Graduate Certificate in Regulatory Affairs

Humber College - North Campus

Canada,Ontario

 1 Shortlist

12 Months

Duration

CAD$ 26,202/year

Tuition Fee

CAD$ 75

Application Fee

Apply Date

Canada, Ontario

Type: College

Location Type: Urban

Founded: 1967

Total Students: 52,800 +

Int. Students: 3,800 +

Campus Detail

Main Campus Address

205 Humber College Blvd, Etobicoke, ON M9W 5L7, Canada

Graduate Certificate in Regulatory Affairs

Program Overview

Humber’s Regulatory Affairs graduate certificate program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. 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 products. 

The importance of internationally harmonized regulations and future trends in the industry will be examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices, good laboratory practices, good clinical practices, good documentation practices, the International Organization for Standardization (ISO), the Canadian Food and Drugs Act, the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines. Teamwork and communication skills are emphasized 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; how to assemble documents and statistical evidence; the complexity of product registration, negotiation and follow-up; and how these are linked to the federal government and provincial formularies.

Following two academic course-based semesters, students complete a three-month placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Most placements are in the following sectors: pharmaceutical, biotechnology, medical device organizations, government agencies or food industries.

The pharmaceutical industry is facing constant development. As society is aging more focus is being given to the development of new drugs and the improvement of health care. The comprehensive training we provide, combined with previous degrees and work experience, make our students highly marketable. Our graduates work in a spectrum of fields such as pharmaceutics, biotechnology, medical devices, natural health product industries or in government.