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 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.
|RGA 6000||Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation||2|
|RGA 6101||Therapeutic Product Development: A Regulatory Overview||4|
|RGA 6207||Global Impact of Electronic Common Technical Document (eCTD) Submissions||4|
|RGA 6380||Advanced Regulatory Writing: New Drug Applications||4|
|Complete one of the following:||4|
|Biomedical Product Development: From Biotech to Boardroom to Market|
|Emerging Product Categories in the Regulation of Drugs and Biologics|
Program Credit/GPA Requirements
18 total quarter hours required
Minimum 3.000 GPA required