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Michael VanDerWerf

Director, Regulatory Affairs @ Organogenesis, Inc

Michael VanDerWerf Contact Details

San Diego, California, United States
Director, Regulatory Affairs @ Organogenesis, Inc
Director - Regulatory Affairs CMC @ Shire Regenerative Medicine
Assoc. Director, US Regulatory Affairs - Vaccines @ GlaxoSmithKline Biologicals
BA Biology, Evolutionary Biology/Genetics and Philosophy of Science @ University of Minnesota

Specialties: Regulatory Affairs Biologics and Combination Products, CMC, cGMPs, biologics manufacturing/testing, tissue engineering Chair PDA - Biologics Advisory Board (BioAB) Former Member PDA Reg Affairs and Quality Committee (RAQC)

Director, Regulatory Affairs @ Challenging regulatory and reimbursement environment for tissue regeneration products. Global regulatory responsibilities for PMA, BLA and 510(k) bioengineered tissue products manufactured in Massachusetts and California. 

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