Meeting Details

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    • Event Details
RAPS Vancouver Chapter: An Update from Health Canada’s Medical Devices Bureau
Terminal City Club
837 West Hastings Street Vancouver BC V6C 1B6 Canada
March 16, 2017
5:30 PM - 7:30 PM PT
2.00 RAC
  • List Price: $70.00
  • Member Price: $55.00
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The RAPS Vancouver Chapter invites you to come engage with colleagues from the local, national and international regulatory communities for an interactive session on new developments in the medical devices program at Health Canada. Don’t miss this unique opportunity to hear directly from Kimby...

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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