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

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
Next Term Starts
  • Summer Graduate
    Jul 10, 2017 (4-, 6-, and 8-week classes)
    Aug 7, 2017 (4-week classes)
  • Fall Undergraduate
    Sep 4, 2017 (7.5- and 15-week classes)
    Oct 25, 2017 (7.5-week classes)
  • Fall Graduate
    Sep 18, 2017 (6- and 12-week classes)
    Oct 30, 2017 (6-week classes)

Academic Calendar

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