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Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus
Origin/Publisher:
EMA/CHMP/BWP/723009/2014 Committee for Medicinal Products for Human Use (CHMP)
Document Type:
Refelction Paper
Content:
• Clinical experience with HEV infections and transfusion-associated infections: How serious are HEV infections and which patient populations may be particularly at risk?
• HEV detection and epidemiology of HEV in blood/plasma donations
• Do serum antibodies against HEV significantly neutralise?
• Latest experience from studies on inactivation/removal of HEV: Which steps are effective to remove / inactivate HEV? Which model viruses can be used to assess that? Do we need more virus validation data?
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