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


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
Director, Regulatory Affairs
Merck & Co., Inc.
Chair
James Canterbury
Principal, Consulting
Ernst & Young LLP
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Dawn Culp
VP Regulatory Affairs
Hikma
Nasir Egal
Vice President, Global Quality
Sanofi
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
Partner
PricewaterhouseCoopers LLP

ISPE:

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
ISPE
Thomas Zimmer, PhD
VP, European Operations
ISPE

For more information, contact RegulatoryAffairs@ISPE.org.