Past Event
Date
April 18-20, 2024
Location
Zhaolin Grand Hotel, Beijing
Booth 1
The 5th Annual Regulation – Biostatistics Conference
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Biostatistics and Programming
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Protocol Development, including clinical trial design, sample size calculations, SAP summaries
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SAP, TFLs, dataset and data transfer
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Study Monitoring, including DSMB, Interim Analyses
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Data Analysis, including CDISC SDTM, ADaM, and SEND dataset programming
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Pooling strategy for ISS/ISE, CDISC define.xml and other e-submission components
Real World Data Solutions
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Quantify Opportunity: Unmet needs, treatment patterns, burden of illness, market sizing
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Justify Access: Cost minimization, cost offsets, cost effectiveness and budget impact analysis, patient/caregiver/societal perspectives
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Measure Performance: Drug utilization studies, relative effectiveness, outcomes performance, Post-authorisation efficacy study (PAES)
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Ensure Safety: Benefit/risk assessment, risk management, signal detection, Post-Authorization Safety Studies (PASS)