viii
The Regulatory Affairs Professionals Society thanks
those individuals who have shared their experience
and expertise with their colleagues by contributing to
this book.
Editors
Monica Meacham, PhD
Associate Director, Regulatory Affairs
ImmunityBio
William K. Sietsema, PhD
Vice President, Global Regulatory Affairs
Caladrius Biosciences
Authors
Anastassios D. Retzios, PhD
President
Bay Clinical R&D Services, LLC
Catherine Lofton-Day
Formerly at Amgen, Inc.
Chris Walker, MSc
Vice President, European R&D, Head of Regulatory
Affairs &UK Sites Head
Amgen, Ltd.
Darin S. Oppenheimer, DRSc
Executive Director Global Regulatory Affairs &Clinical
Safety Devices and Digital Health
Merck &Company
Dave Kern, MBA, RAC
Principal and Founder
K2 Regulatory Consulting
Eric Brass, MD, PhD
Professor Emeritus of Medicine
David Geffen School of Medicine at UCLA
George A. Cusatis, RAC
Associate Director Global Regulatory Affairs &Clinical
Safety Devices and Digital Health
Merck &Company
Jessica L Hale PharmD
Senior Specialist Global Regulatory Affairs &Clinical
Safety Devices and Digital Health
Merck &Company
Jocelyn Jennings, MS, RAC
Senior Director, Regulatory Affairs
John C. Kapeghian, PhD, DAB
President
Preclinical Safety Associates, LL
Kathryn Wekselman PhD
Vice President of Regulatory
MaxCyte, Inc.
Klaus Rose, MD, MS
CEO
klausrose Consulting, Pediatric Drug Development
&More
Margaret A. Hamburg, MD
Former FDA Commissioner
Michael Craig
Principal Consultant (CMC)
Parexel Consulting
Michael J. Vivion, PhD
Principal
ECG Healthcare
Mya Thomae
Regulatory Advisor
Naseem F. Kabir
Director, Global Labeling
Amgen Ltd.
Neal E. Storm, DRSc, MBA, RAC
Director, Global Regulatory Affairs
Amgen Inc.
Pallavi Trevedi, MPH, RAC
Senior Associate
Jeff Yuen and Associates, Inc.
Sharry Arora
Manager
Stephen Antonelli, PhD
Director, Regulatory CMC
Alkermes, Inc.
Suraj Ramachandran, RAC
Director Global Regulatory Affairs &Clinical Safety
Devices and Digital Health
Merck &Company
Susan Capps
Executive Director, Global Value Access &Policy
Amgen Ltd.
Timothy Pang
Senior Director, Informa Pharma Consulting
Informa Intelligence
Tina Soulis, PhD
CEO
Neuroscience Trials Australia
Xinzhao Grace Jiang
Director
Amgen, Inc.
Acknowledgments