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MDBT605

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Advancing Innovation: The Role of Regulatory Affairs

Graduate Science Education (O) MD - Cumming School of Medicine

Subject

MDBT - Medicine Biomedical Technology

Description

Explores the importance of regulatory strategy and how regulatory decisions can impact the overall strategic direction of a business. Students will learn through real life examples and case studies, with a focus on biopharmaceuticals, medical devices, health tech and diagnostics/tools. An emphasis will be placed on Health Canada, the US Food and Drug Administration, the European Medicines Agency, and the Medicines and Healthcare products Regulatory Agency (United Kingdom). Students will gain an understanding of the regulatory requirements needed for the development and commercialisation of products, case studies, and group presentations.

Prerequisite(s): Admission to the Master of Biomedical Technology program.

Also known as: (formerly Medical Graduate Education 605)

Course Attributes

GFC Hours (12 HOURS), Fee Rate Group(Domestic) - A, Fee Rate Group(International) -B

Courses may consist of a Lecture, Lab, Tutorial, and/or Seminar. Students will be required to register in each component that is required for the course as indicated in the schedule of classes. Practicums, internships or other experiential learning modalities are typically indicated as a Lab component.

Component

LEC

Units

1

Repeat for Credit

No

Subject code

MDBT
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