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Global Pediatric Development of Drugs, Biologics, and Medical Devices

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Global Pediatric Development of Drugs, Biologics, and Medical Devices
By Jocelyn Jennings, MS, RAC (US, Drugs, Devices) and Linda McBride, RPh, RAC


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.

Global Pediatric Development of Drugs, Biologics, and Medical Devices describes various regulatory initiatives that have been instrumental in increasing the availability pediatric drug products and pediatric medical devices, including global collaboration and harmonization initiatives on the part of regulatory authorities.

Global Pediatric Development of Drugs, Biologics, and Medical Devices aims to facilitate strategic discussions, to foster collaboration on pediatric plan development, and to progress the availability of new therapies to prevent, diagnose, and treat pediatric diseases worldwide.

The authors cover the global pediatric requirements for the major markets, including the US, EU, Switzerland, UK, Canada, Australia, Japan, and China, in addition to India, the Middle East, and Latin America. Regulatory professionals at all levels employed in the industry, academia, and health authorities will benefit from this comprehensive look at pediatric regulations.

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.

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

 
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