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Regulatory Affairs

Credential: Ontario Graduate Certificate Program Code: 07721 Length: 3 semesters

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.

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. Meeting minimum eligibility requirements does not guarantee an offer of admission.

 

Date Location Availability International Student Availability
September 2017NorthOpenOpen

The 2016/2017 fee for three semesters was:

  • domestic $7,352.01
  • international $22,012.50.

Amounts listed were 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.

Fees by Semester >

Scholarships

Humber offers a variety of scholarships each year.

Learn more >

Program Contact(s)

Mojgan Rezvani
Program Co-ordinator
416.675.6622 ext. 5253
mojgan.rezvani@humber.ca

Admissions

Domestic Students

North Campus
Humber Learning Resource Commons, 1st Floor
416-675-5000

Lakeshore Campus
WEL 106
416-675-5000

enquiry@humber.ca

 

International Students

Phone 1-416-675-5067
Fax 1-416-675-6386
international@humber.ca

 

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Apply to Humber

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.

Admission 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 >

In order to continue with your application for Clinical Regulatory Affairs, you must complete this step in the application process. Applicant selection is based on academic criteria and results of these secondary requirements. This contains all the information you need to prepare and submit secondary requirements for consideration. If you have any questions, please contact Admissions using the email address or phone number on this page.

Secondary Requirements

Applicants are required to submit a case study and attend an interview.

i. Case Study

Applicants must submit a 500-750-word case study that will outline their understanding the profession.

“You are a current student in the postgraduate certificate program Regulatory Affairs. Your neighbour has approached you regarding his wife. She has recently been diagnosed with thyroid cancer. One of the options she has been given for treatment is a new drug that she would receive by participating in a clinical trial. They are hoping you can help them make a decision and have a few questions for you.

  • When new drugs are tested on humans what are the potential benefits and harms for patients associated with such testing?
  • Is the government overseeing use of drugs which are in a testing stage? If yes, is there any benefit for society from such overseeing?
  • What is the role of a Regulatory Affairs Specialist? Where in the industry do they work?
  • What does regulatory affairs mean?

ii. Interview

Applicants must attend an interview where they will be asked specific questions about their case study submission.

Submission Instructions for Case Study

Applicants must submit the case study through SlideRoom. SlideRoom is a secure site where secondary requirements are collected, scored and stored. Log-in to https://humber.slideroom.com and create your free account. There will be additional instructions once your account has been created.

Registration Instructions for Interview

Applicants must register to attend this admissions event. Log-in to MyHumber to register:

  1. Log-in to MyHumber
  2. Select the Applicant tab
  3. Select the Applied Programs tab
  4. Select your Year and Applicant Number from the drop-down menu, then click Submit
  5. Click on “Do I Have Any Missing Requirements”
  6. Click on “Go to Events” (located under the “Link” section, near the bottom right of the page)
  7. Choose from a list of available assessment dates and follow the prompts

Applicants must meet both academic and secondary requirements in order to meet minimum program eligibility. Meeting minimum eligibility does not guarantee an offer of admission.

All secondary requirements will be evaluated and a score will be calculated by the academic school.

Admission decisions will be available via MyHumber, or by email and mail. Admission decisions will not be released by phone.

Fees by Semester 

 

Semester 1 Domestic Fee International Fee*
Total $2,450.67 $7,212.50
Tuition $1,947.16 $6,708.99
Mandatory Non-Tuition $503.51 $503.51
Lab/Materials $0.00 $0.00
Co-op/Placement    

 

 

Semester 2 Domestic Fee International Fee*
Total $2,450.67 $7,212.50
Tuition $1,947.16 $6,708.99
Mandatory Non-Tuition $503.51 $503.51
Lab/Materials $0.00 $0.00
Co-op/Placement    

 

Semester 3 Domestic Fee International Fee*
Total $2,450.67 $7,212.50
Tuition $1,947.16 $6,708.99
Mandatory Non-Tuition $503.51 $503.51
Lab/Materials $0.00 $0.00
Co-op/Placement    

*Plus Mandatory Health Insurance fee once per academic year: Fall start - $375 Winter start - $250 Summer start - $125

 

Our Program

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.


Close

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.

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 in 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.