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.

View Now

ISPE Drug Shortages Initiative Core Team

Diane L. Hustead
Director, Regulatory Affairs
Merck & Co., Inc.
James Canterbury
Principal, Consulting
Ernst & Young LLP
Placeholder Person Graphic
Dawn Culp
VP Regulatory Affairs
Nasir Egal
Vice President, Global Quality
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
Placeholder Person Graphic
Karen Hirshfield, RPh
Director, Enterprise Regulatory Compliance
Johnson & Johnson
Placeholder Person Graphic
Drishya Nair
LifeSciences Advisory Consultant
Ernst & Young
Terrance Ocheltree, PhD, RPh
Head Regulatory and Quality Assurance
Corium International Mfg Group
Placeholder Person Graphic
Mukul Shukla
Managing Director
Placeholder Person Graphic
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, Ph.D.
CMC Pharmaceutical Consultant
Placeholder Person Graphic
Carol M. Winfield
Senior Director, Regulatory Operations
Thomas Zimmer, PhD
VP, European Operations

For more information, contact RegulatoryAffairs@ISPE.org.