iv
Author Acknowledgments
RAPS and the lead editor, Peter Takes, recognize the work of the following subject matter experts for contributing to
this compendium, Quality Management Systems for Drugs and Devices.
Chapter 1
Abhishek Harde, PMP, RAC
Regulatory Solutions Manager
US
Chapter 2
Gert Bos, MSc, PhD, FRAPS
Chief Scientific Officer, Executive
Director, and Partner
Qserve Group
Netherlands
Chapter 3
Karen Fan, MSc, RAC, Peng
EU MDR Consultant
Johnson &Johnson Surgical
Vision, Inc.
Canada
Charles Tam, MBA
Senior Manager, Regulatory
Affairs, Intelligence, and
Governance
Edwards Lifesciences (Canada) Inc.
Canada
Danuta Zylka, RAC
Senior Manager, Regulatory
Affairs, Global
Insulet Corporation
Canada
Chapter 4
Siegfried Schmitt, PhD
Vice President, Technical
Parexel
UK
Chapter 5
Robert V. Packard
President
Medical Device Academy, Inc.
US
Leo Lagrotte
Senior Regulatory Consultant
US
Chapter 6
Peter Schiemann, PhD
Managing Partner
Widler &Schiemann AG
Switzerland
Beat E. Widler, PhD
Managing Partner
Widler &Schiemann AG
Switzerland
Chapter 7
Ajay Babu Pazhayattil
Principal
cGMP World
Canada
Naheed Sayeed-Desta
Deputy Director
Sanofi
Canada
Queenia Lee
Senior Manager, Global Regulatory
Intelligence and Policy
Apotex
Canada
Chapter 8
Navneet Sekhon
President
AxSource Consulting Inc.
Canada
Chapter 9
Dorota Grabowska, PhD
Senior Scientist
Department of Radiology
Washington University School of
Medicine, St. Louis
US
Peter A. Takes, Ph.D. RAC,
FRAPS
Director, Science Management and
Leadership (MS) Program
Webster University
Principal, Regulatory Intelligence
Associates, LLC
US