COURSE CURRICULUM

The Regulatory Affairs graduate certificate program at Humber is delivered entirely online with a flexible, student-centered approach across three semesters. In the first semester, students study foundational courses such as Regulatory Communications and Ethical Practice, Health Legislation, Regulations and Guidelines, Product Development – Chemistry, Manufacturing and Controls (CMC), Post Market Surveillance, and Drug Product Lifecycle, providing a solid grounding in regulatory frameworks and product development processes. The second semester builds on this foundation with courses on Regulatory Projects on Emerging Trends, Product Development – Premarket, Medical Devices, Provincial Formularies and Reimbursement Policy, Management of Regulatory Submissions, and Professional Preparation for Regulatory Affairs, ensuring students are up-to-date with current industry standards and practices. In the final semester, students choose between a hands-on Field Experience in Regulatory Affairs, offering valuable in-person practical learning, or a Capstone project delivered online that integrates their knowledge through a comprehensive research or applied project. This curriculum is designed to equip students with the regulatory expertise and communication skills necessary for successful careers in various industries, including pharmaceuticals, healthcare, biotechnology, food, and cosmetics. The program’s focus on ethical practice, emerging trends, and professional preparation ensures graduates are ready to navigate complex regulatory environments and contribute effectively to their organizations.