Risk modeling for plasma-derived medicinal products

European legislation (EMEA guidelines) requires viral risk assessments of all plasma products, and TTA developed probabilistic risk assessment methods for this. Manufacturers of plasma products must also report to EMA on frequencies of HIV, HBV and HCV in donor populations. A monitoring tool and statistical tests were developed to check changes in the donor populations at national and regional levels. The developed tests are generic and can be applied by any blood establishment or plasma fractionation institute. TTA provided advice for further implementation at Sanquin Plasma Products, IPFA and EMEA.