The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus


EMA/CHMP/BWP/723009/2014 Committee for Medicinal Products for Human Use (CHMP)

Document Type:
Refelction Paper
• 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?

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information