Agendas
10:00 AM — 5:00 PM
Pharmacovigilance and Risk Management Planning1:30 PM — 5:00 PM
Pharmacovigilance System Master File1:30 PM — 5:00 PM
PBRERs7:30 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Opening Remarks8:45 AM — 10:00 AM
Session 1 - Keynote Address10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 2 – FDA Updates12:00 PM — 1:30 PM
Roundtable Lunch Discussions1:30 PM — 3:00 PM
Session 3 – Asia Regulatory Updates3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4 – Maturing Markets Perspective5:00 PM — 6:00 PM
7:30 AM — 8:30 AM
8:30 AM — 10:00 AM
Session 5 – EU Regulatory Updates10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 6 - Regional Requirements with Global Impact: The Drivers for Change12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 7 – Risk Management Planning3:00 PM — 3:30 PM
7:30 AM — 8:30 AM
10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 10 – Real World Evidence – A True Snapshot of Benefit and Risk12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 11 - Stakeholder Perspectives on Communicating Risk3:00 PM — 3:00 PM
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