Signal Detection at the MHRA - Pipa

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Signal detection & prioritisation processSignal detectionImpact AnalysisRPPSSignal detectionmeeting(s)Signal managementreview meetingSignal evaluationRegulatory actionSlide 18September 2009Crown Copyright ©
Interaction with EMEA/Eudravigilance• UK ADR reports are exchanged with the EMEA on a weeklybasis• MHRA makes use of Eudravigilance as an additional datasource for signal evaluation on an ad hoc basis• Signals currently shared with EMEA/Rapporteur/RMS forcentralised products where UK is not Rapporteur/RMS• Proposals to share signal information with EMEA in futureSlide 19September 2009Crown Copyright ©
Page 1 and 2: Safeguarding public healthSignal De
Page 3 and 4: The Yellow Card Scheme• Spontaneo
Page 5 and 6: Automated Signal Detection• Tradi
Page 7 and 8: Signal Detection Process at MHRA•
Page 9 and 10: UK Reports - Signal Criteria (Non-
Page 11 and 12: Non-UK Reports - Signal Criteria (N
Page 13 and 14: What do we do with a signal?• Nex
Page 15 and 16: Impact analysis : inputs• Summari
Page 17: RPPS - basic structure• Four cate
Page 21 and 22: Signal Communication Pilot Study -R
Page 23: Crown copyright 2009The materials f

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