アジェンダ
5:45 AM — 7:45 AM
Pre-Course Work – can be done at any time prior to the live event7:45 AM — 8:30 AM
8:30 AM — 9:00 AM
Session 1: Introduction and Welcome9:00 AM — 9:30 AM
Session 2: Drug Safety Jeopardy9:30 AM — 10:00 AM
Session 3: Lifecycle of Medical Product Safety10:00 AM — 10:15 AM
10:15 AM — 11:00 AM
Session 4: Clinical Trial Safety Regulations – US IND Safety Reporting11:00 AM — 11:45 AM
Session 5: CTTI Webinar11:45 AM — 12:45 PM
12:45 PM — 1:30 PM
Session 6: FDA Guidance for Industry on Safety Reporting2:00 PM — 2:30 PM
Session 8: Assessing Individual Case Safety Reports2:30 PM — 2:45 PM
2:45 PM — 3:45 PM
Session 9: SAE Case Study4:15 PM — 4:45 PM
Session 11: DSUR Executive Summary4:45 PM — 5:00 PM
Day One Wrap-Up/Questions and Answers5:00 PM — 6:00 PM
7:45 AM — 8:30 AM
9:15 AM — 10:00 AM
Session 13: Post-Marketing Safety Regulations – US10:00 AM — 10:15 AM
10:15 AM — 10:45 AM
Session 14: MedWatch Learn10:45 AM — 11:00 AM
Session 15: EMA Web Site11:00 AM — 12:15 PM
Session 16: Post-Marketing Safety Regulations – EU12:15 PM — 1:15 PM
1:15 PM — 2:00 PM
Session 17: Individual Case Safety Reports2:00 PM — 2:45 PM
Session 18: Spontaneous Case Report2:45 PM — 3:00 PM
3:00 PM — 3:45 PM
Session 19: Safety Data Coding3:45 PM — 4:15 PM
Session 20: MedDRA Coding4:15 PM — 5:00 PM
Session 21: Aggregate Reporting for Marketed Products5:00 PM — 5:15 PM
Day Two Wrap-Up/Questions and Answers7:45 AM — 8:30 AM
8:30 AM — 9:00 AM
Session 22: Review the Reporting Matrix Worksheet9:00 AM — 9:30 AM
Session 23: Overview of Case Processing9:30 AM — 10:15 AM
Session 24: Organization of the Safety Department10:15 AM — 10:30 AM
10:30 AM — 11:30 AM
Session 25: Audits and Inspections, Pharmacovigilance System Master File (PSMF)11:30 AM — 12:00 PM
Session 26: FDA Warning Letters12:00 PM — 1:00 PM
1:00 PM — 1:45 PM
Session 27: Benefit-Risk Management1:45 PM — 2:00 PM
Session 28: REMS@FDA web site2:00 PM — 2:15 PM
2:15 PM — 3:15 PM
Session 29: Introduction to Signal Detection3:15 PM — 3:45 PM
Course Wrap-Up/Questions and Answers