SOCIAL QUESTIONS|health|pharmaceutical industry
- tuarascáil sábháilteachta maidir le cás aonair Tagairt Téarmeolaithe COM-GA
- ga
- tuairisc shábháilteachta do chás ar leith Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- ICSR | ICSRs | individual case safety report
- en
- Sainmhíniú report of information describing adverse events or reactions experienced by an individual patient, in which the events or reactions can be related to the administration of one or more medicinal products at a particular point in time Tagairt "COM-EN, based on: European Medicines Agency. ICH guideline E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - implementation guide - data elements and message specification. 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002767.pdf [28.3.2012]"
- Nóta "The ICSR can also be used for exchange of other information, such as medication errors that do not involve adverse events or reactions. See also:adverse event [ IATE:1863780 ] adverse reaction [ IATE:1146946 ]"
- rapport individuel d'effets indésirables | observation individuelle d'effets indésirables | ICSR
- fr
- Sainmhíniú rapport d'information décrivant les effets indésirables subis par un patient Tagairt COM-FR