Post-Approval Compliance Requirements for Pharmaceutical Products
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 labeling 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.
WINTER 2024
Class Schedule
Event | Date | Day | Start Time | End Time | Location | Room |
---|---|---|---|---|---|---|
Event Start | Date 1/8/2024 | Day MON | Start Time | End Time | Location Online (Access Begins) | Room --- |
Event OL-LEC | Date 1/8/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 1/15/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 1/22/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 1/29/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 2/5/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 2/12/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 2/19/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event End | Date 2/25/2024 | Day SUN | Start Time | End Time | Location Online (Access Ends) | Room --- |
Textbook Information
Optional Textbook(s):
Special Notes:
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.
SUMMER 2024
Class Schedule
Event | Date | Day | Start Time | End Time | Location | Room |
---|---|---|---|---|---|---|
Event Start | Date 6/24/2024 | Day MON | Start Time | End Time | Location Online (Access Begins) | Room --- |
Event OL-LEC | Date 6/24/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 7/1/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 7/8/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 7/15/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 7/22/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 7/29/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event OL-LEC | Date 8/5/2024 | Day MON | Start Time 06:00 PM | End Time 07:00 PM | Location Zoom | Room |
Event End | Date 8/11/2024 | Day SUN | Start Time | End Time | Location Online (Access Ends) | Room --- |
Textbook Information
Optional Textbook(s):
Error
Course is already in progress.
You will be assessed a $25 late fee if you are enrolling one day after the course start date. You should work with the instructor to catch up on coursework.
Click OK if you still wish to enroll. Otherwise, click Cancel.