Consulting in „Expedited Reporting“ of serious adverse reactions, SAR (15 days or 7 days reports), especially in „not labelled“ reactions – SUSAR – to be reported to authorities and Ethics Committees according to the European Directive 20/2001/EC, FDA and/or local laws, respectively Electronic Reporting Systems: central reporting of SUSAR to the EMEA; support and consulting in the development / selection / validation of systems