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.
Type : Full Time
Level : Diploma
Duration : 10 Months
Tuition Fees : Not Available
Eligibility : A Bachelor's degree ( BA or BSc) or Two year College Technology Diploma
Accreditations : Program is postgraduate diploma registered and approved by the Ministry of Training, Colleges and Universities of Ontario, Canada
Salient Features : 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.