PDA和全球制药工业(Robert-Dana)课件

PDA

ConnectingPeople,ScienceandRegulation®PDA

ConnectingPeople,SciencePDAandtheGlobalPharmaceuticalMarketPresentedatthe2011ParenteralDrugIndustryCongress,Beijing,ChinaSeptember2011PDAandtheGlobalPharmaceutiPDAandtheGlobalPharmaceuticalMarketAboutPDATheGlobalPharmaceuticalMarketSummaryPDAandtheGlobalPharmaceuti4AgendaAboutPDAWhoarewe?OurVision,Mission&FocusOurActivitiesMemberCoreCompetenciesMemberBenefits4AgendaAboutPDA5Weare:

Acommunityof9,500individualmemberscientistsandprofessionalsin70countriesrepresentinglargeandsmallpharmaceuticalandbiopharmaceuticalcompanies,regulatoryagencies,suppliersandacademia.5Weare: Acommunityof9,5006OurVision

Tobetheforemostglobalproviderofscience,technology,andregulatoryinformationandeducationforthepharmaceuticalandbiopharmaceuticalcommunity.6OurVision Tobetheforemost7OurMissionTodevelopscientificallysound,practicaltechnicalinformationandresourcestoadvancescienceandregulationforthepharmaceuticalandbiopharmaceuticalindustrythroughtheexpertiseofourglobalmembership.7OurMissionTodevelopscienti8StrategicFocus

8StrategicFocus9OurActivities(Volunteers)Over1,000PDAvolunteersworldwideactivelycarryoutitsmission.PDAisaninfluentialvoiceandaleadingtechnicalorganizationinthefieldofpharmaceuticalscienceandtechnology.ThroughthedevelopmentofTechnicalReportsandresponsestoregulatoryinitiatives,PDAanditsmembersinfluencethefuturecourseofpharmaceutical/biopharmaceuticalproductstechnology.99OurActivities(Volunteers)Ov10IntheareasofScienceandTechnology,PDAinfluencesindustrydirection

DevelopspositionsoncurrentandproposedapplicationsoftechnologyRootedinscienceConsensusdrivenRepresentindustrybestpracticesIdentifiesandmonitorsnewtechnologiesOurActivities(SciTech)10IntheareasofScienceandO11SupportstheapplicationoftechnologyandcompliancerequirementsthroughmembershipparticipationScienceAdvisoryBoard(SAB)BiotechnologyAdvisoryBoard(BioAB)RegulatoryAffairsandQualityAdvisoryBoard(RAQAB)InterestGroups(IGs)TaskForces(TFs)OurActivities(SciTech)Cont.11Supportstheapplicationof12PDAInterestGroupsarealignedtoAdvisoryBoardsInterestGroupsBIOABSABRAQABBiotechnologyBlowFillSealClinicalTrialMaterialsCombinationProductsFacilitiesandEngineeringInspectionTrendsLyophilizationFiltrationQualityRiskManagementPharmaceuticalColdChainMicrobiology/EMQualitySystemsVaccinesPackagingScienceRegulatoryAffairsPharmaceuticalWaterSystemsPrefilledSyringesProcessValidationSterileProcessingSupplyChainManagementTechnologyTransferVisualInspection1212PDAInterestGroupsarealig13OurActivities(TRs)TechnicalReportsMeantasrecommendation,andguidance,butarenon-prescriptive

However:MostreadanduseddocumentsbyregulatorsandindustryTRshaveinfluencedregulatoryGuidances,e.g.FDA’s2004AsepticGuideline,ISO13408-2andPIC/SAsepticGuide.13OurActivities(TRs)TechnicaNewTechnicalReports(2010and2011YeartoDate)TR47-PreparationofVirusSpikesUsedforVirusClearanceStudiesTR48-MoistHeatSterilizerSystems:Design,Commissioning,Operation,QualificationandMaintenanceTR49-PointstoConsiderforBiotechnologyCleaningValidationTR50-AlternativeMethodsforMycoplasmaTestingTR51-BiologicalIndicatorsforGasandVapor-PhaseDecontaminationProcesses:Specification,Manufacture,ControlandUseTR52-GuidanceforGoodDistributionPracticesforthePharmaceuticalSupplyChainTR53–GuidanceforIndustry:StabilityTestingtoSupportDistributionofNewDrugProductsNewTechnicalReports(2010an15OurActivities

(Regulations)MonitorGlobalRegulatoryActivityPrimaryFocus:U.S.andEuropeanRegulatoryAgenciesIncludesICH,PIC/S,USP,EPandWHODevelopinginterestinAsiaandIndia

InfluenceGlobalRegulatoryPolicyInteractionswithglobalregulatoryauthoritiesCo-sponsormeetingswithRegulators(FDA,EMA,PIC/S,ICH)CommentsonproposedregulationsandguidancePromotescience-basedregulations15OurActivities(Regulations)OurActivities(PCMOSM)16Scope UtilizingPDA’smembershipexpertisetodrive:theestablishmentof“bestpractice”documentstrainingeventsandcoursestoaidthepharmaceuticalmanufacturers’toimplementICHQ8,Q9andQ10IMPandcommercialproductsSeeourprojectdossieronthePDAwebsite(/pcmo)

formoreinformationOurActivities(PCMOSM)16Scope17OurActivities(PCMOSM)Objectives

EnableaninnovativeenvironmentforcontinualimprovementofproductsandsystemsPutscienceintopracticeEnableincreaseofprocessrobustnessandknowledgeFosterrelieffromregulatoryprescriptions17OurActivities(PCMOSM)ObjecPCMOProjectsLifecycleIMPmanufactureanddistributionImplementationofQbDinManufacturingTechnologyTransferSupplyChain/GoodDistributionPracticesQualitySystemsCapturingknowledgemanagementduringcommercialmanufacturingManagementofSuppliersandContractorsEstablishingaPharmaceuticalQualitySystemConceptsfortrainingPCMOProjectsLifecycleAdditionalPCMOProjectsProcessFromProcessValidationtoProcessVerificationConceptsforCleaningValidationHowtoimproverobustnessofamanufacturingprocessUtilizationofstatisticalmethodsforproductionandbusinessprocessesCorrectiveandpreventiveactionsRiskManagementRiskBasedManufacturingSterileAPIsRisk-BasedschedulingofauditsAdditionalPCMOProjectsProces20OurActivities(Conferences)World-classevents

Designedto

EducatePromoteinteractionAdvancememberinterestsGlobalvenuesScienceandRegulatoryfocus20OurActivities(Conferences)21OurActivities(TRI)State-of-the-arttrainingfacilityLearninginariskfreeenvironmentPDATraining&ResearchInstitute21OurActivities(TRI)State-of22TheTRICurriculum

ValidationLyophilizationPre-filledSyringesSterilizationTechnologyColdChainVisualInspectionAsepticProcessingBiotechnologyEnvironmentalMonitoringFiltrationMicrobiologyQuality/RegulatoryAffairsIncludescoursesin:22TheTRICurriculumValidatio23PDA’sStateoftheArtTrainingFacilityandRemoteCoursesBringConsistencyWorldwidePDAhasprovidedInspectorate

Trainingtoanumberofcountries Themostrecentare:RussiaKazakhstanEMAandmanyoftheEUInspectorate-Italy,UK,Ireland,Sweden,etc.USFDATraininghasbeenconductedinRussianandChineselanguages23PDA’sStateoftheArtTrainOurActivities(Membership)MembershipcompetenciesMembershipbenefitsNewmembershipcategoryforemergingeconomies24OurActivities(Membership)Mem25MembershipCoreCompetenciesAppliedSciencesAsepticProcessingManufacturingProcessEngineeringBiotechnologyMicrobiologyProcessValidation25QualityandRegulatoryRegulatory Compliance/GMPSupplyChainQualitySystems25MembershipCoreCompetencies26MembershipBenefitsProfessionalResources&NetworkInterestGroupsTaskForcesChaptersCareerServiceCenterStudentScientificProgramsSci-TechDiscussionGroupOnlineMembershipDirectory26MembershipBenefitsProfessio27PublicationsPDAJournalofPharmaceuticalScience&TechnologyPDALetterTechnicalReportsBooksandScientificPublicationsMembershipBenefits(Cont.)27PublicationsMembershipBenef28PDAJournalWebsiteJournalHighWirewebsitelaunchedin2009EasytouseandsearchArchivesbackto1998MorefeaturestocomeNewJournalEditorialStaffonboardRenewedemphasisoncorePDAmemberinterestsBiotech,Microbiology,AsepticProcessingandManufacturingarticlesdesired28PDAJournalWebsiteJournalHNewReducedCostMembershipForemergingeconomies(includingChina)Electronicaccessto:PDAJournalwebsite,currentandprioryearPDALetterPDAmembershipdirectoryNoaccessto:ElectronicTechnicalReportsPrintversionofPDALetterAnnualCost:$100.00[canupgradetofullmembershipforadditional$149.00(total$249)]NewReducedCostMembershipFor30SummaryPDAoffersauniquenetworkandplatformtoexchangeknowledgeandexperiencesPDAhasstrongrelationshipswithglobalregulatorsandstandardsettingorganizationsanditsTechnicalReportsarewelcomedPDAservestheindustrywithbyinfluencingscientific,technological®ulatorytrendsPDAistheorganizationforparenterals30SummaryPDAoffersauniquenTheGlobalPharmaceuticalMarketAgendaBusinessEnvironmentPharmaManufacturingEnvironmentRegulatoryEnvironmentClosingThoughtsTheGlobalPharmaceuticalMark32BusinessChangesinPharmaDependenceonBlockbustersEmergingMarketsLossofPatentProtectionConsolidation/Mergers&Acquisitions32BusinessChangesinPharmaDe33DependenceonBlockbusters33DependenceonBlockbusters34DiversificationviaGeographicExpansion

Emergingmarkets–shareofglobalpharmagrowth:

Source;IMSHealth34DiversificationviaGeograph35Patent“Cliff”35Patent“Cliff”36RecentPharmaMergersandAcquisitions36RecentPharmaMergersandAc37Processeshavebeenevolving…Frommortarandpestletohighlycomplexbioreactors.Frommanuallyintensiveasepticprocessestohighlyautomatedequipmentwithadvancedenvironmentalcontrols.FromtesttubestoRamanspectroscopy.FromPenandPapertoGigabytesofelectronicdata.37Processeshavebeenevolving38ThePharmaceuticalSupplyChainhasbecomemorecomplexGlobalizationofSupplyChainMoreoff-shoresourcinganddistributionIncreasedpercentageof“coldchain”productsIncreaseindiversion,counterfeitingand“economicallymotivatedadulteration”38ThePharmaceuticalSupplyCh39Ourconceptofqualityhaschanged…FromtestandreleasetoQualityAssurancetoQualitybyDesign.From‘craftmanship’tovalidatedprocesses.FromR&D/Manufacturing/QualitysilostoQualitySystemApproachthatreachesfrombeginningofnewproductsthroughoutthelifecycle.39Ourconceptofqualityhasc40Ourregulatoryframeworkhasalsochanged…30yearsago:Highlyfragmented,lackofconsistency,20yearsago:BeginningsofEUintegrationandinternationalharmonization.TodayAdvancesinInternationalHarmonizationTomorrowGreatercooperationandexchangeofinformationamongglobalregulators40Ourregulatoryframeworkhas41ChallengesforthePharmaceuticalIndustryinthe21stCenturyGlobalizationRationalizationIntegrationCostReductionSupplyChainIntegrityAlladduptoincreasedComplexity41ChallengesforthePharmaceu42GlobalizationRationalizationofManufacturingcapacityisoccurringatthesametimethatglobaldemandforpharmaceuticalsisrising.Growthrateismostnoticeablein“pharmerging”marketsChina,Brazil,Mexico,SouthKorea,India,TurkeyandRussiavs.US/EU/JapanCostpressuresaredrivingmoremanufacturingto“pharmerging”countries42GlobalizationRationalization43RationalizationPharmamanufacturinghasover-capacityReductionoffacilitiesisongoingImpactisgreatestinUSandEuropeProductrationalizationisongoingatmajorpharma43RationalizationPharmamanufa44IntegrationIntegratingmergerpartnersIntegratingCROsandCMOsIntegratingSuppliersAPIsExcipientsPackagingComponentsKeyManufacturingmaterials44IntegrationIntegratingmerge45CostReductionDeclineintop-linerevenueaddspressureonPharmacompaniestoreduceexpensestomaintainbottomlinerevenueRationalizationofovercapacityPricingpressureonmaterialsandCostofGoodsGovernmentpricingpressureisincreasingworldwide45CostReductionDeclineintop46SupplyChainIntegrityEnhancingSupplierQualityManagementsupplierselectionandqualificationprocesses,on-goingmonitoringandmanagement.IncreasingSupplyChainControlsforincomingmaterialsandcomponents,supplyroutesecurityandverification,verificationofincomingcomponentsandmaterialsandauthenticationofsupportingdocumentation.46SupplyChainIntegrityEnhanc47SupplyChainIntegrityImprovingAnalysisandTestingStrategiesandTechnologiestoimprovethedetectionofadulterantsMonitoringandRespondingtoSignalsintheMarketplaceandassessingtheriskofthemarket/environment,including:economicallymotivatedadulterationrisks,aswellasalert,responseandcommunicationatlocalandgloballevel.47SupplyChainIntegrityImprov48Thechallengesthatweasanindustryfacearemany.PDAasanAssociationfacesthesechallengesbesideyou.WeinviteyoutobecomeanactivePDAmemberWithyoursupportandparticipation,wewillcontinueConnectingPeople,ScienceandRegulation.Closingthoughts48Thechallengesthatweasan49Thankyou

foryourtimeandattention

49Thankyou

foryourtimeand50PDAContactInfo:

PDAUSAMemberRelations:4350EastWestHwy.Suite200,Bethesda,MDUSAinfo@or301-656-5900PDAEuropeMemberRelations:

Adalbertstr.9,16548Glienicke/Berlin,GermanyTel:+49330562377-0or-10orFax:+49330562377-77or-15info-europe@Speaker’sContactInformation:RobertL.Dana,SeniorVicePresident,PDAdana@

50PDAContactInfo:PDA

ConnectingPeople,ScienceandRegulation®PDA

ConnectingPeople,SciencePDAandtheGlobalPharmaceuticalMarketPresentedatthe2011ParenteralDrugIndustryCongress,Beijing,ChinaSeptember2011PDAandtheGlobalPharmaceutiPDAandtheGlobalPharmaceuticalMarketAboutPDATheGlobalPharmaceuticalMarketSummaryPDAandtheGlobalPharmaceuti54AgendaAboutPDAWhoarewe?OurVision,Mission&FocusOurActivitiesMemberCoreCompetenciesMemberBenefits4AgendaAboutPDA55Weare:

Acommunityof9,500individualmemberscientistsandprofessionalsin70countriesrepresentinglargeandsmallpharmaceuticalandbiopharmaceuticalcompanies,regulatoryagencies,suppliersandacademia.5Weare: Acommunityof9,50056OurVision

Tobetheforemostglobalproviderofscience,technology,andregulatoryinformationandeducationforthepharmaceuticalandbiopharmaceuticalcommunity.6OurVision Tobetheforemost57OurMissionTodevelopscientificallysound,practicaltechnicalinformationandresourcestoadvancescienceandregulationforthepharmaceuticalandbiopharmaceuticalindustrythroughtheexpertiseofourglobalmembership.7OurMissionTodevelopscienti58StrategicFocus

8StrategicFocus59OurActivities(Volunteers)Over1,000PDAvolunteersworldwideactivelycarryoutitsmission.PDAisaninfluentialvoiceandaleadingtechnicalorganizationinthefieldofpharmaceuticalscienceandtechnology.ThroughthedevelopmentofTechnicalReportsandresponsestoregulatoryinitiatives,PDAanditsmembersinfluencethefuturecourseofpharmaceutical/biopharmaceuticalproductstechnology.599OurActivities(Volunteers)Ov60IntheareasofScienceandTechnology,PDAinfluencesindustrydirection

DevelopspositionsoncurrentandproposedapplicationsoftechnologyRootedinscienceConsensusdrivenRepresentindustrybestpracticesIdentifiesandmonitorsnewtechnologiesOurActivities(SciTech)10IntheareasofScienceandO61SupportstheapplicationoftechnologyandcompliancerequirementsthroughmembershipparticipationScienceAdvisoryBoard(SAB)BiotechnologyAdvisoryBoard(BioAB)RegulatoryAffairsandQualityAdvisoryBoard(RAQAB)InterestGroups(IGs)TaskForces(TFs)OurActivities(SciTech)Cont.11Supportstheapplicationof62PDAInterestGroupsarealignedtoAdvisoryBoardsInterestGroupsBIOABSABRAQABBiotechnologyBlowFillSealClinicalTrialMaterialsCombinationProductsFacilitiesandEngineeringInspectionTrendsLyophilizationFiltrationQualityRiskManagementPharmaceuticalColdChainMicrobiology/EMQualitySystemsVaccinesPackagingScienceRegulatoryAffairsPharmaceuticalWaterSystemsPrefilledSyringesProcessValidationSterileProcessingSupplyChainManagementTechnologyTransferVisualInspection6212PDAInterestGroupsarealig63OurActivities(TRs)TechnicalReportsMeantasrecommendation,andguidance,butarenon-prescriptive

However:MostreadanduseddocumentsbyregulatorsandindustryTRshaveinfluencedregulatoryGuidances,e.g.FDA’s2004AsepticGuideline,ISO13408-2andPIC/SAsepticGuide.13OurActivities(TRs)TechnicaNewTechnicalReports(2010and2011YeartoDate)TR47-PreparationofVirusSpikesUsedforVirusClearanceStudiesTR48-MoistHeatSterilizerSystems:Design,Commissioning,Operation,QualificationandMaintenanceTR49-PointstoConsiderforBiotechnologyCleaningValidationTR50-AlternativeMethodsforMycoplasmaTestingTR51-BiologicalIndicatorsforGasandVapor-PhaseDecontaminationProcesses:Specification,Manufacture,ControlandUseTR52-GuidanceforGoodDistributionPracticesforthePharmaceuticalSupplyChainTR53–GuidanceforIndustry:StabilityTestingtoSupportDistributionofNewDrugProductsNewTechnicalReports(2010an65OurActivities

(Regulations)MonitorGlobalRegulatoryActivityPrimaryFocus:U.S.andEuropeanRegulatoryAgenciesIncludesICH,PIC/S,USP,EPandWHODevelopinginterestinAsiaandIndia

InfluenceGlobalRegulatoryPolicyInteractionswithglobalregulatoryauthoritiesCo-sponsormeetingswithRegulators(FDA,EMA,PIC/S,ICH)CommentsonproposedregulationsandguidancePromotescience-basedregulations15OurActivities(Regulations)OurActivities(PCMOSM)66Scope UtilizingPDA’smembershipexpertisetodrive:theestablishmentof“bestpractice”documentstrainingeventsandcoursestoaidthepharmaceuticalmanufacturers’toimplementICHQ8,Q9andQ10IMPandcommercialproductsSeeourprojectdossieronthePDAwebsite(/pcmo)

formoreinformationOurActivities(PCMOSM)16Scope67OurActivities(PCMOSM)Objectives

EnableaninnovativeenvironmentforcontinualimprovementofproductsandsystemsPutscienceintopracticeEnableincreaseofprocessrobustnessandknowledgeFosterrelieffromregulatoryprescriptions17OurActivities(PCMOSM)ObjecPCMOProjectsLifecycleIMPmanufactureanddistributionImplementationofQbDinManufacturingTechnologyTransferSupplyChain/GoodDistributionPracticesQualitySystemsCapturingknowledgemanagementduringcommercialmanufacturingManagementofSuppliersandContractorsEstablishingaPharmaceuticalQualitySystemConceptsfortrainingPCMOProjectsLifecycleAdditionalPCMOProjectsProcessFromProcessValidationtoProcessVerificationConceptsforCleaningValidationHowtoimproverobustnessofamanufacturingprocessUtilizationofstatisticalmethodsforproductionandbusinessprocessesCorrectiveandpreventiveactionsRiskManagementRiskBasedManufacturingSterileAPIsRisk-BasedschedulingofauditsAdditionalPCMOProjectsProces70OurActivities(Conferences)World-classevents

Designedto

EducatePromoteinteractionAdvancememberinterestsGlobalvenuesScienceandRegulatoryfocus20OurActivities(Conferences)71OurActivities(TRI)State-of-the-arttrainingfacilityLearninginariskfreeenvironmentPDATraining&ResearchInstitute21OurActivities(TRI)State-of72TheTRICurriculum

ValidationLyophilizationPre-filledSyringesSterilizationTechnologyColdChainVisualInspectionAsepticProcessingBiotechnologyEnvironmentalMonitoringFiltrationMicrobiologyQuality/RegulatoryAffairsIncludescoursesin:22TheTRICurriculumValidatio73PDA’sStateoftheArtTrainingFacilityandRemoteCoursesBringConsistencyWorldwidePDAhasprovidedInspectorate

Trainingtoanumberofcountries Themostrecentare:RussiaKazakhstanEMAandmanyoftheEUInspectorate-Italy,UK,Ireland,Sweden,etc.USFDATraininghasbeenconductedinRussianandChineselanguages23PDA’sStateoftheArtTrainOurActivities(Membership)MembershipcompetenciesMembershipbenefitsNewmembershipcategoryforemergingeconomies74OurActivities(Membership)Mem75MembershipCoreCompetenciesAppliedSciencesAsepticProcessingManufacturingProcessEngineeringBiotechnologyMicrobiologyProcessValidation75QualityandRegulatoryRegulatory Compliance/GMPSupplyChainQualitySystems25MembershipCoreCompetencies76MembershipBenefitsProfessionalResources&NetworkInterestGroupsTaskForcesChaptersCareerServiceCenterStudentScientificProgramsSci-TechDiscussionGroupOnlineMembershipDirectory26MembershipBenefitsProfessio77PublicationsPDAJournalofPharmaceuticalScience&TechnologyPDALetterTechnicalReportsBooksandScientificPublicationsMembershipBenefits(Cont.)27PublicationsMembershipBenef78PDAJournalWebsiteJournalHighWirewebsitelaunchedin2009EasytouseandsearchArchivesbackto1998MorefeaturestocomeNewJournalEditorialStaffonboardRenewedemphasisoncorePDAmemberinterestsBiotech,Microbiology,AsepticProcessingandManufacturingarticlesdesired28PDAJournalWebsiteJournalHNewReducedCostMembershipForemergingeconomies(includingChina)Electronicaccessto:PDAJournalwebsite,currentandprioryearPDALetterPDAmembershipdirectoryNoaccessto:ElectronicTechnicalReportsPrintversionofPDALetterAnnualCost:$100.00[canupgradetofullmembershipforadditional$149.00(total$249)]NewReducedCostMembershipFor80SummaryPDAoffersauniquenetworkandplatformtoexchangeknowledgeandexperiencesPDAhasstrongrelationshipswithglobalregulatorsandstandardsettingorganizationsanditsTechnicalReportsarewelcomedPDAservestheindustrywithbyinfluencingscientific,technological®ulatorytrendsPDAistheorganizationforparenterals30SummaryPDAoffersauniquenTheGlobalPharmaceuticalMarketAgendaBusinessEnvironmentPharmaManufacturingEnvironmentRegulatoryEnvironmentClosingThoughtsTheGlobalPharmaceuticalMark82BusinessChangesinPharmaDependenceonBlockbustersEmergingMarketsLossofPatentProtectionConsolidation/Mergers&Acquisitions32BusinessChangesinPharmaDe83DependenceonBlockbusters33DependenceonBlockbusters84DiversificationviaGeographicExpansion

Emergingmarkets–shareofglobalpharmagrowth:

Source;IMSHealth34DiversificationviaGeograph85Patent“Cliff”35Patent“Cliff”86RecentPharmaMergersandAcquisitions36RecentPharmaMergersandAc87Processeshavebeenevolving…Frommortarandpestletohighlycomplexbioreactors.Frommanuallyintensiveasepticprocessestohighlyautomatedequipmentwithadvancedenvironmentalcontrols.FromtesttubestoRamanspectroscopy.FromPenandPapertoGigabytesofelectronicdata.37Processeshavebeenevolving88ThePharmaceuticalSupplyChainhasbecomemorecomplexGlobalizationofSupplyChainMoreoff-shoresourcinganddistributionIncreasedpercentageof“coldchain”productsIncreaseindiversion,counterfeitingand“economicallymotivatedadulteration”38ThePharmaceuticalSupplyCh89Ourconceptofqualityhaschanged…FromtestandreleasetoQualityAssurancetoQualitybyDesign.From‘craftmanship’tovalidatedprocesses.FromR&D/Manufacturing/QualitysilostoQualitySystemApproachthatreachesfrombeginningofnewproductsthroughoutthelifecycle.39Ourconceptofqualityhasc90Ourregulatoryframeworkhasalsochanged…30yearsago:Highlyfragmented,lackofconsistency,20yearsago:BeginningsofEUintegrationandinternationalharmonization.TodayAdvancesinInternationalHarmonizationTomorrowGreatercooperationandexchangeofinformationamongglobalregulators40Ourregulatoryframeworkhas91ChallengesforthePharmaceuticalIndustryinthe21stCenturyGlobalizationRationalizationIntegrationCostReductionSupplyChainIntegrityAll