Regional Regulations - Canada

Pharmaceuticals: Canadian Regulations
Available

This course will introduce a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada. Topics covered include the organization of Health Canada, Good Manufacturing Practices (GMPs), submissions, patent listing, labeling, advertising and promotion and postapproval changes.

Fundamentals of Canadian Regulatory Affairs, Third Edition
Available
A comprehensive reference text that includes essential information for regulatory professionals working with healthcare products for the Canadian market

Medical Devices: Canadian Regulations
Available

This course covers a wide range of issues from the regulatory framework provided by Health Canada, through the steps to submit an investigational testing application or a medical device licence application, to postmarketing activities. It will discuss classification of devices, selection of the appropriate license type, submission requirements, quality systems and postmarketing requirements.