working every day on improving and maintaining an inspiring and effective working environment including transparent and clear communication, shared decision making and clear and realistic working goals. Other experience include several (organization) policy and project activities. Additional international engagement includes member ships of several network groups. This includes core-member of the CHMP Rheumatology and Immunology Working Party (RIWP) with key involvement in the guidance of clinical drug development programs (e.g. Scientific Advice through SAWP, development of EMA clinical guidelines on drug development). Also, member of the ICH (International Council for Harmonization) network for global guidance on the clinical evaluation of proarrhythmic potential. My expertise is mainly focused on in-depth knowledge in cardiology, cardiometabolic, cardiorenal, kidney associated pathophysiology’s (including benign hematology), HTA medicinal device consultations, pediatric drug development, fixed dose combination products, amongst others.