Global Pediatric Development of Drugs, Biologics, and Medical Devices
Table of Contents
Section I: General
Chapter 1 Global Regulatory Initiatives
Section II: North America
Chapter 2 Regulations, Pediatric Study Plan, and Product Development—US
Chapter 3 Rare Diseases—US
Chapter 4 Medical Device Development—US
Chapter 5 Drug Regulations—Canada
Section III: LATAM
Chapter 6 Regulatory Initiatives—Latin America and the Caribbean
Section IV: European Union and Europe
Chapter 7 Paediatric Regulation and the Paediatric Investigation Plan—EU
Chapter 8 Regulatory Requirements—UK
Chapter 9 Regulatory Requirements—Switzerland
Section V: Asia Pacific
Chapter 10 Drug Development—Japan
Chapter 11 Regulations—Australia and New Zealand
Chapter 12 Regulations—China
Chapter 13 Drug Development—India
Section VI: Rest of the World
Chapter 14 Drug and Device Requirements—Rest of the World (RoW)
Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, and Linda McBride, RPh, RAC, editors
About the Book
Available formats: print and e-book
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 will benefit from 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.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2021. Paperback. 186 pages. ISBN (print): 978-1-947493-73-5. ISBN (digital): 978-1-947493-74-2.
