Fundamentals of Regulatory Affairs Series

Fundamentals of EU Regulatory Affairs, Eighth Edition

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 introduction of the Medical Devices Directive are coming with the implementation of the EU Medical Device Regulation and EU In Vitro Diagnostic Device Regulation. Clinical trial regulations implementation has been delayed, but its impact is discussed. There are several new chapters in this edition, covering EMA and other EU regulatory bodies, preparing for EMA meetings, regulatory strategy, medical device preclinical testing, adaptive and alternative medicinal product pathways and more. This book is an excellent reference for anyone at any level working in regulatory affairs in the EU market and a useful tool for those planning to sit for the RAC (EU) exam. 

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Fundamentals of EU Regulations Sector-Specific Series

Get the information you need and want, and nothing more. Now the newest Fundamentals of EU Regulatory Affairs comes in subset volumes on either medical devices or pharmaceutical and biologics. Choose exactly what you need—on the topic that pertains to you.


Fundamentals of US Regulatory Affairs, 10th Edition

For 20 years, our flagship publication, Fundamentals of US Regulatory Affairs, has been giving regulatory professionals the insights and answers they need, right at their fingertips. Introducing the 10th edition of Fundamentals of US Regulatory Affairs, the cornerstone of a good regulatory library.

Navigate the complexities of the requirements and guidance's of healthcare product regulation in one comprehensive resource. What’s new in the book:

  • More than 50 subject matter experts contributed to provide updates through May 2017
  • More detail on topics like preclinical trials and Good Laboratory Practices, and clinical trials and Good Clinical Practices, breaking these subjects down by product lines
  • New chapters on traceability and supply chain, and biosimilars
  • Easy to use matrix of applicable laws and regulations by product and lifecycle stage, plus a useful glossary and detailed index
  • Convenient, fully searchable e-book available on updated e-book reader

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Fundamentals of US Regulations Sector-Specific Series


Fundamentals of International Regulatory Affairs, Third Edition

This third edition is updated with developments through 2016 and delves more deeply into specific countries and regions than previous editions. It covers the full gamut of regulated healthcare products. Also available, Fundamentals of International Regulations sector-specific series.

Titles Available Now:

    Entire Fundamentals of Regulatory Affairs Series

    The Fundamentals series provides a global perspective on regulatory practices, with books on Canada, EU and the rest of the world, as well as publications focused on pharmaceuticals, biologics and medical devices.

      2017-US-Fundamentals-webpage-US     EU Fundamentals of Regulatory Affairs - Order Now   Canadian Fundamentals of Regulatory Affairs - Order Now
    2017-Fundamentals-webpage-int (002)   Global Medical Device Regulation - Order Now Global Pharmaceutical Regulation - Order Now