Agendas
9:00 AM — 12:00 PM
Tutorial 1: Statisticians as Leaders1:30 PM — 4:30 PM
Tutorial 3: Subgroup Analysis in Clinical Trials1:30 PM — 4:30 PM
Tutorial 4: Dose Finding in Drug Development: Methods and Implementation7:30 AM — 8:45 AM
8:30 AM — 8:45 AM
Welcome and Opening Remarks8:45 AM — 9:15 AM
FDA Update9:15 AM — 9:50 AM
Keynote Address9:50 AM — 10:30 AM
Keynote Address10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 1: Statistical Issues in Biosimilar Analytical Assessment12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 2: Observational Studies and Beyond3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 3: Estimands and Sensitivity Analyses7:30 AM — 8:30 AM
10:00 AM — 10:30 AM
12:00 PM — 1:30 PM
Luncheon and Roundtable Discussions1:30 PM — 3:00 PM
Session 6: Subgroup Analysis3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 7: Quantitative Measures for Benefit-Risk Assessment5:00 PM — 7:00 PM
Networking Reception and Poster Session7:30 AM — 8:30 AM
10:00 AM — 10:15 AM
12:00 PM — 1:00 PM
1:00 PM — 2:30 PM
Session 10: Adaptive Design and Bayesian Working Group Feedback2:30 PM — 3:00 PM
3:00 PM — 4:30 PM
Session 11: FDA and Industry Town Hall4:30 PM — 4:30 PM
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