Meeting Details

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RAPS DC/Baltimore Chapter and Johns Hopkins AAP: Sixth Annual Mid-Atlantic Regulatory Career Day
Location:
Johns Hopkins University Rockville Campus
9605 Medical Center Drive Rockville, MD 20850
Date:
May 13, 2017
Time:
9:30 AM - 4:00 PM ET
  • List Price: $45.00
  • Member Price: $30.00
 
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Join your regulatory, quality and compliance colleagues from the east coast for the Sixth Annual Mid-Atlantic RAPS Chapter and Johns Hopkins AAP Mid-Atlantic Career Day at the Johns Hopkins Montgomery County Campus. This inventive workshop is designed to help you get started or advance your career...
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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