RAPS Convergence 2025
In-Person David L. Lawrence Convention Center
1000 Fort Duquesne Blvd
Pittsburgh, Pennsylvania, USA, 15222-3622
510(k)AdvancedAdvanced manufacturingAdvanced therapies/cell and gene therapyAdverse eventsAdvisory committeesAfricaAntimicrobial resistanceAPIsApproval/marketing authorizationArtificial intelligence/machine learning (AI/ML)AsiaAustrian Agendy for Health and Food Safety (AGES)Biologics License Application (BLA)Biologics/ biosimilars/ vaccinesBiotechnologyBreakthrough devices programBsUFACanadaCAPACareer developmentCBERCDERCDRHCE MarkClinical outcome assessmentClinical Trials Regulation Combination productsCombination products/companion diagnosticsCompanion diagnostics (CDx)CompoundingConformity AssessmentContaminantsContinuous manufacturingCoronavirus/COVID-19CosmeticsCTD/eCTDCybersecurityDe novoDecentralized clinical trialsDiagnostics/IVDsDigital health/SaMD/AIDrug master file (DMF)DSCSAEnforcementEthics/Professional ConductEUDAMEDEuropean Medicines Agency (EMA)Expanded access/Right to Try/Compassionate useExpedited pathwaysExpertFinal ruleFoundationalGDUFAGenericsGlobalGMPGuidanceHealth technology assessment (HTA)Human cells, tissues, and cellular and tissue-based products (HCT/Ps)Human factorsIn Vitro Diagnostic Medical Devices Regulation (IVDR)IntermediateLatin America/CaribbeanLeadershipMedical DevicesMiddle EastModeling and simulationNorth AmericaNutritional/Natural HealthOceaniaOTCOtherPediatric productsPerformance evaluationPharmaceuticalsPIC/SPostmarketing clinical follow up (PMCF)Postmarketing requirement/postmarketing commitmentPreclinicalPremarket approval (PMA)Priority review voucherProposed rulePRRCPublic healthQMSRQuality management system/QMSRecallsRegulatory harmonizationRegulatory strategyReimbursementRemote interactive evaluationREMSRWE/RWDShortagesSoftware bill of materials (SBOM)StandardsSterile drugsSubmission and registrationSwissmedicTechnical documentationTherapeutic Goods AdministrationUDI/UDI-DIUnited StatesUS Food and Drug Administration (FDA)User feesWarning lettersWHO