Agenda
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
8:45 AM — 10:30 AM
SESSION 01: INTRODUCTION TO BENEFIT/RISK MANAGEMENT10:30 AM — 11:00 AM
11:00 AM — 11:45 AM
SESSION 02: INTRODUCTION TO BENEFIT/RISK METHODOLOGIES11:45 AM — 12:15 PM
SESSION 03: SAFETY SPECIFICATION12:15 PM — 1:15 PM
1:15 PM — 1:45 PM
SESSION 04: FAILURE MODES AND EFFECTS ANALYSIS1:45 PM — 2:00 PM
SESSION 05: DOS AND DON’TS IN SAFETY SPECIFICATION2:00 PM — 2:45 PM
SESSION 06: PHARMACOVIGILANCE PLAN2:45 PM — 3:15 PM
3:15 PM — 4:00 PM
SESSION 07: EFFICACY SPECIFICATION AND FOLLOW-UP PLAN4:00 PM — 5:00 PM
SESSION 08: RISK MITIGATION5:00 PM — 6:00 PM
8:20 AM — 8:45 AM
SESSION 09: BENEFIT OPTIMISATION8:45 AM — 9:45 AM
SESSION 10: BENEFIT/RISK MANAGEMENT PLAN - CASE STUDIES9:45 AM — 10:15 AM
10:15 AM — 11:00 AM
SESSION 10 CONTINUED: BENEFIT/RISK MANAGEMENT PLAN - CASE STUDIES11:00 AM — 12:15 PM
SESSION 11: USE OF BENEFIT/RISK MANAGEMENT PLANS IN REGULATORY SUBMISSIONS12:15 PM — 1:15 PM
1:15 PM — 2:15 PM
SESSION 12: BENEFIT/RISK COMMUNICATION2:15 PM — 3:15 PM
SESSION 13: INTERACTIVE SESSION¿Tiene una cuenta?