Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation

RGA 6000 2 Quarter Hours
Course Level CPS - Graduate
Description Offers students an overview of pharmaceutical and biologic product clinical and regulatory development in addition to a description of the Food and Drug Administration’s (FDA’s) involvement in the process. Through course work and participation, the course offers students an opportunity to develop an understanding of fundamental pharmaceutical and biologic regulatory affairs from a U.S.-centric perspective. Incorporates a review of the historical development of U.S. pharmaceutical legislation and statute development, FDA and industry functions, as well as a review of significant case law that has shaped the present state of regulation.

Prerequisites

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

 

Course Sections

Section 02
CRN 70912
View Syllabus Download
Session Fall 2017 CPS Quarter - Second Half
Class Meeting Dates 10/30/2017 to 12/16/2017
Instructor Jennifer Kelley
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 70915
View Syllabus Download
Session Fall 2017 CPS Quarter - Second Half
Class Meeting Dates 10/30/2017 to 12/16/2017
Instructor Thomas Koperniak
Schedule Wednesday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 06
CRN 70916
Session Fall 2017 CPS Quarter - Second Half
Class Meeting Dates 10/30/2017 to 12/16/2017
Instructor Supicha Kridaratikorn
Schedule Thursday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 01
CRN 20895
Session Winter 2018 CPS Quarter - First Half
Class Meeting Dates 01/08/2018 to 02/17/2018
Instructor Supicha Kridaratikorn
Schedule Tuesday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 02
CRN 20896
Session Winter 2018 CPS Quarter - First Half
Class Meeting Dates 01/08/2018 to 02/17/2018
Instructor Supicha Kridaratikorn
Schedule Thursday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 03
CRN 20897
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 02/20/2018 to 03/31/2018
Instructor Supicha Kridaratikorn
Schedule Tuesday, 5:50 pm - 8:30 pm
Campus Boston Main Campus
Course Format Traditional
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 04
CRN 20899
Session Winter 2018 CPS Quarter - First Half
Class Meeting Dates 01/08/2018 to 02/17/2018
Instructor Brian Caselli
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 20898
Session Winter 2018 CPS Quarter - Second Half
Class Meeting Dates 02/20/2018 to 03/31/2018
Instructor Brian Caselli
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
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