2014 Drug Shortage Events

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2014 Events


Industry Roundtable: Keys to Addressing Quality System Issues in Aseptic Manufacturing which May Lead to Shortages


Industry-Regulatory Roundtable: The Roles of Quality Culture and Regulatory Relationships in Preventing Shortages


(1) Plenary Session - w/Audience Q&A

(2) ISPE Drug Shortages Update: ISPE Drug Shortages Prevention Plan

(3) Industry-Regulatory Round Table: Implications of the Findings of the Drug Shortages Task Force

  • John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., United Kingdom
  • Gerald Heddell, Dir, Inspection Enforcement and Standards Division, MHRA, United Kingdom
  • Karen Hirshfield, R.Ph., Senior Compliance Specialist, Genentech-Member of Roche Group, USA
  • Larry Kranking, Executive Director, Commissioning Agents, INC., USA
  • Steven Lynn, Director, Office of Manufacturing and Product Quality, FDA/CDER/OC/OMPQ, USA
  • Francois Sallans, Vice President and Chief Quality Officer, Pharmaceutical, Johnson & Johnson, Belgium
  • Doug Throckmorton, M.D., Deputy Director, Regulatory Programs, FDA/CDER, USA
  • Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA
  • Frances Zipp, President, Lachman Consultant Services Inc, USA


International Launch of the ISPE Drug Shortages Prevention Plan

Presentations by

  • Brendan Cuddy, Scientific Administrator, Manufacturing and Quality Compliance, Compliance & Inspections Department, EMA
  • Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, Drug Shortages Task Force, US FDA/CDER
  • Mark Birse, Group Manager, GMDP, IES, MHRA


  • Learn more about ISPE’s Drug Shortages Initiative by visiting ISPE’s website www.ispe.org/drug-shortages-initiative
  • Volunteer as a subject matter expert on a team working with the ISPE Drug Shortages Task Force. Contact ISPE’s Director of Volunteer Development Michael Phelan (mphelan@ispe.org) for more information.


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