アジェンダ
10:00 AM — 10:15 AM
Welcome and Introduction10:15 AM — 11:00 AM
Session 1: Signal Detection Fundamentals11:00 AM — 11:45 AM
Session 2: Signal Detection in Clinical Development11:45 AM — 12:00 PM
12:00 PM — 1:45 PM
Session 2: Signal Detection in Clinical Development (continued)1:45 PM — 2:00 PM
Questions and Answers10:00 AM — 10:15 AM
Review of Day 110:15 AM — 11:30 AM
Session 3: Open-Source Visualization Tools11:30 AM — 12:00 PM
Session 4: Confounding and Bias12:00 PM — 12:15 PM
12:15 PM — 1:15 PM
Session 5: Causality Assessment1:15 PM — 1:45 PM
Session 6: Aggregate Safety Analysis Plan1:45 PM — 2:00 PM
Questions and Answers10:00 AM — 10:15 AM
Review of Day 210:15 AM — 12:15 PM
Session 7: Post-Marketing Signal Detection12:15 PM — 12:30 PM
12:30 PM — 1:15 PM
Session 8: Disproportionality Algorithm Performance1:15 PM — 2:00 PM
Session 9: Disproportionality Analysis System2:00 PM — 2:15 PM
Questions and Answers10:00 AM — 10:15 AM
Review of Day 310:15 AM — 12:15 PM
Session 10: Signal Management Systems12:15 PM — 12:30 PM
12:30 PM — 1:15 PM
Session 11: Benefit-Risk Assessment1:15 PM — 2:00 PM
Session 12: Future Directions in Signal Detection2:00 PM — 2:15 PM
Session 13: Summary2:15 PM — 2:30 PM
Questions and Answers and Wrap-Up