Search results with tag "Signal management"
GVP Module IX: Signal Management
www.ema.europa.eu5 GVP Module IX: Signal Management Signal Management (SM) is a set of activities to determine based on various data sources* whether there are new/changed risks associated with active substances/medicinal products: SM steps: – Signal detection, – Signal validation (and confirmation), – Prioritisation, analysis and assessment,
Q&A on signal management - European Medicines Agency
www.ema.europa.euEMA/261758/2013 Page 5/10 States where the medicinal product is authorised . The standalone signal notification form and the national contact points are available on the . EMA signal management webpage . All other validated signals (e.g. detected from sources other than E udraVigilance or falling out side the
Guideline on good pharmacovigilance practices (GVP)
www.ema.europa.eu• provide general guidance and requirements on scientific and quality aspects of signal management (IX.B.); • describe roles, responsibilities and procedura l aspects in the setting of the EU signal management