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RAPS Wisconsin Chapter: Chapter Meet Up and Highlights from RAPS’ 2017 Regulatory Convergence
Water Street Brewery - Lake Country
3191 Golf Rd Delafield, WI 53018-2156
November 30, 2017
5:30 PM - 8:00 PM CT
1.00 RAC
  • List Price: $10.00
  • Member Price: $5.00
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Join colleagues from your local regulatory community for a networking “Meet-Up” and to hear highlights from the 2017 RAPS Regulatory Convergence. Attendees from this year’s Convergence will share what they learned from many of the educational sessions and keynote speakers, including FDA...

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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