アジェンダ
7:45 AM — 8:30 AM
8:00 AM — 9:00 AM
8:30 AM — 8:45 AM
Introduction and Welcome8:45 AM — 9:15 AM
Session 1: The Basics: Why We Do What We Do9:15 AM — 9:30 AM
Session 2: Important Consensus Organizations9:30 AM — 10:00 AM
Session 3: Regulation of Medicines10:00 AM — 10:30 AM
10:30 AM — 11:15 AM
Session 4: Definitions and Concepts for Drug Safety11:45 AM — 12:00 PM
Session 6: Group Exercise I: Oncology Product12:00 PM — 1:00 PM
1:00 PM — 1:30 PM
Session 6: Group Exercise I: Oncology Product (continued)2:45 PM — 3:15 PM
3:15 PM — 4:00 PM
Session 9: Coding and Data Classification4:00 PM — 4:20 PM
Session 10: Aggregate Reporting, Part 14:20 PM — 4:50 PM
Session 11: Aggregate Reporting, Part 24:50 PM — 5:00 PM
Questions and Answers5:00 PM — 6:00 PM
7:45 AM — 8:30 AM
8:30 AM — 9:00 AM
Session 12: Risk Assessment in Clinical Trials9:00 AM — 9:20 AM
Session 13: Data Safety Monitoring Boards9:20 AM — 9:45 AM
Session 14: CROs and Out-Sourcing9:45 AM — 10:15 AM
10:15 AM — 10:45 AM
Session 15: Good Clinical Practices and Quality Indicators10:45 AM — 11:15 AM
Session 16: Group Exercise II: Monitoring Development of a Novel Anti-Psychotic11:15 AM — 12:00 PM
Session 17: Audits and Inspections, Part 112:00 PM — 1:00 PM
1:00 PM — 1:45 PM
Session 18: FDA Review of Clinical Trial Data in an NDA or BLA1:45 PM — 2:45 PM
Session 19: Keys to Learning, Part 12:45 PM — 3:15 PM
3:15 PM — 3:45 PM
Session 20: Benefit-Risk3:45 PM — 4:50 PM
Session 21: Risk Management4:50 PM — 5:00 PM
Questions and Answers7:45 AM — 8:30 AM
9:30 AM — 9:45 AM
Session 23: EU Landscape9:45 AM — 10:15 AM
10:15 AM — 10:40 AM
Session 23: EU Landscape (continued)10:40 AM — 11:10 AM
Session 24: Aggregate Reporting, Part 311:10 AM — 11:30 AM
Session 25: Safety Signals11:30 AM — 12:00 PM
Session 26: Principles of Pharmacoepidemiology1:00 PM — 1:20 PM
Session 27: Safety Data Exchange Agreements1:20 PM — 2:00 PM
Session 28: Audits and Inspections, Part 22:00 PM — 2:30 PM
Session 29: Responding to the Inspection2:30 PM — 2:45 PM
2:45 PM — 3:15 PM
Session 30: Keys to Learning, Part 23:15 PM — 3:45 PM
Session 31: Ethics and Conflicts of Interest3:45 PM — 4:00 PM
Questions and Answers and Review of Learner’s Assessment