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 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6101Therapeutic Product Development: A Regulatory Overview4
Complete the appropriate number of electives to meet the minimum quarter-hour requirement: 10-12
Human Experimentation: Methodological Issues Fundamentals
Regulatory Compliance Culture
Pharmaceutical and Medical Device Law: Topics and Cases
Global Impact of Electronic Common Technical Document (eCTD) Submissions
Strategic Planning and Project Management for Regulatory Affairs
Introduction to Safety Sciences
Project Management in Early Drug Discovery and Development
The Medical, Social, and Financial Dimensions of Orphan Drugs
Biomedical Product Development: From Biotech to Boardroom to Market
Advanced Regulatory Writing: New Drug Applications
Fundamentals of CMC Regulations and Methods

Program Credit/GPA Requirements

16 total quarter hours required
Minimum 3.000 GPA required