Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition

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Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition

Table of Contents


Contributing Authors

Product Description

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.

Who should buy this book?

Fundamentals of Medical Device Regulations, Fifth Edition was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework including newcomers and seasoned professionals as well as academics and governmental employees. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant medical device regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a valuable resource to facilitate strategic discussions on medical device regulations and policy worldwide.

This is an outstanding reference for individuals working in multinational product development and marketing at all levels, from seasoned regulatory personnel who need to check facts or are dealing with a new product type to those new to the profession. It also is a handy study tool for those planning to sit for the Regulatory Affairs Certification (RAC) exam, in addition to professional experience, training, and other resources.
Daniel G. Mannix, PhD
Chair, RAPS Editorial Advisory Committee

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Published by RAPS © 2021. Hardcover. Two Volumes. 1,524 pages. ISBN: 978-1-947493-69-8.

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