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Regulatory Affairs

Humber College - North
Canada, Ontario, Toronto
Tuition fee CA$25,330 per program

The fees shown here are estimates only for three semesters and are subject to change. The above fee includes tuition (CA$23,376), health insurance and ancillary fees.

Please REVIEW the Humber College`s refund/deferral policy.

Registration fee CA$375 one-time

The registration fee includes the non-refundable application fee (CA$75) and the refundable deposit fee (CA$300).

Please REVIEW the EdviseCanada`s fee policy.

More information

healthsciences.humber.ca/..s-graduate.html 

Overview

Humber’s Regulatory Affairs graduate certificate program prepares graduates with the transferable skills needed to build successful careers in a variety of sectors requiring regulatory affairs expertise and training. This 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.

You will also benefit from:

  • two academic semesters
  • a subsequent third-semester internship placement carried out post-academic semesters
  • case studies and projects mimicking real work experiences
  • integrative project work that links applied and academic fields
  • acquiring a recognized skillset applicable to a wide variety of employment opportunities
  • learning to adapt to the changing field and stay current

Work Placement

Following two academic course-based semesters, students complete a three-month (450 hours) internship work placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Internship placements are conducted in a wide range of organizations such as pharmaceutical, natural health products (NHP), medical device and biotechnology companies, as well as contract research organizations, hospitals, government agencies/departments and scientific institutions.

To progress into Semester 3, students must have successfully completed the first two semesters. During Semesters 3, students complete their learning on placement sites, and assessments are carried out by assigned supervisors at the site of placement. Humber assists students in finding their placements by working with our industry partners to identify openings. Students are responsible for finding their own work placement that is aligned with the learning outcomes of our program.

Career opportunities

Graduates of this program typically pursue careers in the regulatory affairs departments that exist in pharmaceutical, medical devices, biotechnology, consulting, inspection, quality assurance, research institutes, government agencies, and any related industry or sector that requires regulatory expertise.

Apply Now! September 2023
Application start
Oct 3, 2022
This intake is not applicable
Studies commence
Sep 5, 2023

Application deadlines apply to citizens of: United States

Apply Now! September 2023
Application start
Oct 3, 2022
This intake is not applicable
Studies commence
Sep 5, 2023

Application deadlines apply to citizens of: United States