4.0

credits

Average Course Rating

The ability to successfully navigate the intersections of law, regulation, guidance, and policy has never been more critical to the success of entities engaged in medical product development and commercial marketing. The entities that make up this industry are very sophisticated in their abilities to innovate at a blazing speed. In contrast, regulators must use a regulatory model that evolves and adapts much slower than their industry counterparts. As a result, regulators are relying more heavily on policy to drive their strategy, actions, and outcomes. Therefore, a clear understanding of regulatory policy is an essential consideration for individuals engaged in the medical product development industry. This course provides an introduction to several key areas of government regulatory policy (both old and new) and regulatory science. The topics covered in this course will serve as a road map for students who want to successfully navigate within this complex and changing regulatory model.