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Virtual Program: Understand the New EU Medical Device/IVD Regulations (4-part series)
Location:
Online
Date:
May 3-24, 2017

This program draws together industry experts and leading notified bodies who have been closely following the evolution of the proposed regulations, anticipating the final texts, developing positions on what will be required by the regulations, and understanding the impact on manufacturers, devices and systems both new and legacy.

  • List Price: $600.00
  • Member Price: $525.00
 
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Wednesdays 3, 10, 17 and 24 May 2017
11:00 am–1:00 pm EDT

Register For Series

Register for Individual Sessions:

Week 1 – Background to New EU Regulations
Week 2 – EU MDR Requirements
Week 3 – EU IVDR Requirements
Week 4 – Technical Documentation, Postmarket and Other

Program Description

The European...

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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