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10:13 Sep 20, 2016 |
Dutch to English translations [PRO] Social Sciences - Government / Politics / Government agency policy report | |||||||
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| Selected response from: Erzsébet Czopyk Hungary Local time: 21:21 | ||||||
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Summary of answers provided | ||||
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4 | Signal management group |
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Discussion entries: 1 | |
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Signal management group Explanation: The purpose of this SOP is to ensure that these activities, from signal detection to provision of support to the Pharmacovigilance Risk Assessment Committee (PRAC) in its initial analysis and prioritisation of signals, are handled in an efficient and consistent way and by doing so support pharmacovigilance and risk management at EU level. Module IX - European Medicines Agency - Europa.eu www.ema.europa.eu/docs/en_GB/document.../WC500129138.pdf Signal analysis, prioritisation and assessment by the .... increasingly based on periodic monitoring of large databases such as the ... management or responsibility as specified in Module VI, for potential reports of suspected ADRs, which ... detection may be found in the Report of CIOMS Working group. If this activity is similar to this pharmacovigilance practice and called Signal management, why not Signal Management Group? It covers the analysis, prioritisation and assessment - and the word "monitoring" is not used. |
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