Medical Products Safety

Course Code: REGA 5023

Academic Year: 2019-2020

This course outlines the post-marketing support functions of a regulatory affairs department. Regulatory aspects of pharmacovigilance systems, including receipt and processing of case reports, literature reviews, post-marketing surveillance systems, signal detection, and safety reporting; labeling changes; principles of marketing (advertising, sales promotion and distribution) to the medical community and to consumers; risk management systems; complaint handling; and audits and inspections are covered.