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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This book is currently out of stock. We apologize for any inconvenience. Order now and get the e-book version at no additional cost. The e-book will automatically be added to your order during checkout and can be accessed immediately. Your hardcover book will be shipped once back in stock.
>> View Table of Contents>> Author Acknowledgments
This critical resource includes all the pharmaceutical and biologics chapters from RAPS’ four Fundamentals of Regulatory Affairs books, covering the US, EU, Canada, and international. This highly focused compilation looks in-depth at requirements throughout the product lifecycle, from R&D through postmarketing. It is an excellent guide to finding answers on pharmaceutical and biologics regulations, learning about the industry, and as a study tool for the RAC (Drug) Exam.
Here's what you get in the Fourth Edition:
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RAC Exam questions are updated after the Spring testing cycle every year to reflect current regulations, guidelines and practice. New examination content is added before the Summer testing cycle and covers regulations in effect as of 31 December of the previous year.
Take a look at our RAC prep resources
Published by RAPS © 2021. Hardcover. Two Volumes. 1,524 pages. ISBN: 978-1-947493-69-8.