强生制药公司病人管理规范营销

强生制药公司病人管理规范营销第1页/共85页第2页/共85页2004Salesof$47.3BillionOver200operatingcompaniesin57countriesaroundtheworldLeadershippositionsinethicalandOTCpharmaceuticals,medical/surgicalsupplies,diagnosticsandavarietyofconsumerproductsBroadbased,diverseportfolioofproducts

World’sMostComprehensiveandBroadlyBasedHealthCareCompany第3页/共85页ByGeographicAreaWorldwideNetTradeSales2004U.S.EuropeW.Hem(ex.US)AsiaPacific&Africa12%5%24%59%$47.3Billion第4页/共85页2004SalesbySegment46.7%17.6%35.7%MD&D$16.9BillionPharmaceutical$22.1BillionConsumer$8.3Billion第5页/共85页Indiana-basedcompanysellingproductsin100countriesaroundtheworldLeaderindesignandmanufactureofcardiacandvasculardevicesandtherapiesBusinessunitswithupto30yearsexperienceinkeymarketsOver12,000employeesworldwideGDTtradedontheNYSEandPCXGuidantCorporateProfile第6页/共85页GuidantCorporationStructureCRMVIESCSCARDIACRHYTHMMANAGEMENTENDOVASCULARSOLUTIONSCARDIACSURGERYVASCULARINTERVENTIONCOMPASSHeadquartersGeographicOperations第7页/共85页OverviewWhyareComplianceProgramsImportant?HistoryandBasicsoftheU.S.SentencingCommissionGuidelinesHHSOIGComplianceProgramGuidelinesComplianceProgramBasicsWrittenStandardsofConductLeadershipandInfrastructureEducationandTrainingInternalCommunicationsandReportingMonitoringandAuditingEnforcementofDisciplinaryStandardsRespondingtoDetectedOffensesConcludingThoughts第8页/共85页WhyAreComplianceProgramsImportant?

(Or…WhoCares?)Effectiveprogramscanpreventwrongdoingandlessenthedamagewhenviolationsdooccur.Acrediblecomplianceprogramcanbeinfluentialatkeystagesoftheinvestigativeandenforcementprocesses:WhethertocontinueorexpandaninvestigationWhethertoturninvestigatoryresultsovertoprosecutorsWhethertochargeacompanywithwrongdoingWhethertopursuecriminalorcivilchargesWhethertosettleacaseand,ifso,onwhattermsWhethertopursueexclusionordebarmentofacompany第9页/共85页U.S.SentencingCommissionGuidelinesThe1984SentencingReformActcreatedtheU.S.SentencingCommissionanddirectedittodevelopguidelinesforsentencingofindividualsandentitiesconvictedofFederalcrimes.Sentencingguidelinesforindividualswereissuedin1987.TheGuidelinesforOrganizations(includingcorporationsconvictedofFederalcrimes)wereissuedin1991.EffectundertheGuidelines:Aneffectivecomplianceandethicsprogramisoneofmitigatingfactorsthatcanreduceacompany’sfineAbsencemaybeareasontoplaceacorporationonprobationImplementationofaprogrammaybeconditionofprobation第10页/共85页USSCGuidelines(cont’d)Theoriginalguidelinesdefinedan“effectivecomplianceprogram”ashavingseven“elements”StandardsandproceduresforemployeesSpecifichigh-levelindividual(s)mustbeassignedoverallresponsibilityforcomplianceprogramExerciseofduecarenottodelegatesubstantialauthoritytoindividualsTrainingandcommunicationofstandardstoemployeesandagentsReasonablestepstoachievecompliance–boththroughauditingandmonitoringprogramsandinternalreportingsystemsConsistentenforcementofdisciplinarystandardsStepstorespondtoreportedmisconductandpreventfutureviolations第11页/共85页USSCGuidelines(cont’d)Recentamendments(effectiveNovember1,2004)strengthenedeachofthesevenelements(andarguablyaddedanewelement).Amongthemajorchanges:Complianceprogramsshouldbedesignedtoreasonablypreventanddetectallviolationsoflaw(notjustcrimes)Significantlyexpandsresponsibilityof“governingauthority,”includingarequirementto“otherwisepromoteanorganizationalculturethatencouragesethicalconductandacommitmenttocompliance…”Requires“high-levelpersonnel”tohaveultimateresponsibilityforprogramRequiresadequateresourcestoimplementtheprogramExtendstrainingrequirementtoalllevelsoftheorganizationRequiresperiodicevaluationofprogrameffectivenessAddsdutytopromoteprogramconductthroughincentivetoexistingrequirementtoensureenforcementofdisciplineforwrongdoing第12页/共85页USSCGuidelines(cont’d)Arguablyaddsnew“element”–arequirementtoimplementanon-goingprocesstoassesstheriskofviolationsandtotakestepstoaddresssuchrisksBolstersprovisionsrelatingto“smallorganizations”(definedasthosewithlessthan200employees)Statesthatwaiverofattorney-clientprivilegeandwork-productprotections“isnotaprerequisitetoareductioninculpabilityscore…unlesssuchwaiverisnecessaryinordertoprovetimelyandthoroughdisclosureofallpertinentinformationknowntotheorganization.”第13页/共85页IntroductiontoHHSOIGGuidelinesTheOIGhasissued“ComplianceProgramGuidances”for11healthcareindustrysectors–mostrecentlyforpharmaceuticalmanufacturers(May5,2003,68Fed.Reg.23731-43).ThePharmaceuticalGuidancestatesthatit“mayhaveapplicationtomanufacturersofotherproducts…suchasmedicaldevices....”EachGuidanceisvoluntaryand“representstheOIG’ssuggestions”onhowtoimplementacomplianceprogram.ThePharmaceuticalGuidancestates:“Thecontentsofthisguidanceshouldnotbeviewedasmandatoryorasanexclusivediscussionoftheadvisableelementsofacomplianceprogram.Thedocumentisintendedtopresentvoluntaryguidancetotheindustryandnottorepresentbindingstandardsforpharmaceuticalmanufacturers.”“Thisguideisnotacomplianceprogram.Rather,itisasetofguidelinesthat…manufacturersshouldconsiderwhendevelopingandimplementingacomplianceprogram….”第14页/共85页HHSOIGGuidelines(cont’d)EachOIGGuidanceisorganizedaround“sevenelementsthathavebeenwidelyrecognizedasfundamentaltoaneffectivecomplianceprogram.”These“sevenelements”are:ImplementingwrittenpoliciesandproceduresDesignatingacomplianceofficerandcommitteeConductingeffectivetrainingandeducationDevelopingeffectivelinesofcommunicationConductinginternalmonitoringandauditingEnforcingdisciplinarystandardsforwrongdoingRespondingpromptlytodetectprogramsandundertakingcorrectiveaction第15页/共85页HHSOIGGuidelines

PoliciesandProceduresWrittenpoliciesandproceduresshouldbedevelopedunderdirectionofComplianceOfficeranddistributedtoallrelevantemployeesPoliciesandproceduresshouldinclude:CodeofConduct:Ahigh-leveldocumentthatdetailsthefundamentalprinciples,values,andframeworkforactionwithinacompany.Itshouldbebrief,understandable,andcoverprinciplesapplicabletoallemployees.Detailedpoliciesinspecificriskareas:Thesepoliciesshouldaddressriskareasspecifictoacompany’sbusinessactivities,organizationalstructure,andregulatoryrequirements.

Whilepolicies–alone–donotconstituteaneffectiveprogram,muchofaneffectiveprogramflowsfromwrittenstandardsofconduct第16页/共85页HHSOIGGuidelines

ComplianceOfficerandCommitteeEverycompanyshoulddesignateahigh-levelofficialtoserveastheComplianceOfficer.Maybefull-orpart-time.ShouldhaveaccessandregularlyreporttotheBoardofDirectorsandSeniorManagement.Shouldhaveauthoritytoeffectuatechangewithintheorganization,toexerciseindependentjudgment,andtohaveaccesstoalldocumentsandinformationrelevanttocomplianceactivities.第17页/共85页HHSOIGGuidelines

ComplianceOfficerandCommitteeTheComplianceOfficer’sprimarydutiesshouldinclude:OverseeingimplementationofthecomplianceprogramReportingonregularbasistotheBoard,CEO,andothersPeriodicallyrevisingtheprogramtoaddresschangingneeds/activitiesImplementingamulti-facetededucationandtrainingprogramEnsuringthatindependentcontractorsareawareofthecompany’sprogramCoordinatingpersonnelissueswithHumanResourcesAssistingthecompany’sinternalauditorsincompliancereviewsReviewingandrespondingtoreportsofnon-complianceIndependentlyinvestigatingandactingonmattersrelatedtocomplianceParticipatingwithcounselinself-reportingtogovernmentagenciesContinuingthemomentumaftertheinitialyearsofimplementation第18页/共85页Johnson&Johnson

HealthCareComplianceFrameworkEachoperatingcompanymustbuildonthefoundationoftheJohnson&JohnsonHealthCareComplianceFrameworkandoperationalizeitbyimplementingdetailedpoliciesandprocedures.ArobustHealthCareComplianceprogramwillassisteachoperatingcompanyinfulfillingtheircommitmenttoresponsiblecorporateconduct.第19页/共85页Johnson&JohnsonHealthCareComplianceProgramFrameworkUSInternationalHealthCareComplianceGuidanceUSInternational第20页/共85页

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HealthcareComplianceFrameworkOperatingCompanies1.WrittenPoliciesandProcedures7.Responsetodetectedproblemsandcorrectiveactioninitiatives2.AssignedComplianceOfficer

&Committees6.Enforcement&DisciplinaryGuidelines5.Auditing&Monitoring3.Training4.CommunicationWWHealthCareComplianceOfficeLawDepartmentInternalAuditJohnson&JohnsonHealthCareComplianceCommonMission:Protectandgrowthebusiness.第21页/共85页Johnson&JohnsonHealthCareComplianceProgramWrittenPoliciesandProceduresFrameworkBasedonthe“SevenElementsofanEffectiveComplianceProgram”GuidanceUS-SafeHarborsandotherapplicablelaws/regulations/standardsInternational–GuidanceonkeyinteractionswithHealthCareProfessionals第22页/共85页Johnson&JohnsonHealthCareComplianceProgramAssignedComplianceOfficerandCommitteesChiefComplianceOfficerCorporateComplianceOfficerVPofWorldwideHealthCareComplianceHealthCareComplianceSteeringCommitteeHCCOfficerateachOperatingCompany–WorldwideHCCCommitteeateachOperatingCompany第23页/共85页BoardcommitteesAuditCommitteeManagementDevelopment&CompensationCorporateGovernanceScience&TechnologyComplianceGovernanceatGuidantLong-termCommitmenttoBoardBestPractices第24页/共85页GovernanceatGuidantLong-termCommitmenttoBoardBestPracticesJamesM.Cornelius

ChairmanoftheBoard

(non-executive)/

GuidantCorporation

Nancy-AnnMinDeParle

SeniorAdvisor/J.P.MorganPartners,LLC,AdjunctProfessor/TheWhartonSchool,UniversityofPennsylvania

RonaldW.Dollens

President,ChiefExecutive

Officer

J.KevinMoore

SeniorVicePresident,StrategicPlanning/AdvancedMedicalProductionsMarkNovitch,M.D.

RetiredViceChairman/TheUpjohnCompanyRuediE.Wäger,Ph.D.

President,ChiefExecutive

Officer/AventisBehringLLCComplianceCommitteeChairmanGuidantBoardComplianceCommitteeKristinaJohnson,PhDDepartmentChar.

SchoolofEngineeringDukeUniversity第25页/共85页GovernanceatGuidantCorporateControlsDiscipline

CorporateComplianceChiefComplianceOfficer(since1995)CCOreportsdirectlytotheCEOandtheComplianceCommitteeoftheBoardofDirectorsRobustauditandoversightQuarterlyupdatestoboardcommittee第26页/共85页

ComplianceCommitteeCharter GuidantComplianceCommitteeCharter

CodeofBusinessConductandCustomerRelationshipPolicies–overseeimplementationandfuturerevisionsProvideoversightfordevelopmentandimplementationofcomplianceprogramasaleaderintheindustryReviewstatusandsignificantcomplianceissuesPeriodicallyverifyleadingedgeofcomplianceprogramWithCEO,assessperformanceofcomplianceorganization/officeReviewmanagement/resourcecommitmenttocomplianceofficeCoordinatewiththeAuditCommitteeoncompliancemattersthatmaybesignificantfromafinancialperspective,andonmattersbroughttotheComplianceCommittee’sattentionrelatedtoauditingoraccountingissuesandcompliancewithrelatedlaws/regs

第27页/共85页HHSOIGGuidelines

EducationandTrainingCompaniesshouldimplementprogramstoeducateandtrainemployeesandagentsoncomplianceissues.Trainingshouldincludecommunicatingacompany’sstandardsofconducttoallrelevantemployeesandagents.Generaltrainingshouldfocusonthecompany’scomplianceprogram,writtenstandardsofconduct,andapplicableregulatoryrequirements.Specializedtrainingshouldbeprovidedtoemployeesandagentsinappropriateareas(e.g.,salesandmarketing,etc.)第28页/共85页HHSOIGGuidelines

EducationandTraining(cont’d)Newemployeesshouldreceivetrainingpromptly.TheComplianceOfficershoulddocumenttrainingprogramsandretainattendancelogs,descriptionsofthecomplianceprogram,andcopiesofmaterialsdistributed.Successfulcompletionoftrainingshouldbemadeaconditionofemploymentandadherencetotrainingrequirementsshouldbeafactorintheannualevaluationofeachemployee.第29页/共85页Johnson&JohnsonHealthCareComplianceProgramTrainingTestingandannualcertificationTargetedtojobresponsibilitiesNewEmployeeProgramTrainingonfailuretocomply第30页/共85页

CodeofBusinessConductTraining Selectedtopics第31页/共85页第32页/共85页第33页/共85页第34页/共85页第35页/共85页第36页/共85页第37页/共85页TRAININGTOOLS

On-lineTrainingManagementSystemIntegratedwithHRsystemMatchespeopleincurrentjobcategorytorequiredtrainingEmailmessagetotaketrainingFollow-upmessageto‘theboss’MaintainstherecordoftrainingtakenanddateAssessmenttestforunderstanding.Mustpasswith80%correct.

TrackingofTraining第38页/共85页HHSOIGGuidelines

InternalReporting&CommunicationsEmployeesshouldhaveaccesstoaccesstosupervisorsand/ortheComplianceOfficer.Companiesshouldimplementaninternal“hotline”orsimilarmechanismtoallowemployeesandotherstoaskquestionsorreportpotentialviolationsofpolicyorlaw.Reportingmechanismsshouldallowfortheanonymousreportingofviolationsandcompanypolicyshouldprohibitretaliationforgoodfaithreporting.Sarbanes-0xleyaddednewprohibitionsonretaliationinsomesituations第39页/共85页HHSOIGGuidelines

AuditingandMonitoringComplianceprogramsshouldincludemechanismstomonitorandauditcompliance.ComplianceOfficersshoulddocumenton-goingmonitoringandauditingprograms.Extentandfrequencyofcomplianceauditsmayvaryaccordingto:AvailableresourcesPriorhistoryofnon-complianceRiskfactorsparticulartothecompanyCanincludeprospectivesystemicrevieworaretrospectivereviewofactualpractices第40页/共85页Johnson&JohnsonHealthCareComplianceProgramAuditingandMonitoringSelfAssessments–webbasedtoolTestingMonitoringInternalAudits“Deepdives”Thirdpartyassessments第41页/共85页Johnson&JohnsonHealthCareComplianceProgramCommunicationsOpendoorpolicyHotlineInvestigationprotocolCasemanagementsystem“ToneatTop”第42页/共85页

GuidantReportingProcess:

YourSupervisororManagementGuidantLegalCounselHumanResourcesHelpline1-800-xxx-xxxxGUIDANTCOMPLIANCEOFFICEorINTERNALAUDIT

(allitems)

(certainitems)

InvestigationCorrectiveActionEMPLOYEE

IssuesReviewedbyAudit/ComplianceCommitteesFinancial/FraudIssues–AuditCommitteeAllissues–ComplianceCommittee

第43页/共85页

HELPLINECALLPRIORITIZATIONPriorityA

An“A”priorityreportinvolvesanemergencyorurgentsituation.Companyiscalled,reportdeliveredimmediately.PriorityB

Apriority“B”reportinvolvesaseriousortime-sensitiveissuethatdoesnotrisetothelevelofanemergency.Acompletedwrittenreportisdeliveredwithinafewhoursofthecall’scompletion.

PriorityC

A“C”priorityreportinvolvesroutinesortsofissuesthatarenottime-sensitiveanddonotrequireimmediateresponsebytheclient.Reportisdeliveredwithin24hours.第44页/共85页Guidant‘HelpLine’CallVolumebyType

第45页/共85页‘HelpLine’

Observations–SampleCumulativeStatistics

第46页/共85页

AllCallsinvestigated–alldocumentationofinvestigation,conclusionsandclosuredatemaintainedbycomplianceoffice

QuarterlyReviewwithEthicalIssuesReviewGroup(HR/Legal/FinancialAudit/Complianceseniormanagement)

EvaluateIssues Lookfortrends Identifycommunicationsneeded

BoardComplianceCommitteeReview

CurrentFollowupProcessandCommunication第47页/共85页HHSOIGGuidelines

EnforcementofDisciplinaryStandardsAneffectiveprogramshouldincludeclearandspecificdisciplinarypoliciesthatsetouttheconsequencesforviolationsofcompanypolicyorlaw.Companiesshouldadoptprocessestoensureconsistentenforcementofdisciplinarystandards.Disciplinaryactionalsomaybeappropriatewherearesponsibleemployee’sfailuretodetectaviolationisattributabletohisorhernegligenceorrecklessconduct.第48页/共85页HHSOIGGuidelines

RespondingtoDetectedOffensesUponreceiptofareasonableindicationofnon-compliance,theComplianceOfficerorothermanagementofficialshouldimmediatelyinvestigatetheallegation.Thereviewshouldbesufficientlydetailedtoidentifythe“rootcause”oftheproblem.Asappropriate,theinvestigationshould“includeacorrectiveactionplan,areportandrepaymenttothegovernment,and/orareferraltocriminaland/orcivillawenforcementauthorities.”Credibleevidenceofanadministrative,civilorcriminallawshouldbepromptlyreported(i.e.,within60days)toappropriatefederalandstateauthorities.第49页/共85页Johnson&JohnsonHealthCareComplianceProgramEnforcementandDisciplinaryActionDocumentedStandardsofconductDebarment/exclusionchecks第50页/共85页Johnson&JohnsonHealthCareComplianceProgramResponsetodetectedproblemsandactionstocorrectissuesManagementActionPlanHCCCommitteereviewprocess第51页/共85页RiskAssessmentUSSCrequirementforriskassessment:arequirementtoimplementanon-goingprocesstoassesstheriskofviolationsandtotakestepstoaddresssuchrisksGuidantExample第52页/共85页Risk=PotentialtoInterferewithAchievementofStrategyorBusinessObjectivesProcessGuidantwide,comprehensiveriskassessmentIdentifyPrioritizeQuantifyPlanCommunicate第53页/共85页RiskAssessmentProcessCross-functional/BUteamof11DomainExpertsand3VP’sSupportBestpracticesfromMarsh&McLennanGlobalCompliance,TreasuryandGC&R

第54页/共85页RiskSummitParticipantsEXECUTIVESPONSORSVPsrepresentingGlobalControl,Treasury,GlobalComplianceDOMAINEXPERTSDirectororManager

GC&RTreasurySOxCoreTeamGlobalCompliance,GSCLegalSalesISLegalManufacturingHRMarshRiskConsulting第55页/共85页BestPracticeProcessIdentifythe“vitalfew”businessriskstothecorporationAssessthestateofpreparednesstomanagethoserisksTakecorrectiveactiononprioritiesGainassurancethatconfidenceinthestateofpreparednessisjustifiedReporttheresultsandsustaintheprocessContinuouslyimprove第56页/共85页GuidantBusinessRiskInventory(BRI)CashFlowCollateralCommoditiesConcentrationCreditDefaultEquityFinancialInstrumentsForeignExchangeInterestRateLiquidityModelingOpportunityCostBusinessModelBusinessPortfolioImage/ReputationIntellectualPropertyProtectionLocationMarketIntelligenceOrganizationalStructurePlanningProductRelevanceResourceAllocationCapitalAvailabilityDistributionInfrastructureIndustry

RegulatoryEnvironment

PoliticalCompetitorEconomyLegalShareholderRelationsTerrorismCustomerNeedsFinancialMarketsNaturalHazardSocialResponsibilityStrategicOperationalFinancialManagementInformationBudgeting&ForecastingCompleteness/AccuracyFinancialReportingInvestmentEvaluationPensionFundTaxationIntegrityTechnologyAccessAvailabilityCapacity/InfrastructureDataIntegrityE-CommerceInformationSecurityInfrastructureRelevanceReliabilityTechnologicalInnovationAcquisitionIntegrationDistributionMeasurementRealEstateBusinessInterruptionEfficiencyPartneringRelationshipMgmtChangeResponseSalesPracticesPatentInfringement(vendor/customer)Compliance/Reg.RptEnvironmentalPhysicalSecuritySourcingContractCommitmentHealthandSafetyProductSvcLiabilitySupplyChainCustomerSatisfactionInventoryMgmt

Product/SvcFailureStrategyImplementationCycleTimeKnowledgeMgmtProduct/SvcPricingTransactionProcessingDeliveryChannelMfg.CapacityProjectExecutionProductDevelopmentProcessHumanCapitalAccountabilityChangeReadinessCommunications(Internal)Competencies/SkillsCulturalShiftCultureEmployeeConcentrationEmploymentLawPracticesEmploymentLawViolationEmpowermentHiring/RetentionEpidemic/PandemicExposureLeadershipPerformanceIncentivesSuccessionPlanningTemporaryWorkforceTraining/DevelopmentWorkplaceViolenceINTERNALRISKSEXTERNALRISKSProcessConflictofInterestEmployeeFraudEthicalDecisionMakingIllegalEmployeeActsManagementFraud3rdPartyFraudUnauthorizedActs第57页/共85页GuidantKeyBRIBusinessPortfolioIntellectualPropertyProductRelevanceCompetitor RegulatoryEnvironmentShareholderRelations Political Industry NaturalHazard

StrategicOperationalFinancialManagementInformationFinancialReportingIntegrityTechnologyDataIntegrityInformationSecurityReliabilityCompliance/RegulatoryReportingInventoryManagementKnowledgeManagementManufacturingCapacityProductDevelopmentProcessHumanResourceCompetencies/SkillsCulturalShiftCultureEmploymentLawPracticesHiring/RetentionSuccessionPlanningTraining/DevelopmentINTERNALRISKSEXTERNALRISKSProcessConflictofInterestIllegalEmployeeActsProduct/ServiceFailureSalesPracticesSourcing第58页/共85页RiskAssessmentPrioritiesKeyBusinessPortfolioCompetitorCultureNaturalHazardProductDevelopmentProcessPolitical4第59页/共85页

RiskManagementProcess

TreasuryBCP/InsuranceResponseRiskManagementProcess GlobalControl&Reengineering

GuidantWideComplianceCoverage第60页/共85页

RiskManagementSummary

Regulatory

Environment

StrategicandFinancialGMCExternalGMCOperationalBU’s/HQ

第61页/共85页PracticalConsiderationsEventhemostimpressivewrittencomplianceprogramsmaydolittletopreventanddetectviolationsoflaw.Effectiveprogramsaredynamic,enjoythesupportofseniormanagement,andaretailoredtoacompany’sculture,organization,andactivities.Numerousagenciesareinvolvedintheinvestigativeandenforcementprocess,andeachhasvaryingstandardsandexpectationswithrespecttocomplianceprograms.Governmentinvestigatorsandprosecutorsareknowledgeableaboutcomplianceprograms–paperprogramswillnothaveaninfluenceontheirdecisionmaking.第62页/共85页第63页/共85页ENDOFPRESENTATIONONE第64页/共85页HealthCareComplianceProgram第65页/共85页第66页/共85页InternationalHealthCareComplianceProgram第67页/共85页2004Salesof$47.3BillionOver200operatingcompaniesin57countriesaroundtheworldLeadershippositionsinethicalandOTCpharmaceuticals,medical/surgicalsupplies,diagnosticsandavarietyofconsumerproductsBroadbased,diverseportfolioofproducts

World’sMostComprehensiveandBroadlyBasedHealthCareCompany第68页/共85页ByGeographicAreaWorldwideNetTradeSales2004U.S.EuropeW.Hem(ex.US)AsiaPacific&Africa12%5%24%59%$47.3Billion第69页/共85页TheGlobalHealthCare

EnvironmentOperatingCompaniesForeignCorruptPracticesActUSLaws&RegulationsCountryLawsandRegulationsCountryStandards第70页/共85页Johnson&JohnsonHealthCareComplianceProgram-InternationalElementsPolicyonBusinessConduct-GlobalInternationalHealthCareComplianceFrameworkInternationalHealthCareComplianceGuidanceLocallaws,regulationsandindustrystandardsFCPAtrainingConsistentapproachglobally第71页/共85页InternationalProgramRoll-OutQ12005Q22005Q32005Q42005LawDept.FinalizeGuidesCOHCC&LawDept.FinalizeFrameworkApprovedImplementationPlanCommunicationPlanTrainingCoreBestPracticesDevelopedDevelop&Roll-outSelf-AssessmentMAARSTrainingStaffHCCCoordinatew/LawDept.onneedforidentificationoflocalcounselImplementFrameworkincludingorganizationalredesignOpCoProcess&DocumentDevelopmentEmployeeTrainingTesting&MonitoringCompleteSelf-AssessmentOpCow/GuidancefromLawDept&COHCC第72页/共85页InternationalHCCGuideObjective: setofcommon-required-standards forinteractionswithHCP ifmorerestrictive,locallaws, reg