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Fundamentals of Canadian Regulatory Affairs, Fourth Edition

  • Establish your expertise in the Canadian regulatory market with RAPS’ Fundamentals of Canadian Regulatory Affairs, Fourth Edition
  • Recently updated and expanded to cover topics of increasing importance across Canada

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With the world of technology, health and medicine changing daily, regulatory professionals require a reference resource that stays on the competitive-edge of the industry. For regulatory pros working on products for the Canadian market, there’s no better resource than RAPS’ Fundamentals of Canadian...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design