Postapproval Changes for Drugs: A Practical Guide
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Author Acknowledgments
RAPS and the lead editors, Linda McBride and Pallavi Trivedi, thank the following subject matter
experts for sharing their experience and knowledge and volunteering their time to contribute to this first
edition of Postapproval Changes for Drugs: A Practical Guide.
Judy Bingham, MHA
Director
Easington Pty Ltd
Australia
Chapters 4 and 8
Juliane Carvalho, MS, RAC-Drugs
Lead Regulatory Health Project Manager
US Food and Drug Administration
US
Chapter 15
Hakima Hoseh, RAC-Drugs
Regulatory Affairs Senior Manager
Hikma Pharmaceuticals
Jordan
Chapter 5
David Jefferys, MD
Senior Vice President
Eisai
US
Preface
Dachelle Johnson, PharmD, RAC-US
AstraZeneca
Global Development Scientist Director
US
Chapter 20
Yingying Liu, MSc
Associate Director
CSL Behring
Switzerland
Chapter 12 and 17
Murphy Mao, MSc
Senior Regulatory Affair Manager
CSL Behring
China
Chapter 17
Linda McBride, RPh, RAC-US
Regulatory and Compliance Consultant
US
Preface, Chapters 9, and 11
Karin McIntosh, MPharm, RAC-Drugs
Vice President, Head of Regulatory Affairs
NexImmune Inc.
US
Chapters 7 and 16
Melodi McNeil, RPh, MS
Director, Regulatory Policy and Intelligence
AbbVie
US
Chapter 1
Moonmoon Mishra, MPharm
Senior Manager, Regulatory Affairs
Viatris Inc. (Erstwhile Mylan Pharmaceuticals Inc.)
India
Chapters 6 and 7