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 2a: Signal Detection in Clinical Development10:45 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 2b: Signal Detection in Clinical Development (continued)12:30 PM — 1:30 PM
1:30 PM — 2:00 PM
Session 3: Confounding and Bias2:00 PM — 2:30 PM
Session 4: Causaltiy Assessment2:30 PM — 3:00 PM
Session 5: Program Safety Analysis Plan3:00 PM — 3:15 PM
3:15 PM — 5:00 PM
Session 6: Post-Marketing Signal Detection5:00 PM — 5:15 PM
Questions and Answers / Wrap-Up8:15 AM — 8:45 AM
8:45 AM — 10:45 AM
Session 6: Post-Marketing Signal Detection (Continued)10:45 AM — 11:00 AM
11:00 AM — 12:00 PM
Session 7: Disproportionality Algorithm Performance12:00 PM — 12:30 PM
Disproportionality Analysis System Demonstration12:30 PM — 1:30 PM
1:30 PM — 2:30 PM
Session 8: Signal Management System2:30 PM — 3:15 PM
Session 9: Benefit-Risk Assessment3:15 PM — 3:30 PM
3:30 PM — 4:00 PM
Session 10: Future Directions in Signal Detection4:00 PM — 4:30 PM
Questions and Answers, Wrap-Up, and Course Adjournment