Signal Detection at the MHRA - Pipa

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Examples of Alert TermsAgranulocytosisAlveolitisAplastic anaemiaBlindnessEosinophilia-myalgia syndromeFibrosing colonopathyHepatic necrosisHepatic failureHyperpyrexiaInsterstitial nephritisLimb reduction defectMalignant hyperthermiaMyocarditisNeuroleptic malignant syndromePulmonary fibrosisRenal failure acuteReye’s syndromeRhabdomyolysisStevens-Johnson syndromeSystemic lupus erythematosusThrombocytopeniaTorsade de pointesToxic epidermal necrolysisSuicideSuicidal ideationSelf-injurious behaviourIntentional overdoseDrug interactionFood interactionSlide 10September 2009Crown Copyright ©
Non-UK Reports - Signal Criteria (Non-▼)• All serious unlisted reports where EBGM ≥2.5, EB05 ≥1.8,n ≥5• All fatal reports• All reports involving children (≤16 years)• All parent/child reports (including spontaneous abortion)• All reports for ‘Alert’ terms - medical conditions of interestSlide 11September 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: UK Reports - Signal Criteria (Non-
Page 13 and 14: What do we do with a signal?• Nex
Page 15 and 16: Impact analysis : inputs• Summari
Page 17 and 18: RPPS - basic structure• Four cate
Page 19 and 20: Interaction with EMEA/Eudravigilanc
Page 21 and 22: Signal Communication Pilot Study -R
Page 23: Crown copyright 2009The materials f

Signal Detection at the MHRA - Pipa

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