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Regulatory Affairs


Ontario Graduate Certificate


Program Code: 07721

Campus: Online

Length: 3 semesters starting in September

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.

Following two online academic course-based semesters, students complete a three-month (450 hours) work placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Work 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 at placement sites, and assessments are carried out by assigned supervisors at the site of placement. While Humber does assist students in finding their placements by working with industry partners to identify openings, students are responsible for finding their own work placement that is aligned with learning outcomes of our program.

Admission Requirements

Applicants must meet all the requirements below in order to meet minimum program eligibility. Meeting minimum eligibility requirements does not guarantee an offer of admission. Admission decisions will be available via MyHumber, or by email and mail. Admission decisions will not be released by phone.

Admission selection is based on the following 5 requirements:

  • .

    Academic

    To be eligible for admission, you must possess the following:

    • A Bachelor of Science degree, majoring in health science, pharmacy, some area in life sciences or a related field.

    Mature Applicants

    Diplomas and Certificates

    An applicant is considered a mature applicant if they have not completed secondary school or other postsecondary school, and will be 19 or older as of the first day of classes. Humber will invite you for testing to demonstrate that you meet all listed course requirements.

    Degrees

    An applicant is considered a mature applicant if they have not completed secondary school or attended postsecondary studies, and will be 21 or older as of the first day of classes. Mature applicants for degree programs will be required to meet course requirements at the U/M level or equivalent.

    College Transfer Applicants

    Diplomas and Certificates

    An applicant is considered a college transfer applicant if they have completed some or all of a college-level credential. Humber may use a combination of secondary school and/or college courses and grades to determine program eligibility.

    Degrees

    An applicant is considered a college transfer applicant if they have completed some or all of a college-level credential. Humber may use a combination of secondary school and/or college courses and grades to determine program eligibility. Applicants must have an overall minimum grade point average (GPA) of 65 per cent in the program. Applicants are required to disclose and provide academic transcripts for all course work completed at the postsecondary level.

    University Transfer Applicants

    Diplomas and Certificates

    An applicant is considered a university transfer applicant if they have completed some or all of a university-level credential. Humber may use a combination of secondary school and/or university courses and grades to determine program eligibility.

    Degrees

    An applicant is considered a university transfer applicant if they have completed some or all of a university-level credential. Humber may use a combination of secondary school and/or university courses and grades to determine program eligibility. Applicants are required to disclose and provide academic transcripts for all course work completed at the postsecondary level.

  • .

    English Language Proficiency

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

  • .

    International Credit Evaluation

    Canadian citizens or permanent residents with international education are required to provide a WES or ICAS evaluation.

  • .

    Resume

    Applicants must submit a detailed resume including education, work, and/or volunteer experience. Excellent resumes contain experiences that are relevant to the subject of interest. The resume itself should be well organized and easy to follow. Standard Canadian spelling and grammar should be used.

  • .

    Video Introduction

    Applicants must submit a 2-3 minute video introduction outlining their interest in this field of study. The video should express why the applicant has an interest in Regulatory Affairs specifically in Humber College’s Regulatory Affairs graduate certificate program.

    Expectations for Video Introduction

    The video should include the use of clear and concise language that uses appropriate pace, tone, and projection of voice. Hand gestures should be kept to a minimum and when they are used, should add to the presentation style rather than distract.The video must be within the time allowed.

    The video should contain a clear and compelling rationale for the applicant’s interest in the subject. A specific rationale for wanting to study at Humber College should be included and will demonstrate an understanding of the demands of the graduate certificate.

    Submission Instructions

    https://humber.ca/admissions/office-of-the-registrar/registration/submission-instructions.html

How to Apply

Applications are made through ontariocolleges.ca. See program page for details.

International Academic Equivalency

Admission equivalencies for Humber depend on your country of study. Please see admission requirements on the program page to enter your location.

Fees

The 2022-2023 fee for three semesters is:

  • domestic: $7,163.31
  • international: $26,427.00

Fees are subject to change.

Domestic Fees by Semester

Semester 1 2021-22 Fees
Tuition $1,859.15
Compulsory Ancillary Fee $340.39
Compulsory Student Union Fee $64.00
IGNITE Health and Dental Insurance Fee $104.23
Enhanced Student Experience Fee (Optional) $20.00
Program Ancillary Fee $0.00
Co-op/Placement $0.00
Total $2,387.77
Semester 2 2021-22 Fees
Tuition $1,859.15
Compulsory Ancillary Fee $340.39
Compulsory Student Union Fee $64.00
IGNITE Health and Dental Insurance Fee $104.23
Enhanced Student Experience Fee (Optional) $20.00
Program Ancillary Fee $0.00
Co-op/Placement $0.00
Total $2,387.77
Semester 3 2021-22 Fees
Tuition $1,859.15
Compulsory Ancillary Fee $340.39
Compulsory Student Union Fee $64.00
IGNITE Health and Dental Insurance Fee $104.23
Enhanced Student Experience Fee (Optional) $20.00
Program Ancillary Fee $0.00
Co-op/Placement $0.00
Total $2,387.77

International Fees by Semester

Semester 1 2021-22 Fees
Tuition $8,280.38
Compulsory Ancillary Fee $340.39
Compulsory Student Union Fee $64.00
IGNITE Health and Dental Insurance Fee $104.23
Enhanced Student Experience Fee (Optional) $20.00
Program Ancillary Fee $0.00
Co-op/Placement $0.00
Total $8,809.00
Semester 2 2021-22 Fees
Tuition $8,280.38
Compulsory Ancillary Fee $340.39
Compulsory Student Union Fee $64.00
IGNITE Health and Dental Insurance Fee $104.23
Enhanced Student Experience Fee (Optional) $20.00
Program Ancillary Fee $0.00
Co-op/Placement $0.00
Total $8,809.00
Semester 3 2021-22 Fees
Tuition $8,280.38
Compulsory Ancillary Fee $340.39
Compulsory Student Union Fee $64.00
IGNITE Health and Dental Insurance Fee $104.23
Enhanced Student Experience Fee (Optional) $20.00
Program Ancillary Fee $0.00
Co-op/Placement $0.00
Total $8,809.00

*Plus Mandatory Health Insurance fee once per academic year: Fall start - $420 Winter start - $280 Summer start - $140

Equipment & Device Requirements

Semester 1

Details and Specifications Minimum Specifications Recommended Specifications
Processor Intel i5-8300H Intel i5-8300H
OS Windows 10 Windows 10
Memory 8GB of RAM 8GB of RAM
Storage 256GB 256GB
Monitor Laptop Laptop
Other Built-in microphone and webcam, Software: Adobe creative and Microsoft office Suite Built-in microphone and webcam, Software: Adobe creative and Microsoft office Suite

Pathways

Humber offers a number of transfer options and pathway opportunities. Visit humber.ca/transferoptions or refer to the program page.

Contact Information

Michael Lavallee, program co-ordinator
Faculty of Health Sciences & Wellness
416.675.6622 ext. 5301
michael.lavallee@humber.ca

Admissions Questions

Domestic Students

416-675-5000
enquiry@humber.ca

International Students

Contact the International Centre

international.humber.ca/contact

1-416-675-5067

Every attempt is made to ensure that information contained on this website is current and accurate. Humber reserves the right to correct any error or omission, modify or cancel any course, program, fee, timetable or campus location at any time without prior notice or liability to users or any other Person.

On October 21, 2019, the Provincial Government of Ontario announced the renaming of the Ministry of Training, Colleges and Universities (MTCU) to the Ministry of Colleges and Universities (MCU). Both names may appear on this website.

Select information only is included in this printable PDF. For complete program details, refer to humber.ca/programs.

Print/Download Date: August 18, 2022