Meeting Details

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RAPS Twin Cities Chapter: An Update on Global Regulations
Location:
Saint Cloud State University At Plymouth
9750 Rockford Road Plymouth, MN 55442
Date:
May 11, 2017
Time:
5:30 PM - 8:30 PM CT
Credits:
2.00 RAC
  • List Price: $45.00
  • Member Price: $30.00
 
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Come join colleagues from your local regulatory community for an evening of networking and to hear two presentations on global regulations. This event is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Dinner will be...

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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