1. Informational Presentation: WHO Biological Standards Summary of January 29-30, 2007 WHO Meeting with WHO Collaborating Centres for Biological Standards and Standardization Paul A. Mied, Ph.D. Blood Products Advisory Committee, 90 th Meeting August 16, 2007

2. CBER WHO Collaborating Centres for Biological Standards and Standardization l National Institute for Biological Standards and Control (NIBSC) l Paul-Ehrlich-Institut (PEI) l Center for Biologics Evaluation and Research (CBER)

3. CBER Meeting Convened by: The Quality Assurance and Safety: Blood Products and Related Biologicals (QSD) team, Department of Medicines Policy and Standards (PSM), World Health Organization (WHO)

4. CBER Objective of the Meeting To strengthen the development of WHO International Biological Reference Preparations for the control of in vitro diagnostic tests related to blood safety.

5. CBER Intended Use of the WHO Biological Reference Preparations Validation, quality control, assessment of comparability, and regulation on a global basis of blood safety-related in vitro diagnostic tests, contributing to a harmonized regulation of blood and blood products.

6. CBER Priority Projects Identified A. Replacement of Existing WHO Biological Reference Preparations Near Exhaustion: 1. Anti-HBs immunoglobulin (proposed 2 nd International Reference Preparation) 2. HCV RNA (proposed 3 rd International Standard) 3. Parvovirus B19 DNA (proposed 2 nd International Standard) 4. Anti-Syphilitic Standard (proposed 2 nd International Standard)

7. CBER Priority Projects Identified (Cont.) B. New WHO Biological Reference Preparations Needed: 5. HIV-1 Genotype Panel (proposed 2 nd International Reference Panel) 6. HIV-2 RNA International Standard 7. Anti-HIV Panel (proposed 2 nd International Reference Panel) 8. HBsAg and HBV DNA Genotype Panels

8. CBER Priority Projects Identified (Cont.) B. New WHO Biological Reference Preparations Needed: 9. Anti-HBc International Standard 10. Anti-HCV Panel 11. Anti-HTLV-I/II Panel 12. Anti-Plasmodium species Panel 13. Anti-Trypanosoma cruzi Preparation / Panel

9. CBER Priority Projects Identified (Cont.) C. Proposed WHO Biological Reference Preparations for Further Discussion: 14. HIV-2 RNA Genotype Panel 15. HCV Genotype Panel 16. Parvovirus B19 Genotype Panel 17. Anti-CMV Standard 18. WNV RNA Preparation / Pan Panel for arthropod-borne flaviviruses RNA

10. CBER Priority Projects Identified (Cont.) C. Proposed WHO Biological Reference Preparations for Further Discussion: 19. HCV Core Antigen Preparation 20. Anti-HHV-8 and HHV-8 DNA Preparations 21. TSE Blood Preparations 22. Blood-borne Bacteria Panel 23. Anti-Leishmania Panel

11. CBER Additional Agreements Among WHO Collaborating Centres l Need for exchange of epidemiological information l Established and new Biological Reference Preparations will be suitable for new technologies l Need for improved collaboration: meetings and telecons l Need to establish a network of all WHO Regions

12. CBER Plan of Action The Priority Projects to establish WHO Biological Reference Preparations to support international regulations for blood and blood products safety will form a five- year In Vitro Diagnostic strategic plan. This plan will be submitted to the ECBS for endorsement in October, 2007.