PHRD-611: Introduction to Regulatory Affairs

Department
Credits 3.00
Academic Level
Doctorate (Professional Prac)
Instructional Method
Lecture
This course provides an overview of the U.S. Food and Drug Administration regulatory pathways for drug, biologics and medical devices. It also defines good laboratory, clinical and manufactur- ing practices. Additionally, it provides an overview of other products regulations such as cosmetics, veterinary, and food products. [ 3 credits ]