vii
Author
Acknowledgments
Editors
Linda McBride, RPh, RAC-US
Partner
IAA Consulting LLC
Siegfried Schmitt, PhD
Vice President Technical
Parexel International
Section Editors
Kimberly Belsky, MS, FRAPS
Executive Director, Regulatory Policy and
Intelligence, AdPromo, and Regulatory
Operations
Mallinckrodt Pharmaceuticals
Devanshi Maharaja, MSc, MTech
Manager, Regulatory Affairs
The Janssen Pharmaceutical Companies of
Johnson &Johnson
Daniel G. Mannix, PhD, FRAPS
Senior Vice President, Regulatory Affairs
IO Biotech
Flora Siami, MPH
Senior Vice President
NESTcc
Kip Vought
Partner
IAA Consulting LLC
Authors
Kholoud Mamdouh Abdelfattah, MSc
Clinical Variations Unit Manager
Egyptian Drug Authority
Bayan A. Arar, BPharm, RPh
Healthcare &Life Sciences Consultant
Sharry Arora, MPharm, RAC-Drugs
Regulatory Affairs and Pharmacovigilance
Manager
Xeolas Pharmaceuticals Limited
Simon Authier, DVM, PhD, MSc, MBA
Principal Director
Charles River Laboratories
Ajay Babu Pazhayattil, DBA, MPharm
Partner
Itaan Pharma Inc.
Charlene F. Barroga, PhD, DABT
President &CEO
Tessellux LLC
Nicole Beard, PhD, MSc
Founder, Head International Regulatory
Affairs
Biogecho Consulting Sarl
Prashant Bhatia, MS
Associate Director, Medical Devices and
Combination Products
AstraZeneca Pharmaceuticals
Jennifer G. Brown, PhD, RAC-US
Director, Toxicology
MacroGenics
Timothy A. Candy, PharmD, MS, BCPS
Principal Consultant, Regulatory Affairs
Opus Regulatory, Inc.
Monique J. Carter, MS, RAC-US, FRAPS
Senior Director, Global Regulatory Sciences
-Internal Medicine
Pfizer, Inc.
Mantej (Nimi) Chhina, PhD, JD, MSc
Executive Director, Head of Global R&D
and Regulatory Policy
BioMarin Pharmaceutical Inc.
Rowena Cook, MS, RAC-Global
Senior Regulatory Affairs Specialist
Twist Bioscience
Shuli Cui, MS, RAC-US
Senior Manager, Regulatory Affairs
Alnylam Pharmaceuticals, Inc.
Cristina Damatarca, MD, PgDip
President and Founder
SafePharm LLC
Pragnesh Donga, MPharm, MBA,
RAC-Drugs
Zydus Lifesciences Limited
Robert Falcone, PhD, FRAPS
Senior Regulatory Affairs Manager
Prestige Consumer Healthcare
Stefanie Fasshauer, MBA
Head of Regulatory Affairs, APAC
PharmaLex
Margaret L. Fleming, PhD, MSE
Senior Associate
Exponent
Anu Gaur, PhD, MBA, MSRA, RAC-
Global, RAC-US
President
SYNERGY Global Regulatory Affairs
Consultancy, Inc.