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Postapproval Changes for Drugs: A Practical Guide (e-book)

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Postapproval Changes for Drugs: A Practical Guide (e-book)

Table of Contents

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Lead Editors

Linda McBride, RPh, RAC-US and Pallavi Trivedi, MPH, RAC-US

Contributing Authors


Product Description

Postapproval changes are a vital part of medicines development and regulatory affairs and reflect the dynamic and iterative nature of science and how products develop and mature across the lifecycle. RAPS new book, Postapproval Changes for Drugs: A Practical Guide, illustrates the breadth of this complex topic including key aspects of marketing authorization transfers, renewals, and administrative changes; quality and CMC changes; safety and product information-related changes; postauthorization commitments and studies; and postmarketing surveillance and risk management.

Who should buy this book?

Postapproval Changes for Drugs 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 postapproval change 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 and promote collaboration on the necessary updates and changes that occur after initial marketing application approval to support the continued availability of new therapies to diagnose, prevent, treat, and cure diseases worldwide.

Postapproval changes are a vital part of medicines development and regulatory affairs, and RAPS new book covers the breadth of issues which encompass postapproval changes, ranging from marketing authorization transfers, administrative changes, late phase renewals through to additional indications. From a comprehensive global perspective, this book illustrates the differences between the Americas, Europe, Asia, Middle East and North Africa (MENA), and sub-Saharan Africa.
David Jefferys, MD
Senior Vice President, Eisai

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Published by RAPS © 2022. E-book. 288 pages. ISBN: 978-1-947493-81-0.
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