アジェンダ
8:15 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Introduction8:45 AM — 9:15 AM
Session 1: Course Overview9:15 AM — 9:45 AM
Session 2: Risk Management Jeopardy9:45 AM — 10:30 AM
Session 3: What is Risk Management10:30 AM — 10:45 AM
10:45 AM — 11:45 AM
Session 4: Session 4: Global Risk Management Guidelines and Regulations11:45 AM — 12:15 PM
Session 5: Activity12:15 PM — 1:00 PM
1:00 PM — 2:00 PM
Session 6: Content of a US Risk Evaluation & Mitigation Strategy (REMS)2:00 PM — 2:15 PM
2:15 PM — 3:30 PM
Session 7: Content of an EU Risk Management Plan (EU-RMP)3:30 PM — 4:45 PM
Session 8: Risk Management Processes and Governance4:45 PM — 5:00 PM
Questions and Answers and Day One Wrap-Up8:15 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Introduction to Day Two8:45 AM — 9:15 AM
Session 9: Development of the Risk Management Strategy9:15 AM — 10:15 AM
Session 10: Authoring and Submission of Risk Management Documents10:15 AM — 10:30 AM
10:30 AM — 11:15 AM
Session 11: Post-Approval Requirements for EU-RMPs and REMS11:15 AM — 12:15 PM
Session 12: EU-RMP and REMS Case Studies12:15 PM — 1:00 PM
1:00 PM — 2:00 PM
Session 13: EU-RMP Case Study2:00 PM — 2:15 PM
2:15 PM — 3:15 PM
Session 14: REMS Case Study3:15 PM — 4:15 PM
Session 15: Preparing for Risk Management Audits and Inspections4:15 PM — 4:45 PM
Session 16: Future Direction of Global Risk Management4:45 PM — 5:00 PM
Questions and Answers and Wrap-Up