CDISC Interchange2026presentation·Europe·Session 5, Track E: TMF Standards and Governance - Allegoria del Buon GovernoeClinical Systems Has Entered the Chat: The TMF Zone We've Been Waiting For 5E.1 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 5, Track E: TMF Standards and Governance - Allegoria del Buon GovernoShaping Zone 10 for Tomorrow’s Data Governance: A Collaborative Approach to TMF Standard v1.0 5E.2 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 5, Track E: TMF Standards and Governance - Allegoria del Buon GovernoFrom Standards to Strategy: Customizing CDISC Open Rules for TMF Reference Model 5E.3 EuropeSee metadata
CDISC Interchange2026presentation·China·Session 5: RegulatoryShaping the Future of Regulatory Data in the AI Era – An EMA Perspective 5.1 ChinaSee metadata
CDISC Interchange2026presentation·China·Session 5: RegulatoryMulti-Regional Data Submission/AI Implementation 多地区数据递交/人工智能应用 5.2 ChinaSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track A: Standards AccelerazioneFrom Data Traceability to Evidence Traceability: A Provenance Layer for CDISC Standards in Metadata-Driven SCEs 6A.1 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track A: Standards AccelerazioneUsing Open-Source Tools to Drive Standards-Based Automation: From SDTM Setup to CDISC-Compliant Submission 6A.2 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track A: Standards AccelerazioneBuy One – Get Three! Rule-Based Naming and Standardization of SoA, SDTM, and ADaM Metadata 6A.3 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track B: ADaM ImplementazioneMighty Metadata: YAML-Powered ADaM Specifications 6B.1 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track B: ADaM ImplementazioneConnecting the Dots: Future of Estimand Implementation 6B.2 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track B: ADaM ImplementazioneThe Chicken, the Egg, and the ADaM: Cracking the PRE-ADSL vs ADSL Sequence 6B.3 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track C: L'Architettura degli StandardBuilding a Library of Instantiated Biomedical Concepts to Ensure Consistency and Reusability in Study Designs 6C.1 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track C: L'Architettura degli StandardSchema-First Metadata Engineering: A Missing Structural Layer for Reliable Standards and Automation 6C.2 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track C: L'Architettura degli StandardAuthenticity Matters: Preserving Standards Integrity from Clinical Data Models to Tiramisù 6C.3 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track D: Impact of Regulations - Vi Offriremo Regole Che Non Potrete RifiutareImpact of EU CTR on Trial Master File (TMF) Record Management 6D.1 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track D: Impact of Regulations - Vi Offriremo Regole Che Non Potrete RifiutareFrom Essential Documents to Essential Records: Building ICH E6(R3) into the Future CDISC TMF Standard Model 6D.2 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track D: Impact of Regulations - Vi Offriremo Regole Che Non Potrete RifiutareStrengthening eTMF Security for Cross Border Clinical Data Protection & Data Re-use: GSK’s Model Aligned with CISA and ICH Guidance 6D.3 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track E: Interoperability - Start, During and End - Rinascimento Digitale a Tutto TondoTMF Interoperability: The Critical Importance of Standard Integrations of Clinical Trial Management Data to Promote eTMF Health and Completeness 6E.1 EuropeSee metadata
CDISC Interchange2026presentation·Europe·Session 6, Track E: Interoperability - Start, During and End - Rinascimento Digitale a Tutto TondoBeyond the Repository: Harmonising TMF Ecosystems through Interoperability and Data Flow 6E.2 EuropeSee metadata
CDISC Interchange2026presentation·China·Session 6: CDISC Open Source UsageCDISC CORE 6.1 ChinaSee metadata