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EU Regulatory Acronyms & Definitions, Sixth Edition

  • Gain greater understanding of regulatory throughout the EU with EU Regulatory Acronyms & Definitions, Sixth Edition
  • Essential reference for all regulatory professionals working in the EU market
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Featuring entries selected by RAPS’ EU regulatory experts, EU Regulatory Acronyms & Definitions, Sixth Edition is a handy guide to the industry in the EU.

No matter your area of expertise—biologics, medicinal products, medical devices and more—RAPS helps regulatory professionals translate EU...

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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