Programs

Credential Awarded: Graduate Certificate
Total Semester Credits: 14
Method of Delivery: Hybrid
Program Description
The Graduate Certificate in Global Regulatory Affairs of Drugs and Medical Devices prepares students to develop the knowledge and skills needed to work effectively in the highly regulated pharmaceutical and medical device industries.
Through the program, students gain an understanding of regulatory environments in the United States, Europe, the MENA region, China, and Japan, while developing practical knowledge of regulatory processes related to drug and medical device development, manufacturing, marketing, and market authorization.
The curriculum addresses key areas of regulatory affairs, including operational and strategic regulatory affairs, clinical regulatory affairs, Chemistry, Manufacturing and Controls (CMC), regulatory submissions, global regulatory practices, and compliance.

Program Objectives
Upon completion of the program, students will be able to:
– Understand the regulatory framework governing drug development and medical devices.
– Evaluate global regulatory strategies supporting pharmaceutical and biological product development.
– Understand protocol development, study design, post-marketing surveillance, and regulatory submissions.
– Develop a regulatory strategy for a medical product.
– Analyze Good Manufacturing Practice (GMP) requirements for medical products.
– Understand and apply global strategies for drug, biologic, and medical device development and evaluation.
– Differentiate U.S. and international requirements for drug and biologic development and registration.
– Understand key Chemistry, Manufacturing and Controls (CMC) principles in drug development.
– Relate clinical research design principles to clinical trial management.
– Differentiate regulatory requirements and processes for drugs, biologics, biosimilars, medical devices, combination products, and cosmetics.