Agenda
8:30 AM — 12:00 PM
Tutorial #1 – Pharmacovigilance and Risk Management Planning1:30 PM — 5:00 PM
Tutorial #4 – Pharmacovigilance System Master File8:30 AM — 8:45 AM
Welcome and Opening Remarks8:45 AM — 10:00 AM
Session 1 - Keynote Presentation10:30 AM — 12:00 PM
Session 2 - FDA Updates1:30 PM — 3:00 PM
Session 3 - Drug Safety in China - The Importance of What's Happening3:30 PM — 5:00 PM
Session 4 - Emerging Markets8:30 AM — 10:00 AM
Session 5 – EU Regulations – Regulatory Overview10:30 AM — 12:00 PM
Session 6 – Harmonization1:30 PM — 3:00 PM
Session 7 – Benefit-Risk and Risk Management3:30 PM — 5:00 PM
Session 8 – Patient Perspective8:30 AM — 10:00 AM
Session 9, Part I – Real World Evidence: The Building Blocks10:30 AM — 12:00 PM
Session 9, Part II – Real World Evidence: Safety Applications1:30 PM — 3:00 PM
Session10 – Social MediaHave an account?