CDISC Interchange2023presentation·US·Session 6B: CDISC Foundational, Part IIADaM implementation of Anti-drug Antibody (ADA) Analysis Dataset CDISC-F207585C North AmericaSee metadata
CDISC Interchange2023presentation·US·Session 6C: CORE WorkshopCORE Workshop CDISC-E7FEE012 North AmericaSee metadata
CDISC Interchange2023presentation·Japan·Session 7: Global Regulatory SubmissionsOur Guide On Creating A Successful BIMO Data Package CDISC-6A503532 Asia-PacificSee metadata
CDISC Interchange2023presentation·Japan·Session 7: Global Regulatory SubmissionsUsing R to Generate Analysis Results Metadata (ARM) CDISC-9E3232ED Asia-PacificSee metadata
CDISC Interchange2023presentation·Japan·Session 7: Global Regulatory SubmissionsUnlocking the Potential: Exploring Overlooked FDA Guidance for CDISC Implementers CDISC-A4060BA2 Asia-PacificSee metadata
CDISC Interchange2023presentation·Korea·Session 7: Regulatory & Academic TopicsStreamlining Academic Research Through Meta-Analysis Enhanced by CDISC Standards Integration CDISC-753F2DB1 Asia-PacificSee metadata
CDISC Interchange2023presentation·Korea·Session 7: Regulatory & Academic TopicsSEND, The Need for the Implementation of the 3Rs Principles in Animal Tests CDISC-CF609FA4 Asia-PacificSee metadata
CDISC Interchange2023presentation·Korea·Session 7: Regulatory & Academic TopicsEvaluating Safety, Quality and Traceability of Regulatory Submission Data CDISC-D4590DBD Asia-PacificSee metadata
CDISC Interchange2023presentation·US·Session 7: Third Plenary - Regulatory PresentationsPMDA Presentation CDISC-8E1E927D North AmericaSee metadata
CDISC Interchange2023presentation·US·Session 7: Third Plenary - Regulatory PresentationsFDA Presentation on Technical Conformance Guide (TCG) CDISC-1580BFDC North AmericaSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track A- Regulatory Topics, Part IIPDUFAVII Updates: Data and Statistical Considerations when Submitting Analysis Data for DHT-Derived Endpoints CDISC-9C435361 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track A- Regulatory Topics, Part IIAdvancing Premarket Safety Analytics CDISC-36903BA3 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track B- Digital Data FlowProtocol Optimization with DDF CDISC-71B1DE7B EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track B- Digital Data FlowCDISCs Activities on DDF, Benefits for the Community and Looking Ahead CDISC-5347AB3A EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track B- Digital Data FlowUsing DDF to Drive Clinical Data Automation CDISC-6894A9C3 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track B- Digital Data FlowAutomating the Digital Data Flow with a Standards Foundation CDISC-CBC6876C EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track C- CDISC Foundational, Part IIInfant Safety Data (Associated Persons data) Collection in HIV Study CDISC-1CF59741 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track C- CDISC Foundational, Part IIDHT Data Standard Subteam: A Path to Data Standardization of DHTs CDISC-A4C560A9 EuropeSee metadata
CDISC Interchange2023presentation·Europe·Session 7: Track C- CDISC Foundational, Part IILessons Learned with the SENDIG-DART FDA Fit-For-Use Pilot CDISC-F125F9D0 EuropeSee metadata
CDISC Interchange2023presentation·China·Session 7A: ConformanceIssue Management in P21E CDISC-73AD38ED ChinaSee metadata