Regulation of Biomedical Product Commercialization by Health Canada

RGA 6224 4 Quarter Hours
Course Level CPS - Graduate
Description Studies the regulatory requirements associated with all phases of biomedical product commercialization in the Canadian market by manufacturers. The Canadian market represents a significant opportunity for biomedical product manufacturers to export their goods into foreign geographies. Several factors have led patients in Canada to seek treatment modalities for their clinical symptoms and disease from both Canadian and non-Canadian sources. Reviews the Common Technical Document format for market approval applications, general Health Canada Guidances, good manufacturing practices (GMPs), and Global Harmonization Task Force documents. Examines multinational requirements and recommendations, including those issued by the North American Free Trade Agreement, the World Health Organization, and the U.S. Food and Drug Administration. Reviews the requirements of submissions to Health Canada by biomedical product manufacturers.

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
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