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: 2.50 unit(s)
Related Certificate Programs: Regulatory Affairs Essentials
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6/24/2019 - 8/26/2019