Regulatory Affairs
Ontario Graduate Certificate
Program Code: 07721
Campus: Downtown (IGS), Online
Length: 3 semesters
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 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 Options:
Fall Intake: Courses are scheduled over two 14-week semesters and offer a blend of self-directed online modules and synchronous online classes. A field experience occurs in Semester 3 and is in-person. This offering is unavailable to international students.
Winter Intake: Courses are scheduled over two 14-week semesters, and classes are a mix of in-person at the International Graduate School campus, self-directed online modules and synchronous online classes. This offering is open to domestic and international students.
Following two academic course-based semesters, students complete a three-month (450 hours) that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Field experiences 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 Semester 3, students complete their learning at field experience sites, and assessments are carried out by assigned supervisors at the site of the field experience. While Humber does assist students in finding their field experience by working with industry partners to identify openings, students are responsible for finding their own field experience that is aligned with learning outcomes of our program.
Courses
Semester 1 |
|---|
| RARC 5000: |
| RARC 5001: |
| REGA 5022: |
| REGA 5023: |
| REGA 5025: |
Semester 2 |
|---|
| RARC 5500: |
| REGA 5021: |
| REGA 5034: |
| REGA 5035: |
| REGA 5037: |
| REGA 5041: |
Semester 3 |
|---|
| REGA 5040: |
Admission Requirements
Admission selection is based on the following 3 requirements:
- .
Academic
To be eligible for admission, you must possess the following:
- A Bachelor of Science degree or equivalent, 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 credential evaluation. Note, for international High school education course by course evaluations, ICAS must be used. For international post-secondary education, a WES evaluation must be provided. In situations where you expect to apply for transfer credit, it is recommended that a course by course WES evaluation is completed.
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 2024/2025 fee for three semesters is:
- domestic: $7,501.08
- international: $28,183.32
Fees are subject to change.
Domestic Fees by Semester
| Semester 1 | 2021-22 Fees |
| Tuition | $1,859.15 |
| Compulsory Ancillary Fee | $444.09 |
| Compulsory Student Union Fee | $66.00 |
| IGNITE Health and Dental Insurance Fee | $111.12 |
| Enhanced Student Experience Fee (Optional) | $20.00 |
| Program Ancillary Fee | $0.00 |
| Co-op/Placement | $0.00 |
| Total | $2,500.36 |
| Semester 2 | 2021-22 Fees |
| Tuition | $1,859.15 |
| Compulsory Ancillary Fee | $444.09 |
| Compulsory Student Union Fee | $66.00 |
| IGNITE Health and Dental Insurance Fee | $111.12 |
| Enhanced Student Experience Fee (Optional) | $20.00 |
| Program Ancillary Fee | $0.00 |
| Co-op/Placement | $0.00 |
| Total | $2,500.36 |
| Semester 3 | 2021-22 Fees |
| Tuition | $1,859.15 |
| Compulsory Ancillary Fee | $444.09 |
| Compulsory Student Union Fee | $66.00 |
| IGNITE Health and Dental Insurance Fee | $111.12 |
| Enhanced Student Experience Fee (Optional) | $20.00 |
| Program Ancillary Fee | $0.00 |
| Co-op/Placement | $0.00 |
| Total | $2,500.36 |
International Fees by Semester
| Semester 1 | 2021-22 Fees |
| Tuition | $8,753.23 |
| Compulsory Ancillary Fee | $444.09 |
| Compulsory Student Union Fee | $66.00 |
| IGNITE Health and Dental Insurance Fee | $111.12 |
| Enhanced Student Experience Fee (Optional) | $20.00 |
| Program Ancillary Fee | $0.00 |
| Co-op/Placement | $0.00 |
| Total | $9,394.44 |
| Semester 2 | 2021-22 Fees |
| Tuition | $8,753.23 |
| Compulsory Ancillary Fee | $444.09 |
| Compulsory Student Union Fee | $66.00 |
| IGNITE Health and Dental Insurance Fee | $111.12 |
| Enhanced Student Experience Fee (Optional) | $20.00 |
| Program Ancillary Fee | $0.00 |
| Co-op/Placement | $0.00 |
| Total | $9,394.44 |
| Semester 3 | 2021-22 Fees |
| Tuition | $8,753.23 |
| Compulsory Ancillary Fee | $444.09 |
| Compulsory Student Union Fee | $66.00 |
| IGNITE Health and Dental Insurance Fee | $111.12 |
| Enhanced Student Experience Fee (Optional) | $20.00 |
| Program Ancillary Fee | $0.00 |
| Co-op/Placement | $0.00 |
| Total | $9,394.44 |
*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 (PC) 4-core or higher 64bit (Mac) |
Intel i5-8300H (PC) 4-core or higher 64bit (Mac) |
| OS | Windows 10 (PC) OS 10.15 (Mac) |
Windows 10 (PC) OS 10.15 (Mac) |
| 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
Shyam Mohamed
, program co-ordinatorFaculty of Health Sciences and Wellness
416.675.6622 ext. 4566
shyam.mohamed@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.
Select information only is included in this printable PDF. For complete program details, refer to humber.ca/programs.
Print/Download Date: January 11, 2025