アジェンダ
7:30 AM — 5:00 PM
10:00 AM — 5:00 PM
Short Course 1: Pharmacovigilance and Risk Management Planning1:30 PM — 5:00 PM
Short Course 4: FDA Pharmacovigilance Inspection Readiness7:30 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Opening Remarks10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 2: FDA Updates12:00 PM — 1:30 PM
12:00 PM — 12:30 PM
Round Table Luncheon Discussions1:30 PM — 3:00 PM
Session 3: Changing Environments3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4: Safety Data rEvolution5:00 PM — 5:15 PM
5:15 PM — 6:45 PM
Session 5: Integrated Adaptive Development and Decision Making7:30 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Opening Remarks - Day 28:45 AM — 10:15 AM
Session 6: EU Regulatory Updates10:15 AM — 11:00 AM
11:00 AM — 12:00 PM
Session 7: Globalization of the Responsible Person12:00 PM — 1:30 PM
12:00 PM — 12:30 PM
Round Table Luncheon Discussions1:30 PM — 3:00 PM
Session 8: Advances in Benefit-Risk3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 9: Engaging the Customer - Health Care Providers5:00 PM — 6:00 PM
7:15 AM — 8:15 AM
8:15 AM — 8:30 AM
Welcome and Opening Remarks Day 38:30 AM — 10:00 AM
Session 10: Advanced Therapies10:00 AM — 10:30 AM
10:30 AM — 12:00 PM
Session 11: Advanced Technologies12:00 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 12: Hot Topic Panel3:00 PM — 3:15 PM