Drug Shortages Initiative

ISPE’s Drug Shortages Initiative focuses on the technical, scientific, manufacturing, quality and compliance issues associated with a company’s supply chain and related to its ability to source, manufacture and distribute products that have resulted in drug shortages.

Any effort to effectively address the complex and multi-faceted issues contributing to drug shortages requires close technical collaboration and clear communication between the pharmaceutical industry and global health authorities. For nearly a decade, ISPE has been instrumental in facilitating communication between the different sectors of the pharmaceutical industry and global health authorities related to drug shortages.

Drug Shortage Publications

ISPE Drug Shortages Initiative Core Team

Diane L. Hustead
Director, Regulatory Affairs
Merck & Co., Inc.
James Canterbury
Principal, Consulting
Ernst & Young LLP
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Dawn Culp
VP Regulatory Affairs
Nasir Egal
Vice President, Global Quality
Joseph C. Famulare
Vice President, Global Quality Compliance and External Relations
Genentech, A Member of the Roche Group
Melissa Figgins
Executive Director
Quality Executive Partners
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Erin Fox, Pharm D
Senior Director, Drug Information & Support Services
University of Utah Health
Donna Gulbinski
Chief Quality & Reg Affairs Officer
Civica, Inc.
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Emma Harrington
Executive Director Quality
Sandoz Inc., Broomfield Manufact.
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Karen Hirshfield, RPh
Director, Enterprise Regulatory Compliance
Johnson & Johnson
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Drishya Nair
LifeSciences Advisory Consultant
Ernst & Young
Terrance Ocheltree, PhD, RPh
Head Regulatory and Quality Assurance
Corium International Mfg Group
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Deborah Tolomeo, PhD, JD
Global Compliance
Genentech Inc
Sumanth Venugopal
PricewaterhouseCoopers LLP


Jean-Francois Duliere
Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
Christopher John Potter, Ph.D.
CMC Pharmaceutical Consultant
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Carol M. Winfield
Senior Director, Regulatory Operations
Thomas Zimmer, PhD
VP, European Operations

For more information, contact RegulatoryAffairs@ISPE.org.