REGS 641 REGULATED PRODUCTS IN THE MARKETPLACE
FDA approval for the marketing of the drug or other regulated product (e.g., biologics, vaccines, medical devices, laboratory tests) is a major milestone in a product's lifecycle. But it doesn't stop there. Once on the market, how a drug is used and by whom, entry of competing products into the marketplace, and changes in medical care can change the benefit-risk balance. This course covers the breadth of clinical research and surveillance activities take place in the post-approval phase of a regulated medical product's lifecycle. This includes pharmacovigilance and risk management activities, pharmacoepidemiology, pharmacoeconomics, comparative effectiveness, and drug utilization research. The course is designed to prepare students to communicate across the pre-/post-marketing divide, evaluate the need for post-marketing studies, and to be able to critically interpret and apply the results of such studies.