Regulatory Affairs Humber Polytechnic

Program Description

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 that 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 field experience occurs in Semester 3 and is in-person. This program is not available to international applicants.

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