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Regulatory Affairs

Credential: Ontario Graduate CertificateProgram Code: 07721Length: 3 semestersProgram Starting Between:  

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 program eligibility.

    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 3-5 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 gradate certificate.

    Submission Instructions

INTERNATIONAL ACADEMIC EQUIVALENCY

Admission equivalencies for Humber depend on your country of study. Please enter your location or choose detect my location to see the requirements for your country below.

Post-Admission Requirements

Once you have been accepted, and have confirmed your offer, you may need to complete a further set of requirements related to your program (Post-Admission Requirements).

Not available

Fees

The 2018-2019 fee for three semesters was:

  • domestic: $7,576.53
  • international: $23,866.50

Fees are subject to change.

Scholarships

Humber offers a variety of scholarships each year.

Learn more >

Fees by Semester 

Fees by Semester

Semester 1Domestic FeeInternational Fee*
Total$2,525.51$7,815.50
Tuition$2,065.73$7,355.72
Mandatory Non-Tuition$459.78$459.78
Lab/Materials$0.00$0.00
Co-op/Placement$0.00$0.00

 

Semester 2Domestic FeeInternational Fee*
Total$2,525.51$7,815.50
Tuition$2,065.73$7,355.72
Mandatory Non-Tuition$459.78$459.78
Lab/Materials$0.00$0.00
Co-op/Placement$0.00$0.00

 

Semester 3Domestic FeeInternational Fee*
Total$2,525.51$7,815.50
Tuition$2,065.73$7,355.72
Mandatory Non-Tuition$459.78$459.78
Lab/Materials$0.00$0.00
Co-op/Placement$0.00$0.00

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

Pathways

Pathways are academic routes that students can take to move from one credential to another.

TRANSFER OPTIONS

Can't find a pathway? You can still get the credit you deserve from your previous education or your prior work or life experience.

Learn more >

Contact Us

Program Specific Questions

Mojgan Rezvani, program co-ordinator
416.675.6622 ext. 5253
mojgan.rezvani@humber.ca
healthsciences.humber.ca

Admissions Questions

Domestic Students  

Phone: 416-675-5000
Email: enquiry@humber.ca

International Students  

Contact the International Centre

How to Apply

Applications to Humber are made through ontariocolleges.ca. Be sure to submit your application by the equal consideration deadline of February 1. You may apply after February 1, however, post-February 1 applications will be considered on a first-come, first-served basis depending on the availability of the space in the program. To check program availability refer to the Campus/Availability listing on Humber's program pages or ontariocolleges.ca.

Admissions Road Map >

Apply through Ontario Colleges >

INTERNATIONAL STUDENTS

If you’re an international student, you can apply directly to Humber via our International Centre.

Apply through the International Centre >

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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.

Courses Learning Outcomes

Upon successful completion of the program, a graduate will:

  • Describe the government processes within the Canadian health care system and provincial formularies.

  • Explain the roles and responsibilities of a regulatory professional in industry.

  • Explain the concepts in pharmacoeconomics as they relate to the socioeconomic aspects of health care and health care products.

  • Explain Canadian and international health care legislation and regulations including (as examples) Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, Good Documentation Practices, International Standards Organization (ISO), Food and Drug Act Regulations, the Environmental Protection Act, Regulatory compliance/inspection, Drug Establishment Licensing and related standards and guidelines.

  • Describe international harmonization of regulations and the impact on manufacturing and the submission process.

  • Explain the Product Development Process.

  • Outline the Quality Control Process.

  • Demonstrate information technology skills in the use of software applicable to regulatory affairs submissions, in document and database management systems, in data correction techniques and in the use of the Internet for research.

  • Define drug (prescription and non-prescription)/medical device/biologic submission process requirements.

  • Prepare a drug/medical device/biologic submission to the Therapeutic Products Program (TPP) including supplemental documentation.

  • Demonstrate the problem solving process as it relates to pharmacovigilance and post-marketing surveillance.

  • Demonstrate effective interviewing and negotiating skills in managing a clinical study.


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Work Placement

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.

Program Availability

START DATE LOCATION STATUS INTERNATIONAL STATUS
September 2019NorthOpenOpen

The Humber Advantage 

Industry Recognition

Every year our program receives excellent feedback from the industry regarding the professional preparation of the graduates and the content of the program; our graduates are an important resource for the industry. This is an outcome of our ongoing efforts to ensure that students have a solid regulatory affairs, science, and medical knowledge.

In the Industry

Regulatory Affairs Specialists help the government and businesses to ensure that product development, manufacturing, and marketing practices meet government standards and ensure products are safe for public use.

An Education in High Demand

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.

Your Career

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

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 June 29, 2018, the Provincial Government of Ontario announced the renaming of the Ministry of Advanced Education and Skills Development (MAESD) to the Ministry of Training, Colleges and Universities (MTCU). Both names may appear on this website.