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Fundamentals of EU Regulatory Affairs, Eighth Edition

The eighth edition of Fundamentals of EU Regulatory Affairs updates readers on the current regulatory environment in the Union, including the latest information on the new medical device and in vitro device regulations, developments in implementation of the clinical trial regulation and a number of other new topics.

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Item Details:
The information in this publication is current to September 2017, including pending changes to legislation.

This edition of Fundamentals of EU Regulatory Affairs focuses on changes to healthcare product development, manufacturing and marketing across the EU. The most significant changes since the...

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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