Regulatory Intelligence Reimagined
v Regulatory Affairs Professionals Society
Author Acknowledgments
The Regulatory Affairs Professionals Society (RAPS) would like to express appreciation to the following subject matter experts
who shared their experience and knowledge and volunteered their time by contributing to this book.
EDITOR
Linda Bowen, MS, RAC-CAN,
RAC-EU, RAC-US, FRAPS
Adjunct Professor
Temple University Pharmacy School
AUTHORS
Lieselotte L. Bloss, DVM
Senior Consultant, Regulatory Affairs
Managing Partner
The Bracken Group
Kenneth G. Butz, MS
Director, Regulatory Affairs, Medical
Devices and Diagnostics
PPD clinical research business of
Thermo Fisher Scientific
Tony E. Catka, PhD
Director, Regulatory Intelligence
Ionis Pharmaceuticals, Inc.
James Lindsay Cobbs, RPh
Principal &Senior Policy Advisor
Apath Nexus Consulting
Virginia Cox, JD
Communications Executive
3D Communications
Rachel Cuccias, MS
Chief Executive Officer
FOIA Professional Services, LLC
Soufiane Dib, PharmD
Associate Director, Global Regulatory
Policy &Intelligence
Gilead Sciences
Tom Dillane, MSc
Manager Regulatory Policy &
Intelligence
Alexion AstraZeneca Rare Disease
João Duarte, MSc, MPharm, FRAPS,
FTOPRA
Vice President, Head of Global
Regulatory Affairs Excellence
Ipsen
Pedro Franco, PhD, PharmD, MBA,
MSc
Head of Europe Global Regulatory and
Scientific Policy
Merck Serono Limited UK
Patrick Frey
Senior Director, Regulatory Policy
Neurocrine Biosciences
Rudy Fuentes, PhD, RAC-US
Director Regulatory Affairs
PPD clinical research business of
Thermo Fisher Scientific
Purba Ganguly, MSc, CPhT
Senior Consultant
Sunrise Consulting LLC
Hannah Hapner Hogan, MSc
Manager, Regulatory Affairs
Cencora, Global Consulting Services US
Emily Huddle, BSc
Associate Director
Gilead Sciences
John Joines, RPh
Senior Manager Regulatory Affairs
PPD clinical research business of
Thermo Fisher Scientific
Sam Kay, MPharm
VP, Pharma
Basil Systems
Stephanie Sabatino Kelly, JD, MS
Global Head Regulatory Intelligence
and Policy
Kyowa Kirin, Inc.
Anusha Kesireddy, PhD, MS, BPharm
Manager, Regulatory Affairs
Cencora, Global Consulting Services US
Robert F. Kester, MS
Associate Vice President Global
Regulatory Affairs
Merck &Co., Inc.
Elayne Kimmett, MBA, CQA,
RAC-Global
Global GxP Policy and Regulatory
Intelligence
Vertex Pharmaceuticals
Jeff MacDonald, PharmD, RPh
Associate Director, Global Regulatory
Policy and Intelligence
BeOne Medicines
Kieran Maher, MSc
Associate Director, Regulatory Policy &
Intelligence
Alexion AstraZeneca Rare Disease