Meeting Details

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RAPS Wisconsin Chapter: The EU Medical Device Regulation (MDR): Ten Steps to Certification
GE Healthcare Research Park
9900 W Innovation Dr Wauwatosa, WI 53226-4856
April 26, 2017
5:30 PM - 8:00 PM CT
1.00 RAC
  • List Price: $55.00
  • Member Price: $40.00
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Join regulatory colleagues from your region for an evening of networking and an expert presentation on the EU Medical Device Regulation.

Medical device manufacturers are facing major changes in the EU regulatory framework that oversees market access to Europe. This presentation will provide an...

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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