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 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.
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. |
These courses are intended as guidelines. Speak to your guidance counsellor to see what courses are offered at your school.
Applicants must have 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. |
* We make every attempt to provide accurate information on prerequisites, programs, and tuition. However, this information is subject to change without notice and we highly recommend that you contact the school to confirm important information before applying.
