Regulatory Affairs

Humber College is a publicly-funded college located in Toronto, Ontario, Canada. It was founded in 1967 and offers a range of certificate, diploma, and degree programs in a variety of fields, including business, technology, health sciences, media, and more. The college has a diverse student population, with over 33,000 full-time and part-time students enrolled each year, including international students from over 138 countries. Humber College has a strong focus on experiential learning, offering students opportunities for hands-on learning through co-op programs, internships, and work placements. The college has partnerships with over 500 employers, providing students with access to a range of job opportunities and real-world experience. Humber College is known for its state-of-the-art facilities, including its Centre for Trades and Technology, which offers training in a variety of skilled trades, and its Barrett Centre for Technology Innovation, which provides students with access to cutting-edge technology and equipment. The college is also committed to sustainability, with a number of initiatives in place to reduce its environmental impact and promote sustainable practices.

Humber’s Regulatory Affairs graduate certificate program equips graduates with the transferable skills needed to build successful careers in a variety of sectors requiring regulatory affairs expertise and training. This online program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, health products, medical devices, biotechnology industries, food industries and other sectors that require a regulatory component. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related and consumable products. The importance of internationally harmonized regulations and future trends in the industry is examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices (GMP), good laboratory practices (GLP), good clinical practices (GCP), good documentation practices (GDP), the International Organization for Standardization (ISO), the Canadian Food and Drugs Act (CFDA), the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines. Teamwork and communication skills are reinforced throughout the program, and you will acquire information technology skills that assist communication and data management specific to regulatory affairs. You will become familiar with the steps necessary for product submission; assembling documents and statistical evidence; the complexity of product registration, negotiation and follow-up; and linking the federal government and provincial formularies. Program Delivery: Courses are scheduled over two 14-week semesters and offer a blend of self-directed online modules and synchronous remote classes. A work placement occurs in Semester 3 and is in-person. This program is not available to international applicants.