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RAPS Texas Chapter: EU In Vitro Diagnostic Device Regulation—Are You Prepared for the Changes?
Emergo Group Headquarters
2500 Bee Cave Road, Building One Conference Room Austin, TX 78746
July 20, 2017
6:00 PM - 8:00 PM CT
1.50 RAC
  • List Price: $45.00
  • Member Price: $30.00
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Come engage with professionals from your local regulatory community over dinner and hear an interactive presentation on the new EU In Vitro Diagnostic Device Regulation (IVDR) in the European Union. This event is coordinated by the RAPS Texas Chapter and is intended to encourage knowledge sharing...

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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