Nov 23, 2020  
2013-2014 University Catalog 
    
2013-2014 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