Regulatory Science in Drug Dev

Catalog description

PHSC 680B: Regulatory Science in Drug Development This course will provide an in-depth overview of regulatory science as practice during drug development. The primary focus will be on the US regulatory system (FDA), with additional training in the European system (EMA). The nature and mechanics of the interactions between the drug developer (Sponsor) and regulatory body (FDA) will be explained, and then practiced through a series of role-playing tutorials using the vamorolone drug approval pathway as an exemplar. The original documents from the vamorolone program, from pre-IND, Phase I to Phase II transition, Phase II to Phase III transition, and pre-NDA meetings will be studied. Current controversies in regulatory science will be studied in parallel, as a means of emphasizing critical aspects of the regulatory rationale utilized through the clinical drug development pipeline. [