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LAW 785S Legal Regulation of Pharmaceutical and Medical Device Research and Development 3.0 Credits

This course explores the regulatory entities and schemes governing the research and development, management, financing, and reporting requirements of clinical trials in the pharmaceutical and life sciences sectors. Topics include the role of the Institutional Review Board, compliance with Good Clinical Practice standards, informed consent, pharmacovigilance and the protection of human research subjects, payments and financial transparency, conflicts of interest, ethical considerations in designing and executing clinical trials, and reporting requirements.

College/Department: Thomas R. Kline School of Law
Repeat Status: Not repeatable for credit