Risk modeling for plasma-derived medicinal products
European legislation (EMA guidelines) requires viral risk assessments of all plasma products. TTA has developed a probabilistic risk assessment model specifically for this purpose and analyzed the risk of transmission of various infectious diseases for most plasma derived products. In addition, manufacturers of plasma products must annually report to EMA on frequencies of HIV, HBV and HCV infections among donors in order to control the risk of transmission. A monitoring tool and statistical tests were developed to check changes in the number of infections in the donor population at national and regional levels. The developed tests are generic and can be applied by any blood establishment or plasma fractionation institute. TTA also provides advice on further implementation of control strategies to Sanquin Plasma Products Division, IPFA and EMA.
- Janssen MP, Cator EA, van der Poel CL, Schaasberg WP, Bonsel GJ, van Hout BA. Monitoring viral incidence rates: tools for the implementation of European Union regulations. Vox Sang 2009; 96(4):298-308.
- Janssen MP, Over J, van der Poel CL, Cuijpers HTM, van Hout BA. A probabilistic model for analyzing viral risks of plasma-derived medicinal products. Transfusion 2008; 48(1):153-62.