Back to On-demand Program: Understand the New EU Medical Device/IVD Regulations (Part 4)
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On-demand Program: Understand the New EU Medical Device/IVD Regulations (Part 4)

An on-demand recording of the RAPS Virtual Program, Understand the New EU Medical Device/IVD Regulations (Part 4), originally recorded in May 2017.


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Program Description

The European Commission published proposals for new regulations of medical devices and in vitro diagnostics in 2012. Now, after years of negotiation within the EU legislative system and with interested stakeholders, the new regulations are expected to be published in 2017. This...

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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