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Fundamentals of EU Regulatory Affairs, Seventh Edition (e-book)

  • 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 (e-book) 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 all-new 7th Edition now to make sure you are up-to-date with the most current...

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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