アジェンダ
10:00 AM — 10:30 AM
Welcome and Introductions10:30 AM — 11:10 AM
Session 1: Course Overview11:10 AM — 11:55 AM
Session 2: What is Risk Management?11:55 AM — 12:15 PM
12:15 PM — 1:15 PM
Session 3: Global Risk Management Guidelines and Regulations1:15 PM — 2:00 PM
Session 4: Activity2:00 PM — 2:15 PM
Question & Answer10:00 AM — 10:15 AM
Review of Day 110:15 AM — 11:15 AM
Session 5: Content of a US Risk Evaluation & Mitigation Strategy (REMS)11:15 AM — 12:30 PM
Session 6: Content of an EU Risk Management Plan (EU-RMP)12:30 PM — 12:45 PM
12:45 PM — 1:45 PM
Session 7: Risk Minimization1:45 PM — 2:00 PM
Questions & Answers10:00 AM — 10:15 AM
Review of Day 210:15 AM — 10:45 AM
Session 8: Risk Management Processes11:45 AM — 12:00 PM
12:00 PM — 12:45 PM
Session 10: Post-Approval Requirements for EU-RMPs and REMS12:45 PM — 1:45 PM
Session 11: EU-RMP and REMS Case Studies1:45 PM — 2:00 PM
Question & Answer10:00 AM — 10:15 AM
Review of Day 310:15 AM — 11:15 AM
Session 12: EU-RMP Case Study11:15 AM — 12:15 PM
Session 13: REMS Case Study12:15 PM — 12:30 PM
12:30 PM — 1:15 PM
Session 14: Preparing for Risk Management Audits and Inspections1:15 PM — 1:45 PM
Session 15: Future Direction of Global Risk Management1:45 PM — 2:00 PM
Questions and Answers and Wrap-up