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Author Acknowledgments
The Regulatory Affairs Professionals Society would like to express appreciation to the following
subject matter experts who shared their experience and knowledge and volunteered their time by
contributing to this book. RAPS also would like to recognize the work of the first edition authors
who laid the groundwork for this second edition.
Andrea Armando, RAC
Senior Manager, Regulatory Affairs Operations
DiaSorin
Italy
Gert Bos, MSc, PhD, FRAPS
Executive Director and Partner
Qserve Consultancy BV
Netherlands
Stanley F. Chalvire
Member
Morse, Barnes-Brown &Pendleton, PC
US
Xianjun (Catherine) Chen, MS, RAC
Principal Regulatory Specialist
Sports Medicine and ENT
Smith &Nephew
US
Koen Cobbaert, MSEE, MSRM
Chair Software Focus Group
COCIR
Belgium
Sean D. Detweiler
Member/Partner
Morse, Barnes-Brown &Pendleton, PC
US
Scott D. Dickerhoff
Director of Regulatory Affairs-Acoustic
Implants
Cochlear Ltd.
US
David A. Fazzolare
Patent Attorney
Novozymes
US
Anu Gaur, PhD, MBA, MSRA, RAC
Faculty, Regulatory Affairs Graduate Program
College of Professional Studies (CPS)
Northeastern University
US
Jeffrey N. Gibbs
Director
Hyman, Phelps &McNamara, PC
US
Dorota Grabowska, PhD
Senior Scientist
Department of Radiology
Washington University School of Medicine, St.
Louis
US