アジェンダ
8:15 AM — 8:45 AM
8:45 AM — 9:00 AM
Welcome and Introduction9:00 AM — 9:45 AM
Session 1: Signal Detection Fundamentals9:45 AM — 10:45 AM
Session 2: Signal Detection in Clinical Development10:45 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 2: Signal Detection in Clinical Development (continued)12:30 PM — 1:30 PM
1:30 PM — 2:30 PM
Session 3: Signal Evaluation Exercise - Using the Hepatic Explorer2:30 PM — 3:30 PM
Session 4: Confounding and Biaas3:30 PM — 3:45 PM
3:45 PM — 4:15 PM
Session 5: Signal Evaluation - Causality Assessment4:15 PM — 4:45 PM
Session 6: Aggregate Safety Analysis Plan4:45 PM — 5:00 PM
Q&A / Wrap-up8:15 AM — 8:45 AM
8:45 AM — 10:45 AM
Session 7: Post-Marketing Signal Detection10:45 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 7: Post-Marketing Signal Detection (Continued)12:30 PM — 1:15 PM
1:15 PM — 2:15 PM
Session 8: Disproportionality Algorithm Performance2:15 PM — 2:45 PM
Session 9: Disproportionality Analysis System2:45 PM — 3:00 PM
3:00 PM — 3:45 PM
Session 10: Signal Management System3:45 PM — 4:15 PM
Session 11: Benefit-Risk Assessment4:15 PM — 4:45 PM
Session 12: Future Directions in Signal Detection4:45 PM — 5:00 PM
Q&A, Wrap-Up, and Course Adjournment