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RAPS New York/New Jersey Chapter: US Regulatory Affairs Certification (RAC) Exam Overview
Hyatt House Bridgewater
530 Route 22 Bridgewater, NJ 08807-2405
March 11, 2017
8:00 AM - 5:00 PM ET
  • List Price: $125.00
  • Member Price: $75.00
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Saturday, 11 March 2017
8:00 am–5:00 pm EST
Hyatt House Bridgewater
Bridgewater, NJ

Are you thinking about taking the Regulatory Affairs Certification US exam? If so, join others from the New York/New Jersey regulatory community for a full day session that will help you prepare for the April/May 2017...

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» View the Table of Contents

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