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RAPS Texas Chapter: Communicating Benefit-Risk Is Fundamental to Device Approval and Market Adoption
Emergo Group Headquarters
2500 Bee Cave Road, Building One Conference Room Austin, TX 78746
May 17, 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 communicating benefit-risk analysis seeking approval of a medical device. This event is coordinated by the RAPS Texas Chapter and is intended to encourage knowledge sharing and...

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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