International Biopharmaceutical Regulatory Affairs, Graduate Certificate

To work in today’s global biopharmaceutical industry, there is a strong need to understand international regulations that impact the development, marketing, and manufacturing of pharmaceutical and biotechnology products.

The Graduate Certificate in Biopharmaceutical International Regulatory Affairs curriculum focuses on factors that facilitate the safety, performance, and efficacy of biomedical goods. Program training covers the assessment of international regulations and interpretation of their likely impact on a company’s global commercialization strategies. Through participation in the program, students will have an opportunity to gain an understanding of international regulatory requirements necessary to implement such strategies.

Course work covers biotechnology and pharmaceutical product approval processes, regulatory analysis, and liability laws as they exist across different regulatory systems. The graduate certificate will provide core regulatory knowledge to students entering into the field from bench research, clinical studies, quality control/assurance, pharmacy, bioengineering, business, and legal analysis. The curriculum covers regulatory environments in Europe, Latin America, Australia, Japan, and other emerging economies. 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 6221European Union Compliance Process and Regulatory Affairs4
RGA 6241Working in Multicultural Environments: Challenges and Opportunities2
Complete two of the following:8
Legal Issues in International Food, Drug, and Medical Device Regulation
Global Impact of Electronic Common Technical Document (eCTD) Submissions
Strategic Planning and Project Management for Regulatory Affairs
Introduction to Safety Sciences
Introduction to Canadian, Asian, and Latin American Regulatory Affairs
Regulation of Biomedical Product Commercialization by Health Canada
Biomedical Product Regulatory Affairs in Emerging Markets: Russia and Kazakhstan
RGA 6240
Therapeutic Product Development in Canada
Regulation of Generic Pharmaceutical and Biosimilar Products
Chinese Food and Drug Administration Regulation of Biomedical Product Commercialization
Global Convergence of Regulatory Science and Reimbursement/Market Access

Program Credit/GPA Requirements

17 total quarter hours required
Minimum 3.000 GPA required