Regulatory Requirements for Drugs & Biologics

BIOL-40102  Credit: 2 units

Aimed at individuals seeking a big picture of the regulatory process, this course will focus on FDA regulatory requirements as they pertain to biotech and pharmaceutical companies. Topics include FDA organization and operations; U.S. pharmacopoeial convention; INDs; the product development process through commercialization; product characterization and pre-clinical evaluation; pharmacology/toxicology for new drugs and GLPs; clinical investigations, bioresearch monitoring and GCPs; and CMC section requirements and GMPs. Also covered are the U.S. market authorization requirements and applications and the roles that regulatory affairs professionals play in the process.

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

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

• Regulatory Affairs Essentials

• Regulatory Affairs for the Biomedical Industry

There are no sections of this course planned for the current quarter. Please contact the Life Sciences department at or unexbio@ucsd.edu for information about when this course will be offered again.