Biologics Development: A Regulatory Overview

RGA 6200 4 Quarter Hours
Course Level CPS - Graduate
Description Offers students an opportunity to conduct a comprehensive and up-to-date analysis of the post-reform FDA Center for Biologics Evaluation and Research (CBER) and the complete U.S. biological product approval process, from preclinical testing to postmarketing regulatory requirements. Includes both CBER official and industry expert perspectives on quality assurance issues and related regulatory topics in successfully bringing biologics to market, as well as current good manufacturing practice regulations to assure quality of marketed products.


Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.


Course Sections

Section 06
CRN 20130
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Leona Saunders
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

Talk to an Enrollment Coach

We can walk you through your program options and the application process.


Call Toll Free:
Contact Us