Regulatory Affairs Professionals Society v
Editors
Linda McBride, RPh, RAC-US
Partner
IAA Consulting LLC
Siegfried Schmitt, PhD
Vice President Technical
Parexel
Authors
Kholoud M. Abdelfattah, MSc, CSRT-
HMS
Regulator-Clinical Assessor
Egyptian Drug Authority
Sharry Arora, MPharm, MTOPRA,
RAC-Drugs
Regulatory Affairs Consultant
Simon Authier, DVM, PhD, MBA,
MSc, DSP
Charlene F. Barroga, PhD, DABT
VP/Head, Non-Clinical Drug Safety
Enveda Therapeutics Inc.
Brix Gil Bayuga, RPh
Director, Global Regulatory Affairs CMC
and Devices
Eli Lilly and Company
Nicole Beard, PhD, MSc
Founder and Head of Regulatory Affairs
Biogecho Consulting Sarl
Jennifer G. Brown, PhD, RAC-US
Senior Director, Toxicology
MacroGenics, Inc.
Timothy A. Candy, PharmD, MS, BCPS
Principal Consultant, Regulatory Affairs
Opus Regulatory, LLC
Monique J. Carter, MS, FRAPS
Senior Director, Global Regulatory
Strategy
Pfizer Inc.
Ricki A. Chase, MS
President
RChase Consulting, LLC
Rowena Cook, MS, RAC-Global,
RCC-IVDR
Sr. Regulatory Affairs Specialist
Twist Bioscience
Angela W. Corona, PhD
Senior Scientific Director
Omnicom Health Medical
Communications
Cristina Damatarca, MD, PGD
President
SafePharm LLC
Dhanraj Deshmukh, PhD, DABT
Senior Advisor -Toxicology
Eli Lilly and Company
Pragnesh Donga, MPharm, MBA,
RAC-Drugs
Founder and CEO
ArKri Therapeutics
Jennifer Duru, PharmD
Regional Regulatory Stratist
Pfizer Inc.
Sue Duvall, MPA, RN, BS
Principal
Duvall Limited LLC
Robert Falcone, PhD, FTOPRA,
FRAPS
Global Regulatory Manager
IDT – Danaher
Margaret L. Fleming, PhD
Senior Environmental Scientist
Personal Care Products Council
Cansın Gevrek, BS
Senior Regulatory Affairs Professional
Novo Nordisk A/S
Kathleen Grim, MS
Principal Consultant
Opus Regulatory, LLC
Alan M. Hoberman, PhD, DABT,
ATSF
Senior Advisor
Charles River Laboratories
Karl-Heinz Huemer, MD, PhD
Founder
khh consult gmbh
Hannah Jin, BSc
Associate Director, CMC Regulatory
Affairs -Devices &Digital Therapeutics
AstraZeneca
Nidhi Kotecha, PhD, MPharm,
RAC-Drugs
Regulatory Affairs Program Director
Gates Institute, University of Colorado,
Anschutz Medical Campus
Rebecca Lalani, PharmD
Principal Consultant
Opus Regulatory, LLC
Author
Acknowledgments