Global Pediatric Development of Drugs, Biologics, and Medical Devices
iii
Table of Contents
Foreword. ................................................................................................................................................vii
Preface. .....................................................................................................................................................ix
Author Acknowledgments....................................................................................................................... xi
Section I: General
Chapter 1 Global Regulatory Initiatives.............................................................................................. 1
By Linda McBride, RPh, RAC
Section II: North America
Chapter 2 Regulations, Pediatric Study Plan, and Product Development—US. .................................5
By Jocelyn Jennings, MS, RAC (US, Drugs, Devices)
Chapter 3 Rare Diseases—US........................................................................................................... 33
By Kathrin Schalper, PhD, RAC
Chapter 4 Medical Device Development—US ................................................................................45
By Allison Komiyama, PhD, RAC and Shikha Malik, MPharm, MS, RAC
Chapter 5 Drug Regulations—Canada. ............................................................................................53
By Rishi Mehta, RAC
Section III: LATAM
Chapter 6 Regulatory Initiatives—Latin America and the Caribbean. .............................................59
By Sandra Gonzalez, PharmD, MBA, RAC
Section IV: European Union and Europe
Chapter 7 Paediatric Regulation and the Paediatric Investigation Plan—EU................................... 73
By Karl-Heinz Huemer, PhD, MD
Chapter 8 Regulatory Requirements—UK........................................................................................ 97
By Ruchi Gupta, MS
iii
Table of Contents
Foreword. ................................................................................................................................................vii
Preface. .....................................................................................................................................................ix
Author Acknowledgments....................................................................................................................... xi
Section I: General
Chapter 1 Global Regulatory Initiatives.............................................................................................. 1
By Linda McBride, RPh, RAC
Section II: North America
Chapter 2 Regulations, Pediatric Study Plan, and Product Development—US. .................................5
By Jocelyn Jennings, MS, RAC (US, Drugs, Devices)
Chapter 3 Rare Diseases—US........................................................................................................... 33
By Kathrin Schalper, PhD, RAC
Chapter 4 Medical Device Development—US ................................................................................45
By Allison Komiyama, PhD, RAC and Shikha Malik, MPharm, MS, RAC
Chapter 5 Drug Regulations—Canada. ............................................................................................53
By Rishi Mehta, RAC
Section III: LATAM
Chapter 6 Regulatory Initiatives—Latin America and the Caribbean. .............................................59
By Sandra Gonzalez, PharmD, MBA, RAC
Section IV: European Union and Europe
Chapter 7 Paediatric Regulation and the Paediatric Investigation Plan—EU................................... 73
By Karl-Heinz Huemer, PhD, MD
Chapter 8 Regulatory Requirements—UK........................................................................................ 97
By Ruchi Gupta, MS