Meike Vanhooren

Dr. Vanhooren has more than 25 years of experience in the pharmaceutical industry covering regulatory, manufacturing and quality areas. She is based in Germany and has global responsibility for Chemistry Manufacturing Control (CMC). Her portfolio touches the complete product life cycle, from IND /IMPDs for First-in-Human clinical studies, NDA / MAA applications through commercial product maintenance. With her team she is accountable for: effectively engaging regulatory authorities and ensuring legal obligations to maintain conformance and compliance are met; and developing regulatory strategies globally and providing regulatory clarity for scientists in research & development and manufacturing divisions. Dr. Vanhooren has extensive experience in drug development of accelerated programs as well as programs with novel technologies such as continuous manufacturing processes. She has been responsible for several oncology product applications with simultaneous MAA / NDA submissions. She also has extensive experience in Lifecycle Management. She has been responsible for executing CMC strategies for manufacturing site changes and successfully completed more than 900 transfers impacting more than 22.000 licenses globally. Dr. Vanhooren is engaged at the European Federation of Pharmaceutical Industry (Efpia) and has had opportunity to interact with senior regulators to discuss industry positions on Q12 Lifecycle Management and Q13 Continuous Manufacturing. Dr. Vanhooren earned her Ph.D. in organic synthesis of carbohydrate structures at the University of Hamburg, Germany.