《藥品GVP指南》中的術(shù)語對照表術(shù)語縮略語英文來源藥品不良事件ADEadverse

drugevent藥品GVP指南藥品不良反應(yīng)ADRadverse

drugreaction藥品GVP指南不良事件AEadverse

event藥品GVP指南業(yè)務(wù)連續(xù)性計(jì)劃BCPbusiness

continuityplan藥品GVP指南糾正措施和預(yù)防措施CAPAcorrective

actionandpreventiveaction藥品GVP指南生物制品評價(jià)與研究中心CBERCenter

forBiologicsEvaluation藥品GVP指南藥品評價(jià)與研究中心CDERCenter

forDrugEvaluationandResearch藥品GVP指南國際醫(yī)學(xué)科學(xué)組織理事會(huì)CIOMSCouncil

forInternationalOrganizationsofMedicalSciences藥品GVP指南合同研究組織CROcontract

researchorganization藥品GVP指南不相稱性測定分析法DAdisproportional

analysis藥品GVP指南國際數(shù)據(jù)管理協(xié)會(huì)DAMAData

ManagementAssociationInternationa!藥品GVP指南數(shù)據(jù)管理DMdata

management藥品GVP指南研發(fā)期間安全性更新報(bào)告DSURdevelopment

safetyupdatereport藥品GVP指南美國食品藥品管理局不良事件報(bào)告系統(tǒng)FAERSFDA

AdverseEventReportingSystem藥品GVP指南藥物警戒質(zhì)量管理規(guī)范GVPGood

PharmacovigilancePractice藥品GVP指南國際人用藥品注冊技術(shù)協(xié)調(diào)會(huì)ICHThe

InternationalCouncilforHarmonisationofTechnicalRequirementsfor

PharmaccuticalsforHumanUse藥品GVP指南個(gè)例安全性報(bào)告ICSRindividual

casesafetyreport藥品GVP指南干預(yù)性研究ISintervention

study藥品GVP指南國際標(biāo)準(zhǔn)化組織ISOInternational

StandardsOrganization藥品GVP指南關(guān)鍵績效指標(biāo)KPIkey

performanceindicator藥品GVP指南上市許可持有人MAHMarketing

AuthorizationHolder藥品GVP指南用藥錯(cuò)誤MEmedication

error藥品GVP指南監(jiān)管活動(dòng)醫(yī)學(xué)詞典MedDRAMedical

DictionaryforRegularActivities藥品GVP指南非干預(yù)性研究NISnon

interventionalstudy藥品GVP指南上市后安全性研究PASSpost-authorisation

safetystudy藥品GVP指南定期獲益-風(fēng)險(xiǎn)評估報(bào)告PBRERperiodic

benefit-riskevaluationreport藥品GVP指南處方事件監(jiān)測PEMprescription

eventmonitoring藥品GVP指南藥物警戒體系主文件PSMFpharmacovigilance

systemmasterfile藥品GVP指南定期安全性更新報(bào)告PSURperiodic

safetyupdatereport藥品GVP指南藥物警戒協(xié)議PVApharmacovigilance

agreement藥品GVP指南藥物警戒計(jì)劃PVPpharmacovigilance

plan藥品GVP指南質(zhì)量保證QAquality

assurance藥品GVP指南質(zhì)量控制QCquality

control藥品GVP指南藥物警戒負(fù)責(zé)人QPPVqualified

personresponsibleforpharmacovigilance藥品GVP指南風(fēng)險(xiǎn)控制計(jì)劃RCPRisk

ControlPlan藥品GVP指南風(fēng)險(xiǎn)最小化行動(dòng)計(jì)劃RiskMAPrisk

minimizationactionplan藥品GVP指南風(fēng)險(xiǎn)管理計(jì)劃RMPrisk

managementpaln其他嚴(yán)重不良事件SAEserious

adverseevent藥品GVP指南嚴(yán)重藥品不良反應(yīng)SARscrious

adversereaction藥品GVP指南安全性數(shù)據(jù)交換協(xié)議SDEAsafety

dataexchangeagreement藥品GVP指南安全管理計(jì)劃SMPsafety

managementplan藥品GVP指南標(biāo)準(zhǔn)操作規(guī)程SOPstandard

operationprocedure藥品GVP指南自發(fā)報(bào)告系統(tǒng)SRSspontancous

reportingsystem藥品GVP指南可疑且非預(yù)期嚴(yán)重不良反應(yīng)SUSARsuspect

unexpectedseriousadversereaction其他非預(yù)期藥物不良反應(yīng)UADRunexpected

adversedrugreaction其他黃卡制度YCSyellow

cardsystem其他藥物過敏反應(yīng)(變態(tài)反應(yīng))/allergic

reaction藥品GVP指南獲益風(fēng)險(xiǎn)平衡/benefit

riskbalance藥品GVP指南病例對照研究/case-control

study藥品GVP指南臨床試驗(yàn)/clinical

trial其他聚類分析/cluster

analysis藥品GVP指南隊(duì)列研究/cohort

study藥品GVP指南橫斷面研究/cross-sectional

study藥品GVP指南薈萃分析/meta

analysis藥品GVP指南觀察性研究/observational

study藥品GVP指南藥物警戒體系/pharmacovigilance

system藥品GVP指南上市后不良反應(yīng)監(jiān)測/post

marketingADRmonitoring藥品GVP指南潛在風(fēng)險(xiǎn)/potential

risk其他風(fēng)險(xiǎn)溝通/risk

communication藥品GVP指南風(fēng)險(xiǎn)控制措施/risk

controlmcasure(s)藥品GVP指南風(fēng)險(xiǎn)管理措施/risk

managementmeasure(s)藥品GVP指南風(fēng)險(xiǎn)最小化措施/risk

minimisationmeasure(s)藥品GVP指南哨點(diǎn)監(jiān)測/sentinel

surveillance藥品GVP指南副作用(副反應(yīng))/side

effects藥品GVP指南信號(hào)檢測/signal

detection藥品GVP指南重要不良事件/Significant

AdverseEvent藥品