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RAPS Vancouver Chapter: Developing Regulatory Affairs Expertise—Key Practices to Increase Knowledge Base
LifeScan Inc.
210-4321 Still Creek Drive Burnaby BC V5C 6S7 Canada
December 5, 2017
5:30 PM - 8:00 PM PT
2.00 RAC
  • List Price: $40.00
  • Member Price: $25.00
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In today’s competitive market, regulatory professionals need regulatory and business insight to provide more value on project teams and achieve smoother agency reviews. But developing quality experience and expertise in regulatory is not solely based on the time spent compiling regulatory...

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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