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1、1基于产品质量的风险评估原则H.GreggClaycamp,Ph.D.,CHPCenterforVeterinaryMedicineOfficeofNewAnimalDrugEvaluationhclaycam@cvm.fda.govJune25,20032提纲总前提和问题风险分析的基本要素实施PQ的风险评估的可能阶段实施的风险分级模式?中试放大结论TheopinionsandideaspresentedherearethoseoftheauthoranddonotrepresentpolicyoropinionoftheFDA.Thismaterialisintendedfordisc
2、ussionpurposesonly.3前提:工艺中的风险和患者的风险的联系已丢失.风险工艺检查风险cGMP风险质量(患者)因素患者相互关系?模型?4目标:重新将cGMP(PQ)风险和对患者的实际风险联系起来风险工艺检查中的风险风险质量(患者)因素cGMP患者5问题…CanRiskManagementtheory,tools,practiceandphilosophybeemployedtore-linkriskstothepatientwiththerisksidentified,perceivedorotherwiseimplicatedinproductqualityte
3、rms?风险管理理论,工具,实践和哲学Howcanweshareacommonlanguageaboutrisk,riskmanagement,andscience-baseddecisionmakingsothatwecanfocusondevelopingahigh-qualityriskmanagementmodelforproductquality?6GettingStarted…Whattheories,toolsandlessonslearnedinriskanalysiscanhelpaddressthesequestions?Giventheneedforasignifi
4、cantshiftintheapproachtoriskmanagement,howdowebeginthechangeprocess?Arethereoff-the-shelfmodelsandtoolsthatmightbeused,i.e.,atapilot-scale?WhatkindsofRMprocessescanbeusedtofosterchangesneededboththeregulatoryandindustrialspheres?7基本风险分析8StartingwiththeSomeBasicsRiskisintuitiveandfamiliartoeveryon
5、e,yetfewamongusdefineriskcarefullyandformallyenoughforcomplexriskanalysis.exposureexposureseverityprobabilityharmhazardchanceseverityvalueprobabilitychance9风险=“暴露程度相对于损失的机会”(或者,风险=“chanceoflosingsomething wevalue”)风险=危害x暴露程度风险后果=危害x暴露程度10同时期的风险分析主要包括四大行动:危害识别风险评估风险管理风险交流11风险管评估先于风险管理Riskassessmen
6、tisnotasingleprocess,but“asystematicapproachtoorganizingandanalysingscientificknowledgeandinformation”tosupportariskdecision.NRC(1994)Variousparadigmsexistfortheexecutionofariskassessmentinpublichealth;however,allparadigmshaveincommonfundamentalscientificprinciples.12风险评估需要问以下问题:什么会出错?出错的可能性是什么?后
7、果是什么?13风险管理需要问以下问题:可以做什么?那些方法是可用的?就风险、利益和成本而言什么是风险的交易物?目前的对将来的管理决定的影响是什么?14Roles/Tasks(--shortlist)Posetheriskquestion.ChargetheRiskAssessorswiththeRiskAssessmentTask.Convenestakeholders.Analyzedecisionoptions.Make/rec
