Essentials of Healthcare Product Labeling
vii
Author Acknowledgments
RAPS thanks the following subject matter experts for sharing their experience and knowledge and volun-
teering their time to contribute to this second edition of Essentials of Healthcare Product Labeling.
Editor
Cathleen A. O’Connell, PhD, MS, RPh
Authors
Nicole Beard, PhD, MSc
Founder and Head of Regulatory Affairs
Biogecho Consulting GmbH
Luke B. Catanzaro
Associate Director
Janssen Research &Development, LLC
Eleonora Chakraborty, RAC-US, RAC-EU
Associate Director, Regulatory Affairs
Hoi Lam Chan, MPH, BPharm (Hons)
Global Labeling Lead
Pfizer
Rita P. Francis, PhD, MS, MBA
Joy L. Frestedt, PhD, RAC-US, FRAPS
President and CEO
Frestedt Incorporated
Shirley Furesz, PhD, RAC-CAN
Director, Regulatory Affairs, Medical Devices
Innomar Strategies Inc.
Debra B. Goetchius
Associate Director, Global Labeling
Implementation
Janssen Research &Development, LLC
Rosy Henschel Undari
EMEA Regulatory Management Center:
Artwork Management
Janssen-Cilag Limited
Jocelyn Jennings, MS, RAC-US, RAC-Drugs,
RAC-Devices, FRAPS
Vice President, Regulatory Affairs and Quality
Assurance
Mycovia Pharmaceuticals, Inc.
Stephanie Turri Lockman, MS
Associate Director, Global Labeling Center of
Excellence
Janssen Research &Development, LLC
Karen Long, MSc, RAC-US, RAC-EU, RAC-
CAN, RAC-Global
Senior Director, Drug Development
Mesentech, Inc.
Zahra D. Martinez, PharmD, RPh
Associate Director, Global Labeling Product
Leader
Janssen Research &Development, LLC
Mary Speagle, RAC-US, RAC-CAN,
RAC-Drugs
Senior Director, Regulatory Affairs
Innomar Strategies Inc.
Nadja Torres, MD, MPH, MS