Advisory Committee
Holiday Inn
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Administrative Remarks |
William Freas, PhD, CBER, Executive Secretary
TSEAC |
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Opening Remarks |
Suzette Priola, PhD, NIAID, NIH, Chairperson TSEAC |
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Informational Presentations
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Update on US and worldwide BSE status |
Lisa Ferguson, DVM, APHIS, USDA |
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Criteria for considering label claims of effective
decontamination for surgical instruments exposed to TSE agents: discussions
of a recent FDA Device Panel |
Sheila Murphey, MD, or other, CDRH |
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Update on vCJD in |
Azra C. Ghani, PhD, |
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Questions for speakers |
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Topic 1: Progress Report on FDA’s Risk Assessment
for Potential Exposure to Variant Creutzfeldt-Jakob Disease in Human Plasma-Derived
Antihemophilic Factor (FVIII) Products |
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Variant CJD risk associated with human plasma
derivatives: Introduction and overview
of risk model |
Steven Anderson, PhD, OBE, CBER |
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Prevalence estimates for vCJD in the |
David Asher, MD, OBRR, CBER |
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Modeling risk of vCJD in US donors – residual risk
and efficiency of donor deferral |
Alan Williams, PhD, OBRR, CBER |
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VCJD infectivity of plasma – estimates from
experimental models |
David Asher, MD, OBRR, CBER |
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Review of TSE clearance in FVIII product
manufacturing |
Dorothy Scott, MD, OBRR, CBER |
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FVIII product usage in clinical settings |
Mark Weinstein, PhD, OBRR, CBER |
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Summary of FDA proposals for FVIII risk assessment
input parameters |
Steven Anderson, PhD, OBE, CBER |
TSEAC Agenda, October 31, 2005, (continued)
Topic 2:
Labeling Claims for Filters Intended to Remove TSE Infectivity from
Blood Components |
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Prospects for reduction or removal of TSE agent
infectivity from blood components by filtration and criteria for allowing
claims: Introduction |
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Performance of Pall Corporation Leukoreduction
filters on TSE infectivity of blood components: experimental studies and
European experience |
Pall Corporation representative |
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Selection and performance of resin-bound ligands
for removal of TSE infectivity from plasma |
Robert Rohwer, PhD, PRDT (with ProMetic and ARC), |
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Other industry/academic filter/chromatography
developer |
Alicon
AG, Schlieren, |
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Open Public
Hearing |
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Committee discussion and recommendations |
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