Moderators: Dr J. Lower, Germany, and Dr H. Imelik, Estonia

Blood products and related substances raise particular concerns because of the potential safety issues. Two different groups of products can be considered in terms of their preparation and scope of application:

• blood and blood components derived from single donations or small pools, which are used for direct transmission to patients; and

• plasma-derived products obtained from fractionation of plasma pools made from several thousand plasma units (a large number of donations).

Various challenges to assure appropriate evaluation of human blood plasma products include the need to improve the quality and safety of plasma globally, the introduction of viral inactivation/removal procedures in the manufacturing processes, strengthening the technical competence and expertise of national control authorities, and coordination across national boundaries to ensure control. In parallel, biological standardization and control measures need to keep pace with new technologies.