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Fundamentals of EU Regulatory Affairs, Seventh Edition

  • 500 pages, 33 chapters
  • Edited by 38 expert authors from around the world
  • Enhanced matrix that clearly explains current regulations
  • Completely new chapters reflecting the changes in medical device regulations

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Fundamentals of EU Regulatory Affairs is the definitive guide to regulatory industry topics in the European Union—from medical devices to pharmaceuticals to biological regulations.

Order your copy of the 7th Edition now to make sure you are up to date with the most current laws and regulations.

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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