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2010/11 Programs

Regulatory Affairs

Application Program Code: 07721

Ontario Graduate Certificate
Postgraduate
School of Health Sciences
3 Semesters
2010/11 Availability
North CampusSeptember - CLOSED

Beginning in September

Your Career

In this program, you will learn the specialized knowledge required to help biotechnology, medical device, pharmaceutical, and food companies to manage regulatory processes. Regulatory affairs professionals help businesses ensure that product development, manufacturing, and marketing practices meet or exceed government requirements and are safe for public use.

Graduates of this program enjoy a high percentage employment rate. Work for such employers as Amgen, AstraZeneca, CanReg, CropLife, GSK, Health Canada, Janssen-Ortho, Sanofi-Aventis, and Wyeth.

Our Program

Humber's program is unique in offering in-depth, hands-on learning provided by faculty currently employed in the regulatory affairs environment. As well, the program's Advisory Committee provides constant feedback regarding program development. You will study the international health-care system, health-care legislation, and the procedures and practices for regulating the development, manufacture, quality assurance and marketing of health-care products. Because most companies develop products for an international market, the curriculum covers not only Canadian but also international regulations and guidelines.

More Info

Work Placement

A three-month industry internship lets students apply their skills and knowledge in a real-world work setting. Most internships are in the following sectors: pharmaceutical, biotechnology, medical devices industry, food industry and government.

Admission Requirements

  • A Bachelor of Science degree, majoring in Health Science, Pharmacy, some areas in Life Sciences or a related field. Candidates with a bioengineering background will be considered on an individual basis. Internationally-educated individuals must have the equivalent of a Canadian Bachelor of Science degree. Degrees completed outside of Canada must be evaluated by one of the following - International Credential Assessment Service, University of Toronto Comparative Education Service or World Education Service.
  • Testing in English sentence skills and reading comprehension
  • Additionally, applicants must submit a detailed resumé describing their background (academic and experience), and cover letter with their understanding of the field of regulatory affairs and what they would bring to the field
  • Applicants are rank ordered based on the testing results and the best qualified are invited in for an interview/ information session where the final selection is made for admission into the program.

Note: Refer to the Selection Procedures section for more information

Meeting the minimum requirements does not guarantee admission to the program.

Fees

The 2010/2011 fee for three semesters is
- domestic $5,649.08
- international $11,730.

For further information, refer to Fees and Financial Assistance in this publication.

Financial Aid

Curriculum

Semester 1
COURSE Code Course Credits
REGA 500 Health-Care Legislation, Regulations and Guidelines 4
REGA 502 Health-Care Product Development 3
REGA 503 Provincial Formularies and Reimbursement Policy 2
REGA 505 Biotechnology 3
REGA 508 Negotiation Skills for Regulatory Affairs 2
REGA 510 Medical Devices 3
REGA 512 Scientific and Technical Writing 1
REGA 513 Regulations of Agrichemicals 1
Semester 2
COURSE Code Course Credits
REGA 501 Information Technology 1
REGA 504 Recent Trends in Therapeutics 4
REGA 506 Regulatory Submissions 4
REGA 507 Post-Marketing Compliance 2
REGA 509 International Regulations and Initiatives 4
REGA 511 Overview of Regulatory Affairs Industry 2
REGA 514 Regulations of Agricultural Biotechnology and Food Products 1

Semester 3
COURSE Code Course Credits
REGA 515 Work Experience 4  
REGA 516 Integrative Seminar 1  
  Hours/week: 35   

			      		

		

	              
      
      

	

	
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