RGA 7130 — Research Methodologies in Regulatory Affairs
3 semester hoursGraduateLecture
Explores the significance of regulatory science as an emerging yet critical data-driven discipline exemplified by recent FDA initiatives to codify and document its development. Offers students an opportunity to develop expertise in methodologies to evaluate the effectiveness of regulatory strategies. Analyzes methodologies from both retrospective and prospective vantage points. Assesses the impact of user fees, new guidance documents, and evolving regulatory paradigms for the commercialization of pharmaceutical, biologic, and medical device products. Supports development of doctoral dissertation ideas through the application of research methodologies.