A required course in the Certificate Program in Regulatory Affairs and Compliance.
Learn how to organize your medical product design teams to meet the stringent FDA requirements and Regulatory Affairs. This course has two phases, concept review and evaluation review that provides a baseline knowledge on the role of regulatory affairs professional. Participants learn how to guide medical product designers through the design and development stages based on product classification to demonstrate safety and efficacy or performance for human use; and regulatory approval. Participants will be guided on how to conduct pre-submission meetings with the FDA, how to request meetings with the FDA, prepare and send pre-IDE packets, and how to record and document meetings with the FDA.
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.
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
No textbooks are required for this course.
|Event||Date||Day||Start Time||End Time||Location||Room
|START||09/25/2023||Monday||---||---||Online (Access Begins)||---
|END||12/03/2023||Sunday||---||---||Online (Access Ends)||---