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Module Ix Signal Management
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Q&A on signal management - European Medicines Agency
www.ema.europa.euModule IX – Signal management of the guideline on good pharmacovigilance practices (GVP) . The guidance published as GVP is the principal guidance supporting im plementation of and compliance with legal requirements. Concerning the pilot on signal detection in EudraVigilance, MAHs should monitor EMA targeted
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.euGuideline on good pharmacovigilance practices (GVP) - Module IX Addendum I EMA/209012/2015 Page 3/10 IX. Add I.1. Introduction Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI ) is an established method of signal detection.