Dr Ana Padilla, Blood Products amp; related BiologicalsEssential :安娜帕迪拉博士,血液制品及相关biologicalsessential;.pptVIP

Dr Ana Padilla, Blood Products amp; related BiologicalsEssential :安娜帕迪拉博士,血液制品及相关biologicalsessential;.ppt

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DrAnaPadilla,BloodProducts

Blood Products related Biologicals: SoGAT, 28 May 09 * | Dr Ana Padilla, Blood Products related Biologicals Essential Medicines and Pharmaceutical Policies Department Health Systems and Services WHO Biological Reference Standards In vitro diagnostic devices - Summary of the 2nd Meeting of the WHO CC - Biological Standardization (*) Constitutional responsibility WHO is mandated by its Member States to …develop, establish and promote international standards for biological products. In practice, biological products cover Vaccines Blood and blood products In vitro biological diagnostic devices Other biological products (*) Expert Committee for Biological Standardization WHO Biological Reference Standards Recommendations for the preparation, characterization and establishment of international and other biological reference standards (revised 2004): Annex 2, WHO TRS, No 932, 2005. Report of the WHO Consultation on Global Measurement Standards and their use in the in vitro biological diagnostic field. WHO Geneva, June 2004: /bloodproducts/ivd/infectious_markers WHO Biological Reference Preparations (/bloodproducts*) Nucleic Acid Technology: HBV/HCV/HIV/Parvovirus/HAV (IS) HIV genotype reference panel Immunoassays: HBsAg; Anti-HBs; Anti-HBc HIV p24 antigen Anti-HIV subtype reference panel vCJD reference materials Blood grouping reagents Platelets immunology Blood Coagulation disorders (*) WHO Catalogue of Biological Reference Preparations WHO IVD Standardization 2nd WHO CC* Meeting: 17-19 February 2009 Follow-up from the WHO CC Meeting in 2007 Coordinate needs/priorities with WHO programs Discuss priority projects: WHO Biological Reference Preparations to optimally support global public health Update the strategic plan established in 2007 Strengthen collaboration (WHO CC-Network model) *WHO CCs for Biological Standards Standardization: CBER/FDA, USA; NIBSC, UK; PEI, Germany Priority Projects – Parasites Next steps Decisions Coordinator Pro

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