借助 Amazon Bedrock Agentcore 加速生命科学监管情报.pdf

1、I N D 4 1 4Accelerating life sciences regulatory intelligence with Amazon Bedrock AgentCoreChandra Parvathaneni(he/him)Global Partner Solutions ArchitectAWSRishi Sharma(he/him)Sr.Solutions ArchitectAWS 2025,Amazon Web Services,Inc.or its affiliates.All rights reserved.AgendaIntroduction:Regulatory c

2、hallenges in pharmaTechnical deep dive:Agentic AI on AWSSecurity,Identity and ComplianceResponsible AI&governance frameworkImplementation best practices Q&A 2025,Amazon Web Services,Inc.or its affiliates.All rights reserved.Introduction to pharma regulatory complianceConsumersUSA(FDA)Canada(Health C

3、anada)India(CDSCO)Japan(PMDA)Italy(AIFA)France(ANSM)Regulatory agenciesCategoriesNationalRegionalGlobalEMA European Medicines AgencyAMRH African Medicines Regulatory HarmonizationsWHO World Health OrganizationICH International Council for HarmonizationPharmaceuticals regulationsQuality,safety&effica

4、cyMedical Products&TechnologyHealth Systems&ServicesClinical trails Laboratory quality standardsRegulatory submission standardsAdverse event reporting frameworkHealth Information&DataFood Safety&NutritionFood safety standardsNutritional labeling,additives and contaminationManufacturing and developme

5、nt companiesHealthcare providers and distributorsRegulatory and quality professionalsSupply chain partnersGovernment and oversight bodiesFinancial and business stakeholders 2025,Amazon Web Services,Inc.or its affiliates.All rights reserved.Regulatory hurdles in pharmaGood manufacturing practice (GMP

6、)complianceComplex multi-jurisdictional requirementsClinical trails regulationsData integrity and documentationPharmacovigilance and post-market surveillanceFinancial burdenTime-to-market delaysRisk of enforcement actionsOperational complexityStrategic constraintsPharma must adapt as regulations con