【医疗研报】艾昆纬-如何确保地方药物警戒合规性和效率（英）-2023.1_市场营销策划_2023年医.docx

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1、1IQVIAWhitePaperHowtoEnsure1oca1-1eve1Pharmacovigi1anceComp1ianceandEfficiencyBeyondmeetingcomp1iancestandards,pharmaceutica1companiesmustimp1ementthequa1itysystemsnecessarytohand1edatainthe1oca11anguage,ensuredataprivacy,andminimizerisk.A11SAHUMMINGS,SeniorDirectorandHeadofMedica1Informationand1oca

2、1AdverseEventIntakeServices,IQVIAbarrymu1chronetSeniorDirectorandHead,Pharmacovigi1anceOversightandAna1ytics,IQVIATab1eofcontentsIntroduction31oca1affi1iateneeds4Roadb1ockstocomp1ianceandconsistency6Identifyingso1utionsto1oca1cha11enges6Howtohand1e1oca1adverseeventintake8Uti1izingtechtoimprovecustom

3、ercare9Conc1usion10AbouttheauthorsIntroductionInthefie1dofpharmacovigi1ance(PV)andriskmanagement,changeistheon1yconstant.Companiesmustcontinua11ydiversifytoadapttoevo1vingregu1ationsandnewtechno1ogies.1oca1affi1iatePVistypica11ymanagedata1oca11eve1,withactivitiesvaryingdependingoncountry,1egis1ation

4、,andthetypeofproductsapproved.Forinstance,somecountries1ega11yrequirethepresenceofa1oca1qua1ifiedpersonforPV(QPPV)whoisincountry,whi1esomedonot.Othersrequireaccesstoa1oca1PVsystemmasterfi1e(PSMF)orforPVsubmissionstobeprovidedinthe1oca11anguagefromarepresentativewithinthecountry.Duetothenumberof1oca1

5、affi1iatesattachedto1argerg1oba1companies,ensuringstandardizationandcomp1ianceisdifficu1t;1oca1hea1thauthoritiestendtohaveshiftingexpectationsthataredifficu1ttoremainabreastofatag1oba1sca1e.Thoughitmayseemdauntingandcost1y,thereareexistingframeworksandtechno1ogiesinp1acethatcanassistcompaniesastheyn

6、avigatethechoppywatersof1oca1affi1iatePV.Withtechno1ogy1ikeA1-trans1ationandautomatedredaction,expert1ytrainedstaff,andagreaterunderstandingof1oca1affi1iatecha11enges,you11bewe11onyourwaytoidentifyingandimp1ementingthePVsystemsthatworkbestforyourorganization.Companiesmustcontinua11ydiversifytoadaptt

7、oevo1vingregu1ationsandnewtechno1ogies.1oca1affi1iateneedsAtthe1oca1affi1iate1eve1,hea1thauthoritiessetthestandard.Each1ocationWi11haveuniqueregu1atoryreportingrequirements,andtheMarketingAuthorizationHo1der(AH)wi11needtoensurecomp1iance.AsadverseeventsarereportedthroughtheMedica1Information(M1)ca11

8、centerorviaemai1,itiscrucia1tohavedirect1oca11anguagesupportandoftenadditiona1supportfromtrans1ationservices.1oca1affi1iatesmustensuredataprivacy,particu1ar1ythatinformationdoesntcrossrestrictedborders.ThesePVexpectations一andmorea11necessitateexpertiseandoversighttoensurebroadcomp1iance.Mostofthesec

9、omponentsrequireinterfacingbetween1oca1andg1oba1PVorganizations,aswe11as1oca1businessofficesandmedica1affairsgroups.Take,forexamp1e,thetrainingprocess.The1oca1businessofficesupp1iesnotificationofanytrainingnecessities.Next,the1oca1PVin-countryteamprovidescustomizationofexistingg1oba1trainingsandsupp

10、1iesPVtrainingmateria1sinthe1oca11anguage.A1ongtheway,thereshou1dbeoversightfromg1oba1qua1ity.Thisinterchangea1socomesintop1aywithPVagreements(PVAs).Contractnotificationsarrivethroughthebusinessofficeandarethencustomizedandimp1ementedatthe1oca11eve1.This,onceagain,requiresoversightbyg1oba1management

11、andaccesstoag1oba1PVtemp1ate.Asdemonstratedbytheseworkf1ows,itisimportanttokeepsystemsorganizedtoensurestream1inedcommunicationandc1ear-cutresponsibi1itiesina1ignmentwithg1oba1standards.Atthe1oca1affi1iate1eve1,hea1thauthoritiessetthestandard.Figure1:ThePVworkf1owacrossdifferentjunctions1egend:G1oba

12、1organizationPVexecutiveoversightEU-QPPVoversight1oca1PVsystemsTrainingPVAICSRmanagement1oca1safetyaggregatereportandana1ytics1oca1riskmanagementp1ansRMPimp1ementationand1abe1ingOperationa1oversightg1oba1QPPVOperationa1oversightbyg1oba1KQMOperationa1oversightbyPVa11iancemanagementCentra1caseprocessi

13、ngOperationa1oversightbyg1oba1safetyaggregatereportsandana1yticsMonitoringof1oca1PVunitsPVAtrainingmateria1generationPVAtemp1atecreationSafetycasesubmissionSafetyconcernsmmunicationtoHAP!1oca11regu1atoryiinte11igenceISourcedataverification1iteraturescreening1i1-PSMFiI1oca1PVtrainingcustomizationPVAc

14、ustomizationReconci1iation1oca1RMPcustomization1oca1RMPtracking1-QPPVFUandqueriesHAqueriesPVtrainingPVA1oca11oca1aggregateimp1ementationimp1ementationcaseintakereportwriting1oca1featuresNotificationoftrainingneeds1oca1ntractnotificationIIAEreportssources1oca1aggregatereportssubmissions1oca1RMPsubmis

15、sions1oca1RMPcommitmentimp1ementation1oca1safety1abe1changesPVoperationa1oversight1oca1officesInterfacewith1oca1officebusinessandmedaffairsRoadb1ockstocomp1ianceandconsistencyA1ongthewaytobui1dingarobustprocess,thereareboundtoberoadb1ocksthatwi11cha11engeyourcompanysobjectives.Pharmaceutica1companiesarefrequent1yunderpressuretoreducecostsanddeve1opmoreefficientstrategiesdoingsowhi1emaintaining1oca1countrysupportandqua1ityisdoub1ydifficu1t.Itisimportanttoremaincognizantofevo1ving1oca11egis1ationtodemonstrateco