Regulatory Requirements for Pharmaceutical Products
A required course in the Clinical Trials: Medical Device & Drug Development and Regulatory Affairs & Compliance for Pharmaceuticals Certificate Programs.
This course presents a detailed overview of the regulatory requirements for the discovery, development, and commercialization of pharmaceutical products (drugs and biologics). Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization, product characterization and pre-clinical evaluation, pharmaceutical industry requirements, clinical trial requirements, good manufacturing practices (GMPs), good laboratory practices (GLPs) and inspections, labeling medical products and writing Food and Drug Administration (FDA) submissions.
SPRING 2025
Class Schedule
| Event | Date | Day | Start Time | End Time | Location | Room |
|---|---|---|---|---|---|---|
| Event Start | Date 3/31/2025 | Day MON | Start Time | End Time | Location Online (Access Begins) | Room --- |
| Event No Meeting | Date 4/1/2025 | Day TUE | Start Time | End Time | Location --- | Room --- |
| Event Synchronous Meeting | Date 4/2/2025 | Day WED | Start Time 03:00 PM | End Time 04:00 PM | Location Zoom | Room |
| Event Synchronous Meeting | Date 4/15/2025 | Day TUE | Start Time 01:00 PM | End Time 02:00 PM | Location Zoom | Room |
| Event Synchronous Meeting | Date 4/29/2025 | Day TUE | Start Time 01:00 PM | End Time 02:00 PM | Location Zoom | Room |
| Event Synchronous Meeting | Date 5/13/2025 | Day TUE | Start Time 01:00 PM | End Time 02:00 PM | Location Zoom | Room |
| Event Synchronous Meeting | Date 5/27/2025 | Day TUE | Start Time 01:00 PM | End Time 02:00 PM | Location Zoom | Room |
| Event End | Date 6/8/2025 | Day SUN | Start Time | End Time | Location Online (Access Ends) | Room --- |
Textbook Information for EECS X445.26.
Optional Textbook(s):
Meet Your Instructor(s)
Special Notes
This course will host live sessions via Zoom. A device with audio and visual will be needed to participate. Synchronous sessions are highly encouraged for an interactive learning experience but are optional. Sessions are recorded and available for viewing, allowing learners to engage with the content at their convenience.
SUMMER 2025
Class Schedule
| Event | Date | Day | Start Time | End Time | Location | Room |
|---|---|---|---|---|---|---|
| Event Start | Date 6/23/2025 | Day MON | Start Time | End Time | Location Online (Access Begins) | Room --- |
| Event End | Date 8/31/2025 | Day SUN | Start Time | End Time | Location Online (Access Ends) | Room --- |
Textbook Information for EECS X445.26.
Optional Textbook(s):
Meet Your Instructor(s)
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