Adventitious agents, new technology, and risk assessment, 19-20 May 2011, Baltimore, MD |
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Authors: | Sheets Rebecca Loewer Johannes Raychaudhuri Gopa Petricciani John |
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Institution: | National Institutes of Health, National Institute of Allergy & Infectious Diseases, Bethesda, MD, USA. RSheets@niaid.nih.gov |
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Abstract: | In May 2011, the International Alliance for Biological Standardization, with the cooperation of WHO, FDA, and NIAID, organized a conference on adventitious agents that might be found in biological products using new technology (http://www.iabs.org/index.php/past-conference-reports/116-baltimore-2011-slides). The implications of such findings on risk assessment also were considered. Topics that were addressed included: a) current routine testing – what are we doing now?; b) recent advances in testing – what tests are being explored/applied?; c) examples of finding agents with “new” techniques; and d) risk assessment, including recent WHO activities. A draft algorithm for risk assessment was discussed in terms of its applicability to a variety of potential new agents and the possibilities for improving it. |
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