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Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations

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Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations

Item Details: 

This is a compilation of two books RAPS published in 2018: Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations. 

It is the result of a collaboration among RAPS, officials from Health Canada and the Canadian Association of Professionals in Regulatory Affairs (CAPRA), and presents the current Canadian regulatory environment for pharmaceutical and biologic products, medical devices and in vitro diagnostics. 

Among the topics covered:

  • Health Canada 
  • Preclinical and clinical testing, investigational testing and the Special Access Programme
  • Submission and approval
  • Postmarketing activities and requirements
  • Device classification
  • GxPs
  • Labeling, advertising and promotion
  • Lifecycle regulations and guidances 

A comprehensive index for each section is included.

Who Should Use This Publication?

Fundamentals of Canadian Pharmaceutical, Biologic and Medical Device Regulations was written by regulatory professionals for regulatory professionals. It is an excellent reference book for both those new to the field and seasoned professionals who need to check on an unfamiliar topic. 
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