This course examines the operational, strategic and commercial aspects of the regulatory approval process for new medical devices, biologics, and combination products in the United States. The topics are designed to provide a chronological overview of the requirements needed to seek marketing approval. The goal of this course is to introduce and familiarize students with the terminology, timelines and actual steps followed by Regulatory Affairs professionals employed in the medical device, pharmaceutical, or biotechnology industry. Case studies from industry will be examined to supplement certain topics and to illustrate interpretation of regulations.
Prerequisite of ALS 362
After completing this course, students should have: