signal management process
- Guideline or reference source
- HMAGVP Guideline on good pharmacovigilance practices
- Definition
- Includes the following activities: signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment and recommendation for action [IR 520/2012 Art 21(1)]. It therefore is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, literature information or other data sources, there are new risks causally associated with an active substance or a medicinal product or whether known risks have changed.
- Related Term
- signal validation
Send comments to info@qdossier.com Please read disclaimer before using Qsauri.