2 Pharmaceutical Technology
®
Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com
REGULATIONS
6 Master File
Submission of Structures
Barbara Scott, David Green, Marlene Kim, Naomi Kruhlak,
Tyler Peryea, and David Skanchy
12 The Future is the Present:
Artificial Intelligence in
Pharmaceutical Manufacturing
Adam Fisher
16 Convergence in the
Global Regulatory Village
Ashley Boam and Theresa Mullin
QUALITY
20 Knowledge as the Currency of Managing
Risk: A Smart Investment for Patients
Martin J. Lipa and Anne Greene
30 ICH Q9: Aligning ROI, Quality
Risk Management, QRM, and
Pharmaceutical Innovation
Rick L. Friedman, David Lebo, Lawrence Liberti, and GK Raju
46 Quality Quartets in Risk-Based
Qualification: ICH Q9(R1) Considerations
Kevin O'Donnell and Cliff Campbell
FROM THE EDITOR
4 Moderating Innovation to Equipoise Risk
Chris Spivey
51 Ad Index
Cover image: Vitalii Vodolazsky - stock.adobe.com;
Cover design Maria Xelo
Regulating Innovation,
Quality, and Risk 2024
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F O U N D E R
Mike Hennessy Sr
1 9 6 0 - 2 0 2 1
EDITORIAL
Editorial Director Chris Spivey CSpivey@mjhlifesciences.com
Senior Editor Felicity Thomas FThomas@mjhlifesciences.com
Managing Editor Susan Haigney SHaigney@mjhlifesciences.com
Science Editor Feliza Mirasol FMirasol@mjhlifesciences.com
Assistant Editor Daria Husni DHusni@mjhlifesciences.com
Creative Director, Publishing Melissa Feinen
Senior Art Director Marie Maresco; Senior Graphic Designer Maria Xelo
CONTRIBUTING EDITORS:
Hallie Forcinio, editorhal@cs.com; Susan J. Schniepp, sue.schniepp@mac.com;
Cynthia A. Challener, PhD challener@vtlink.net
CUSTOM CONTENT:
Vice President, Content and Special Projects Colleen Hall;
Director Robert Alaburda; Managing Editor Jeanne Linke Northrop;
Senior Editor Megan Manzano; Senior Editor Shannon Stolz
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MJH LIFE SCIENCES
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