Mr. Erik Doevendans
Trainer
Erik Doevendans MSc is a highly experienced regulatory and CMC expert with more than 25 years in the biopharmaceutical industry, with a strong focus on advanced therapy medicinal products (ATMPs). He obtained his MSc in Pharmacy from Utrecht University in 1997, complemented by further studies in Molecular Biology and Biostatistical Methods. Over the course of his career, Erik has held senior roles in regulatory agencies, consultancy, and industry. As Senior Assessor at the National Institute for Public Health and the Environment (RIVM), he evaluated biological and biotechnological medicinal products, including some of the first biosimilars in Europe, and contributed as an expert to the EMA’s Biologics Working Party. He later became Senior Director Regulatory Affairs & Manufacturing Operations at Pharming N.V., where he led regulatory strategies in both the US and Europe and oversaw CMC and manufacturing operations for novel biologics. Since 2009, Erik has worked as an independent consultant and senior advisor, guiding numerous biotech companies in the development, regulatory submissions, and CMC strategies for ATMPs, gene therapies, and other complex biologics. His work spans preparation of EMA and FDA dossiers, scientific advice procedures, and hands-on support in solving regulatory and manufacturing challenges. Erik is also a published author on ATMP development and quality considerations, including his recent contribution to Pharmaceutical Biotechnology (Springer, 2024). His deep expertise and long-standing involvement with ATMP regulatory science make him an ideal trainer to help participants navigate the complex scientific, regulatory, and operational requirements of this innovative field.
Reasons to attend Bridging Preclinical to Clinical Development is a must-attend course for anyone w...