Therapeutic Product Development: A Regulatory Overview

RGA 6101 4 Quarter Hours
Course Level CPS - Graduate
Description Examines every step of the therapeutic development and regulation process within the Center for Biologic Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER), from preclinical testing through postmarketing adverse experience reporting and offers students an opportunity to conduct a comprehensive and up-to-date analysis of the complete U.S. pharmaceutical and biological products approval processes. Considers FDA standards for nonclinical testing-quality assurance issues and good laboratory practice, investigational new drug (IND) applications, therapeutic market applications and review process initiatives designed to speed therapeutic product review, as well as current good manufacturing practice regulations to assure quality of marketed products.

Prerequisites

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

 

Course Sections

Section 01
CRN 20905
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Samantha Zappia
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 02
CRN 20906
View Syllabus Download
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Kaia Agarwal
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 20961
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Samantha Zappia
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
Section 05
CRN 20963
View Syllabus Download
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Thomas Koperniak
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 06
CRN 20964
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Stephen Amato
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
Next Term Starts
  • Winter Graduate
    Jan 8, 2018 (6- and 12-week classes)
    Feb 19, 2018 (6-week classes)

Academic Calendar

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