Post-Approval Compliance Requirements for Pharmaceutical Products

Instructor

Dr. Darin S. Oppenheimer is Executive Director of the Drug Device Center of Excellence, focusing on Medical Devices and Combination Products at Merck, based in Upper Gwynedd, PA. Darin joined Merck with 16 years of experience in many facets of the Product Development Lifecycle, including regulatory submissions and due diligence. He has actively participated with industry trade organizations and served on standards committees. His time as a research and development scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Darin’s educational background includes an undergraduate degree in Molecular Biology from the University of Tampa, two master’s degrees from Johns Hopkins University in Biotechnology and Regulatory Science, and a Certificate in Biotechnology Enterprise also from JHU. Darin completed his Doctorate in Regulatory Science from the University of Southern California in 2016. Darin is also a 2017 Regulatory Affairs Professional Society Fellow. Darin has contributed to more than two dozen journal articles in the areas of medical devices, drug discovery, and regulatory affairs. He’s lectured at more than three dozen symposia, and participated in panel discussions and poster presentations at industry conferences. Darin serves on the Editorial Board of the Regulatory Affairs Professional Society, as well as the Editorial Board of the Institute of Validation Technology.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

Optional Textbook(s):

Fundamentals of US Regulatory Affairs
Book - ISBN: 9780997769777
Regulatory Affairs Professiona, 10 ed

Meeting Schedule