Global Pediatric Development of Drugs, Biologics, and Medical Devices
xi
Author Acknowledgments
RAPS and the lead editors, Jocelyn Jennings and Linda McBride, thank the following subject matter
experts for sharing their experience and knowledge and volunteering their time to contribute to this first
edition of Global Pediatric Development for Drugs, Biologics, and Medical Devices. They also would like to
recognize Lynne Georgopoulos, RN, MSHS, RAC, and Azzurra Ravizza, MSc, whose work on the chap-
ter on global pediatric drug development in the fifth edition of Fundamentals of International Regulatory
Affairs (2021) contributed significantly to the content of this book.
Ashley Butler, MHA
Senior Manager, Regulatory Operations
Sigilon Therapeutics
US
Chapter 13
Monique Carter, MS, RAC
Senior Director, Global Regulatory Affairs
Pfizer
US
Chapter 10
Sandra Gonzalez, PharmD, MBA, RAC
Director, International Regulatory Affairs
Horizon Therapeutics
US
Chapter 6
Ruchi Gupta, MS
Regulatory Program Director
US
Chapters 8 and 9
Karl-Heinz Huemer, PhD, MD
AGES /BASG Clinical Assessor
Austrian Agency for Health and Food Safety
Austria
Chapter 7
Jocelyn Jennings, MS, RAC (US, Drugs,
Devices)
Vice President, Regulatory Affairs
Mycovia Pharmaceuticals, Inc.
US
Chapter 2
Allison Komiyama, PhD, RAC
Principal Consultant
Acknowledge Regulatory Strategies, LLC
US
Chapter 4
Yingying Liu, MSc
Associate Director
CSL Behring
Switzerland
Chapter 12
Shikha Malik, MPharm, MS, RAC
Regulatory Affairs Specialist II
Abbott
US
Chapter 4
Linda McBride, RPh, RAC
Regulatory and Compliance Consultant
US
Chapter 1
xi
Author Acknowledgments
RAPS and the lead editors, Jocelyn Jennings and Linda McBride, thank the following subject matter
experts for sharing their experience and knowledge and volunteering their time to contribute to this first
edition of Global Pediatric Development for Drugs, Biologics, and Medical Devices. They also would like to
recognize Lynne Georgopoulos, RN, MSHS, RAC, and Azzurra Ravizza, MSc, whose work on the chap-
ter on global pediatric drug development in the fifth edition of Fundamentals of International Regulatory
Affairs (2021) contributed significantly to the content of this book.
Ashley Butler, MHA
Senior Manager, Regulatory Operations
Sigilon Therapeutics
US
Chapter 13
Monique Carter, MS, RAC
Senior Director, Global Regulatory Affairs
Pfizer
US
Chapter 10
Sandra Gonzalez, PharmD, MBA, RAC
Director, International Regulatory Affairs
Horizon Therapeutics
US
Chapter 6
Ruchi Gupta, MS
Regulatory Program Director
US
Chapters 8 and 9
Karl-Heinz Huemer, PhD, MD
AGES /BASG Clinical Assessor
Austrian Agency for Health and Food Safety
Austria
Chapter 7
Jocelyn Jennings, MS, RAC (US, Drugs,
Devices)
Vice President, Regulatory Affairs
Mycovia Pharmaceuticals, Inc.
US
Chapter 2
Allison Komiyama, PhD, RAC
Principal Consultant
Acknowledge Regulatory Strategies, LLC
US
Chapter 4
Yingying Liu, MSc
Associate Director
CSL Behring
Switzerland
Chapter 12
Shikha Malik, MPharm, MS, RAC
Regulatory Affairs Specialist II
Abbott
US
Chapter 4
Linda McBride, RPh, RAC
Regulatory and Compliance Consultant
US
Chapter 1