May 11, 2021  
2020-2021 University Catalog 
2020-2021 University Catalog [ARCHIVED CATALOG]

BW 704 - Regulatory Documentation Processes

This course is an introduction to the drug development process from the regulatory medical writer’s point of view. Specific topics include the ethics of using human subjects in clinical research, overviews of U.S. and international regulatory agencies, product life cycles, the conduct of clinical trials and reporting clinical trial results, and activities and documentation involved with submissions for marketing approval of treatments. This is a core course for both the MS in biomedical writing and regulatory writing certificate programs.

Prerequisites & Notes
(Prerequisite: permission of program director)

Credits: 3