Meeting Details

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RAPS Atlanta Chapter: RAPS 2017 Southeast Region Regulatory Career Day
Location:
Georgia Institute of Technology, Parker H. Petit Institute
315 Ferst Dr NW Atlanta, GA 30332-0001
Date:
March 30, 2017
Time:
1:00 PM - 7:00 PM ET
  • List Price: $40.00
  • Member Price: $30.00
 
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Resolutions and goal setting cross everyone’s mind when a new year begins. If one of your to-do list items for 2017 is to seek opportunities in regulatory affairs, register today for the 2017 Southeast Region Regulatory Career Day. On 30 March 2017, Georgia Institute of Technology will host this...

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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