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.