Regulatory Requirements for Drugs & Biologics

Discover the FDA regulatory requirements as they pertain to biotech and pharmaceutical companies. In this course, you will review topics such as: FDA organization and operations; U.S. Pharmacopoeial convention; INDs; the product development process; product characterization and pre-clinical evaluation; pharmacology/toxicology for new drugs and GLPs; clinical investigations, bioresearch monitoring and GCPs; and CMC requirements and GMPs. Also covered are the roles that regulatory affairs professionals play in the process.

Note: Some background in science is presumed but is not required.

Course Number: BIOL-40102   Credit: 2.5 units

This course is part of the following Certificate Program(s):

• Regulatory Affairs Essentials

• Regulatory Affairs for the Biomedical Industry