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We Are Health Sciences

Regulatory Affairs

Regulatory Affairs (2016-2017)

How to Apply

Program Code

07721

Credential

Program Length

Three semesters, beginning in September

School

We Are Paramedics Caregivers and Nurses

Contact Information

Mojgan Rezvani, program co-ordinator
mojgan.rezvani@humber.ca
healthsciences.humber.ca

Fees/Scholarships

The 2016/2017 fee for three semesters is
– domestic $7,352.01
– international $22,012.50
Amounts listed are the total of tuition, lab and material fees, student service and auxiliary fees for the first three semesters of the 2016/2017 academic year. Fees are subject to change.

Campus/Availability

Start DatesAvailability
2016 SeptemberClosed

Admission Requirements

To be eligible for admission, you must possess the following:
• A Bachelor of Science degree, majoring in health science, pharmacy, some areas in life sciences or a related field.

All applicants whose first language is not English must meet Humber’s English Language Proficiency Policy.

Selection Includes Secondary Requirements: Admission selection is based on the academic criteria indicated and the result of the evaluation of additional secondary requirements. Secondary requirements may include a portfolio, audition, letter of intent, references, etc., and vary by program.

Our Program

Humber’s one-year 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.

List of Courses

How to Apply

Your Career

Our graduates work in a spectrum of fields, such as pharmaceutics, biotechnology, medical devices, natural health product industries or in government.

News

April 25, 2016 - 11:22am

Humber profs awarded for teaching excellence

Four Humber professors have been recognized for their leadership and contributions to the Humber community and beyond. The John and Suanne Roueche...

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