Regulatory Affairs

Catalog description

This course provides students with an overview of regulatory affairs within thepharmaceutical sciences and clinical research industries, with emphasis onrequirements for initiating trials, developing pharmaceutical products, andgaining approval for worldwide marketing applications. Topics include datasubmission requirements, quality procedure regulations, Good ManufacturingPractices, Good Clinical Practices, and marketing considerations. Practicalexercises simulate tasks representative of entry level regulatory affairs positionswithin pharmaceutical companies, contract research organizations, and regulatoryagencies When Offered: Fall Term, All Years