アジェンダ
10:00 AM — 5:00 PM
Tutorial #1 - Pharmacovigilance and Risk Management Planning7:30 AM — 6:00 PM
7:30 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
Luncheon in Exhibit Hall and Round Table Discussions1:30 PM — 3:00 PM
Session 3 – Maturing Markets Regulatory Updates3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4 – New Data Sources5:00 PM — 6:00 PM
#PVRMS16 Tweetup5:00 PM — 6:00 PM
7:00 AM — 1:30 PM
Tutorial #3 – Periodic Benefit-Risk Evaluation Report (PBRER)7:00 AM — 1:30 PM
Tutorial #4 – Principles and Practice of Pharmacovigilance Governance7:30 AM — 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 – Blinding/Unblinding12:00 PM — 1:30 PM
Luncheon in Exhibit Hall and Round Table Discussions1:30 PM — 3:00 PM
Session 7 – Benefit-Risk3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 8 – Customer Engagement Programs7:30 AM — 3:00 PM
7:30 AM — 8:30 AM
8:30 AM — 10:00 AM
Session 9 – Biosimilars10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 10 – Advanced Therapies12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 11 – HOT TOPIC PANEL: Earlier Access vs. Additional Safety?3:00 PM — 3:00 PM