Medicine Safety in a World of Science Without Borders

Saturday, February 19, 2011: 8:00 AM-9:30 AM
147B (Washington Convention Center )
Worldwide development, manufacturing, and availability of medicines provide improved health care and cost savings. With it comes a more complex challenge of guaranteeing the safety of the supply, with recent cases of ethylene glycol (antifreeze) in liquid formulations and melanin in baby formula. In 2008, contaminations in imported heparin caused serious injuries and deaths in the United States. The ensuing investigations brought together the combined expertise of pharmaceutical sciences, chemistry and biology disciplines, the U.S. Food and Drug Administration, quality control, manufacturing, and others. Lessons learned have since been implemented to improve security of the supply chain for this and other agents. The heparin story and implications for an increasingly integrated world of medicine will be discussed.
William T. Beck, University of Illinois
Guill Wientjes, Ohio State University
Zachary Shriver, Massachusetts Institute of Technology
Structural and Biological Aspects of Heparin Impurities and Contaminants
Robert Linhardt, Rensselaer Polytechnic Institute
Heparin and Other Polydisperse Drugs: How To Monitor Their Safety
Ali Al-Hakim, U.S. Food and Drug Administration
Impact of Heparin Crisis on Public Standards and Regulatory Process
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