Agenda
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
8:45 AM — 9:45 AM
Session 1: INTRODUCTION TO BENEFIT/RISK METHODOLOGY10:15 AM — 10:45 AM
10:45 AM — 11:15 AM
Session 3: INTRODUCTION TO BENEFIT/RISK MANAGEMENT11:15 AM — 12:15 PM
Session 4: SAFETY SPECIFICATION12:15 PM — 1:15 PM
1:15 PM — 1:45 PM
Session 5: EFFICACY AND EFFECTIVENESS SPECIFICATION1:45 PM — 2:00 PM
Session 6: DOS AND DON’TS IN SAFETY AND EFFICACY SPECIFICATIONS2:00 PM — 2:45 PM
Session 7: PHARMACOVIGILANCE PLAN2:45 PM — 3:15 PM
3:15 PM — 4:00 PM
Session 8: EFFICACY FOLLOW-UP PLAN4:00 PM — 5:00 PM
Session 9: RISK MITIGATION5:00 PM — 6:00 PM
8:20 AM — 8:40 AM
Session 10: BENEFIT OPTIMISATION8:45 AM — 9:45 AM
Session 12: BENEFIT/RISK MANAGEMENT PLAN - CASE STUDIES9:45 AM — 10:15 AM
10:15 AM — 11:00 AM
Session 12 continued: BENEFIT/RISK MANAGEMENT PLAN - CASE STUDIES11:00 AM — 11:45 AM
Session 13: USE OF BENEFIT/RISK MANAGEMENT PLANS IN REGULATORY SUBMISSIONS11:45 AM — 12:15 PM
Session 14: BENEFIT/RISK COMMUNICATION12:15 PM — 1:15 PM
1:15 PM — 2:15 PM
Session 15: USE OF BENEFIT/RISK MANAGEMENT PLANS IN CRISIS MANAGEMENT2:15 PM — 3:15 PM
Session 16: EXERCISE - CRISIS MANAGEMENT3:15 PM — 3:45 PM
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