A required course in the Certificate Program Regulatory Affairs and Compliance.
Product approval is a crucial milestone in a product’s lifecycle, after which, the marketing phase begins and post-approval compliance requirements commence. This course explores the FDA regulatory requirements for drugs and biologics following product approval. Some of the areas covered include promotional labelling and advertising, post-marketing surveillance (e.g. adverse events, recalls), post-marketing commitments, post-approval manufacturing changes, post-approval submissions to the NDA/BLA, supply chain management, and quality systems, including compliance with 21 CFR 11 governing electronic records. Students who complete this course will be equipped with relevant knowledge and skills needed to meet post-approval regulatory requirements.
Recommended Prerequisite: PHRMSCI_X480 -Introduction to Regulatory Compliance for Drugs, Biologics, and Medical Devices.
NOTE: This course utilizes Zoom for weekly live online synchronous meetings. The sessions will be recorded and posted for students who are not able to attend, watching the recording is mandatory. The Zoom meeting link and password to join will be provided in your course. A device with audio and visual will be needed to participate. The following student guide provides additional resources/information on how to use and access your courses Zoom sessions.
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||06/21/2021||Monday||---||---||Online (Access Begins)||---
|OL-LEC||06/21/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||06/28/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||07/05/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||07/12/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||07/19/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||07/26/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||08/02/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||08/09/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||08/16/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|OL-LEC||08/23/2021||Monday||6:00 PM||7:00 PM||Zoom||---
|END||08/29/2021||Sunday||---||---||Online (Access Ends)||---