Meeting Details

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RAPS Florida Chapter: Developing Regulatory Affairs Expertise—Key Practices to Increase Knowledge Base
11311 Concept Blvd. Largo, FL 33773
May 23, 2017
8:00 AM - 10:30 AM ET
2.00 RAC
  • List Price: $30.00
  • Member Price: $20.00
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Come engage with professionals from your local regulatory community for breakfast and an interactive presentation on ways to develop your regulatory expertise. This event is coordinated by the RAPS Florida Chapter and is intended to encourage knowledge sharing and community development. Continental...

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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