WhitePaperEnhancingPatientSafety:AParadigmShiftThroughEarlyAIAdoptioninPharmacovigilanceWorkflowsJOANNEVANGELISTA,HeadofOperations&Innovations,USPatientSafetyGenentechMEREDITHKILEY,SeniorManagerOperations&Innovations,USPatientSafetyGenentechMARIEFLANAGAN,DirectorofOfferingManagement,IQVIAVigilanceDetectTableofcontentsIntroduction3AcalltorethinkPatientSupportPrograms(PSPs)3ATHENAinitiativeoverview:collaborativeinnovation4PatientsafetydatadistillingthroughthePVworkflowfaster4Shapingapatient-centricapproach5Thetechnologicalcore:IQVIAVigilanceDetect5Supervisedlearningforcontinuousenhancement5Impactevaluation:unveilingoperationalefficiency6Upstreamimpact6Downstreamimpact6Qualitativeimpact7Navigatingchallenges:thepathforward7Conclusion7Introductioninteraction.Thegoalwasclear–todecreasetheriskofmissedadverseeventsduetohumanerrorandenhanceInthehigh-stakes,ever-evolvinglandscapeofpatientsafetyoutcomes.pharmacovigilance(PV),theimperativetoensurepatientsafetyisspurringinnovativeapproaches.TraditionalPVAcalltorethinkAEreportinginPatientoperationstypicallystartat‘CaseProcessing,’buttheSupportPrograms(PSPs)persistentchallengeofunderreportedadversedrugreactions(ADRs)demandsaparadigmshift.TheFDA’sPatientSupportPrograms(PSPs),whilerichinvaluableestimatethatonly1–10%ofADRsreachtheAdversedata,havetraditionallybeenoverlooke...
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