Agenda
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
8:45 AM — 10:30 AM
SESSION 1 INTRODUCTION TO BENEFIT/RISK MANAGEMENT10:45 AM — 11:15 AM
11:00 AM — 11:45 AM
SESSION 2 INTRODUCTION TO BENEFIT/RISK METHODOLOGIES11:45 AM — 12:15 PM
SESSION 3 SAFETY SPECIFICATION12:15 PM — 1:15 PM
1:15 PM — 1:45 PM
SESSION 4 MODES AND EFFECTS ANALYSIS1:45 PM — 2:00 PM
SESSION 5 DOS AND DON’TS IN SAFETY AND EFFICACY SPECIFICATIONS2:00 PM — 2:45 PM
SESSION 6 PHARMACOVIGILANCE PLAN2:45 PM — 3:15 PM
3:15 PM — 4:00 PM
SESSION 7 EFFICACY SPECIFICATION AND FOLLOW-UP PLAN4:00 PM — 5:00 PM
SESSION 8 RISK MITIGATION8:20 AM — 8:40 AM
SESSION 9 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 CONTINUED11:00 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 SESSIONHave an account?