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 Shortages News

Drug Shortage Webinars

Opportunities for Drug Shortage Prevention – Industry and Regulator Views

Opportunities for Drug Shortage Prevention – Industry and Regulator Views

Webinar Presented on 30 September 2021 - It has been and continues to be critical to ensure uninterrupted supply for all essential drug products that address serious medical conditions and support emergency healthcare. This webinar has been developed in response to the increasing interest in how best to ensure continuous pharmaceutical supply. Industry and regulatory experts will reflect on the current state of drug shortage prevention and share thoughts on how we may do better.

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Resolving & Avoiding Drug Shortages & the Health Crises They Create

Resolving & Avoiding Drug Shortages & the Health Crises They Create

Webinar Presented on 1 September 2020 - Drug shortages are not just a supply chain problem. They are a problem for patients. Sometimes these patients are so at risk, resolving the shortage could make the ultimate difference.

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ISPE Drug Shortages Initiative Core Team

Diane L. Hustead
Senior Director, Regulatory Affairs
Merck & Co., Inc.
James Canterbury
Principal, Consulting
Ernst & Young LLP
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Dawn Culp
VP Regulatory Affairs
Nasir Egal
VP, Quality & Regulatory Compliance
Ylva Ek
Chief Quality Officer (CQO)
KeyPlants AB
Melissa Figgins
Executive Director
Quality Executive Partners
Erin Fox, Pharm D
Senior Director, Drug Information & Support Services
University of Utah Health
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Karen Hirshfield, RPh
Director, Enterprise Regulatory Compliance
Johnson & Johnson
Drishya Nair
Manager, Life Sciences Consulting
Ernst & Young US LLP
Terrance Ocheltree, PhD, RPh
Head Regulatory and Quality Assurance
Corium Inc
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Mukul Shukla
Managing Director
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Deborah Tolomeo, PhD, JD
External Collaborations
Genentech Inc
Sumanth Venugopal
PricewaterhouseCoopers LLP


Jean-Francois Duliere
Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
Christopher John Potter, PhD
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.