Meeting Details

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RAPS San Francisco Bay Area Chapter: MDR and IVDR: Ready, Get Set, Go!
Location:
Crowne Plaza San Jose - Silicon Valley
777 Bellew Dr Milpitas, CA 95035-7900
Date:
June 9, 2017
Time:
7:30 AM - 4:45 PM PT
Credits:
6.00 RAC
  • List Price: $200.00
  • Member Price: $175.00
 
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On 5 April 2017, the European Parliament voted to adopt the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), the final step before the regulations are formally published in the Official Journal of the European Union in May. The deadlines to comply with the new...

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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