Regulatory Strategy and FDA Communications

Catalog description

The Regulatory Strategy and FDA Communications course is a class structured to give students the knowledge and resources to generate strategic approaches for regulated medical products in the US. These include drug products, medical devices, biologic products, and combination products. The course will review common sources for regulatory intelligence gathering and their applicability to each type of medical product. Additionally, students will be tasked to craft a fully formed regulatory strategy for a medical product of their choosing to reinforce their learning and understanding of course concepts. Proposed strategies include pre-development testing of possible market products as well as post-market corporate development plans. Additionally, FDA regulatory requirements for product development and marketing and FDA communication mechanisms will be covered as well as common types of meetings conducted. Students will learn to integrate key timepoints, communications, and/or meetings for the development of their regulatory strategies. Offered as MGRD 530 and PHRM 530 . Prereq: CRSP 529 or MGRD 529 or PHRM 529 or RGME 529 .