CT: Regulation of Drugs, Biologics, Devices, and Diagnostics

This course reviews the breadth of U.S. and international regulations associated with the development of drugs, biologics, medical devices, and diagnostics.

Topics include a review of regulatory agencies and the role/responsibilities of each; pathways for regulatory applications; important differences between development processes in the U.S. and those of other countries; and the impact of regulatory approval processes on corporate strategy.