Global Pediatric Development of Drugs, Biologics, and Medical Devices

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Global Pediatric Development of Drugs, Biologics, and Medical Devices

Table of Contents


Lead Editors

Jocelyn Jennings, MS, RAC (US, Drugs, Devices) and Linda McBride, RPh, RAC

Product Description

Global Pediatric Development of Drugs, Biologics, and Medical Devices takes an in-depth look at creating and implementing a global regulatory strategy for bringing pediatric drug products and pediatric medical devices to the healthcare market. This comprehensive resource will help you gain insight into the pediatric study plan (PSP) and pediatric investigation plan (PIP). Chapters cover pediatric regulations, regulatory requirements, tools, incentives, and pathways for developing products for the pediatric population.

Who should buy this book?

Different aspects of this book serve as great resources for regulatory professionals at all levels of RAPS Regulatory Competency Framework. Information provided in the individual chapters for a specific country/region will serve well those regulatory professionals at Levels 1 and 2 of the framework who are building their foundational knowledge of the laws, regulations, and guidances in their assigned country/region. Further, the global details provided in the book are a great resource for more senior regulatory professionals at Levels 3 and 4 who are responsible for global strategy development.

Developing drugs, biologics, and medical devices for pediatric patients is challenging; however, bringing products to market that fulfill an unmet medical need in this special population is tremendously rewarding.
Linda McBride, RPh, RAC
Regulatory and Compliance Consultant

Published by RAPS © 2021. Paperback. 186 pages. ISBN: 978-1-947493-73-5.

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