May 13, 2021  
2020-2021 University Catalog 
2020-2021 University Catalog [ARCHIVED CATALOG]

BW 722 - Regulatory Writing: Biologics

This course examines the process of writing regulatory documentation for biologics. Topics covered include FDA regulation of biologics, the biological product development process, and clinical study documents. Students will practice communicating complex scientific information in various documents for biologics. This course builds upon the foundation from BW 704 to focus in depth on the particular issues unique to biologics.

Prerequisites & Notes
(Prerequisite: BW 704 or permission of program director)

Credits: 3