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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.
Graduates of this program are qualified for a career as:
- Regulatory Affairs Associate
- Regulatory Affairs Specialist
- Regulatory Affairs Officer
- Technical Writer
- Documentation Specialist
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. Successful applicants MUST possess above average writing and communication skills
- 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.
- All applicants are required to submit a one-page hand-written scientific summary on a given topic.
The foundation module is designed to provide a general overview background in regulatory sciences such as the medical and biopharmaceutical concepts and introduce new concepts in pharmaceutical Regulatory Agencies, Regulatory Affairs, and Clinical Trials.
This module provides training in pharmaceutical regulatory affairs including GMP, technical writing, documentation and project management required for a success career. Emphasis will be placed on IND/NDA/NDS/ANDA/BLA.
Industry based projects mimicking regulatory affairs careers including the development of protocols and standard documentation requirements for the pharmaceutical industry.
Examination & Continuous Assessment
Written, oral and practical examinations are mandatory at the end of the foundation and core modules. In the advanced module, assessment is based on dissertation and viva-voce. In addition, the overall grade is also based on continuous assessments encompassing GMP and GLP compliance, pharmaceutical documentation skills and interim quizzes.
A diploma in Pharmaceutical Regulatory Affairs is awarded upon successful completion of all three modules.