强生制药公司病人管理规范营销.pptxVIP

The Pharma, Biotech and Device ColloquiumCompliance Pre-Conference WorkshopMonday, June 6, 2005A Primer on Compliance Programs for Pharmaceutical and Medical Device CompaniesLouise MehrotraVP WW Health Care ComplianceJohnson Johnson Kathy LundbergSVP/Chief Compliance OfficerGuidant CorporationWorld’s Most Comprehensive and Broadly Based Health Care Company2004 Sales of $47.3 BillionOver 200 operating companies in 57 countries around the worldLeadership positions in ethical and OTC pharmaceuticals, medical/surgical supplies, diagnostics and a variety of consumer productsBroad based, diverse portfolio of productsWorldwide Net Trade SalesBy Geographic Area200424%59%5%12%U.S.$47.3 BillionW. Hem (ex. US)Asia Pacific AfricaEuropeSales by SegmentMDD$16.9 BillionConsumer$8.3 Billion35.7%17.6%46.7%Pharmaceutical$22.1 Billion2004Guidant Corporate ProfileIndiana-based company selling products in 100 countries around the worldLeader in design and manufacture of cardiac and vascular devices and therapiesBusiness units with up to 30 years experience in key marketsOver 12,000 employees worldwideGDT traded on the NYSE and PCXGeographic OperationsVIESCSCRMVASCULAR INTERVENTIONENDOVASCULARSOLUTIONSCARDIACSURGERYCARDIAC RHYTHMMANAGEMENTCOMPASSHeadquartersGuidant Corporation StructureOverviewWhy are Compliance Programs Important?History and Basics of the U.S. Sentencing Commission GuidelinesHHS OIG Compliance Program GuidelinesCompliance Program BasicsWritten Standards of ConductLeadership and InfrastructureEducation and TrainingInternal Communications and ReportingMonitoring and AuditingEnforcement of Disciplinary StandardsResponding to Detected OffensesConcluding ThoughtsWhy Are Compliance Programs Important? (Or … Who Cares?)Effective programs can prevent wrongdoing and lessen the damage when violations do occur.A credible compliance program can be influential at key stages of the investigative and enforcement processes:Whether to continue or expand an investigationWhether to tu