Biopharmaceutical Domestic Regulatory Affairs, Graduate Certificate

The biotechnology and pharmaceutical industries continue to experience rapid growth in the U.S. market. As companies in these industries seek approval to market their products in the United States, demand for qualified regulatory affairs professionals continues to increase. Product development scientists, marketers, quality personnel, as well as legal experts that guide companies through the Food and Drug Administration (FDA) approval process, will benefit from regulatory affairs training.

The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of U.S. biologic and pharmaceutical product regulation and their unique development, marketing, manufacturing, and postmarket approval-related issues. The program also seeks to prepare students to ensure regulatory compliance, proper validation, and utilization of proper quantitative measurement techniques. Courses from this certificate may be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.

Complete all courses and requirements listed below unless otherwise indicated.

Required Courses

RGA 6200Biologics Development: A Regulatory Overview4
RGA 6201New Drug Development: A Regulatory Overview4
RGA 6202Medical Device Development: A Regulatory Overview4
Complete one of the following:4-5
Food, Drug, and Medical Device Law: Topics and Cases
Strategic Planning and Project Management for Regulatory Affairs
Combination Products and Convergence
Introduction to Safety Sciences
The Food and Drug Administration: Creation, Behavior, Regulatory Culture
The Medical, Social, and Financial Dimensions of Orphan Drugs
Biomedical Product Development: From Biotech to Boardroom to Market
Regulatory Writing: Medical Device Submissions
Regulatory Writing: New Drug Applications

Program Credit/GPA Requirements

16 total quarter hours required
Minimum 3.000 GPA required