Global Pediatric Development of Drugs, Biologics, and Medical Devices

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)

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.