ix
Author Acknowledgments
The Regulatory Affairs Professionals Society (RAPS) would like to express appreciation to the follow-
ing subject matter experts who shared their experience and knowledge and volunteered their time by
contributing to this book. RAPS also would like to recognize Meredith Brown-Tuttle whose work on
both the first and second editions laid the groundwork for this third edition.
Daanish Ashraf, PharmD
Regulatory Intelligence Lead
Biogen
US
James Biddlecombe
Senior Consultant
Deloitte LLP
UK
Gert Bos, MSc, PhD, FRAPS
Executive Director and Partner
Qserve Consultancy BV
Netherlands
Linda Bowen, MSc, RAC,
FRAPS
Head of Regulatory Policy and
Intelligence
Seagen
US
George Cusatis MS, RAC
Director
Merck and Co., Inc.
US
Reid D’Amico, PhD
Specialist Senior
Deloitte Advisory
US
João Duarte, MPharm
Director, Chief of Staff
and Head of Regulatory
Intelligence and Policy
Global Regulatory Affairs
Alexion Pharmaceuticals
France
Malka Fraiman, MSC
Specialist Master
Deloitte &Touche LLP
US
Mayura Gill
Manager
Deloitte &Touche LLP
US
Jessica Hale, PharmD
Senior Specialist
Devices and Digital Health
Merck &Co., Inc.
US
David Husman, PhD, ASQ
CPGP, RAC
President and Principal
Consultant
David Husman Consulting
US
Robert Kester, MS
Senior Director, Global
Regulatory Affairs
Oncology and In-Vitro
Diagnostics Group
GRACS
US
Susan Laufer, MSc
Senior Consultant
Parexel International
US
Andrew Leung, PharmD
Regulatory Scientist Assistant
Devices and Digital Health
Merck &Co., Inc.
US