TIPT Academic Programs
Pharmaceutical Regulatory Affairs
Credential Awarded: Ontario Post-Graduate Diploma
( Dip.Pharm RA)
Program Duration: Approx. 28 Weeks
Start Dates: January 30, April 24, June 19, September 18
Schedule: Mon – Thu: 9:00am – 3:30pm, Fri: 9:00am – 2:00pm
Your Career Option
In this program, you will learn and acquire specialized knowledge and practical skills required to function as a Pharmaceutical Regulatory Affairs professional in the pharmaceutical, biotechnology, medical devices, food, cosmetics, natural product, nutraceutical and other life-science industries. Pharmaceutical Regulatory Affairs professionals responsible for developing, compiling, and filing documentation required to support the licensing and approval of pharmaceutical drugs. They are involved in active liaison with regulatory authorities such as the Canadian Therapeutic Products Directorate (TPD) and the US Food and Drugs Administration (FDA). The success of the Company is invariably dependent on the accuracy and efficiency of drug submissions Graduates of this program enjoy a high percentage employment rate and work for both multinational and generic company employers such as GSK, Apotex, Biovail, Teva, Patheon, Novopharm, AstraZeneca, Pharmascience, Amgen, and Taro pharmaceuticals. They also find employment in biopharmaceutical, biotechnology and advanced-drug delivery companies.
The program entails an intensive series of learning modules developed to enable a practical understanding of the regulatory approval and communication processes involving pharmaceutical and biotechnology drugs as well as natural health products and medical devices. While the primary emphasis is on regulatory affairs as it applies in North America under the Canadian Health Products and Food Branch (HPFB) and the US Food and Drugs Administration (FDA), the regulations in other major jurisdictions such as Europe, Japan and Australia will also be covered. You will acquire knowledge of international health care system, health care legislation, procedures and practices for regulating the development, manufacture, quality assurance and marketing of health care products.
Practical Experience (Integrated Co-op)
A unique and highly successful aspect of our program is our hands-on approach provides the opportunity for students to apply and integrate their knowledge in a "real-world" work setting under TIPT's IPE system. You will receive practical experience with actual submissions that have been approved by regulatory authorities. Throughout the program, various practical projects expose the student to pharmaceutical industry submissions and lets students apply their skills and knowledge in a real-world work setting.
- A Bachelor of Science degree, majoring in general science, Biological, Applied or Health Science, Chemistry, Pharmacy, some areas in Life Sciences or a related field. A GPA average of C+ is recommended.
- 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.
- Meeting the minimum requirements does not guarantee admission to the program.