Agenda
7:45 AM — 8:30 AM
8:30 AM — 8:45 AM
Session 1: Introduction and Welcome9:15 AM — 9:45 AM
Session 3: Definitions of Drug Safety9:45 AM — 10:00 AM
Session 4: Exercise I10:00 AM — 10:15 AM
10:15 AM — 11:00 AM
Session 5: Regulation of Medicines11:00 AM — 11:30 AM
Session 6: Consensus Organizations11:30 AM — 12:00 PM
Session 7: Life Cycle of Medical Product Safety12:00 PM — 1:00 PM
1:00 PM — 1:30 PM
Session 8: Clinical Trial Safety Regulations – US IND Safety Reporting1:30 PM — 2:00 PM
Session 9: Exercise II2:30 PM — 2:45 PM
2:45 PM — 3:15 PM
Session 11: Assessing Individual Case Safety Reports3:15 PM — 3:45 PM
Session 12: Exercise III4:15 PM — 4:45 PM
Session 14: Exercise IV4:45 PM — 5:00 PM
Day One Wrap-Up/Questions and Answers5:00 PM — 6:00 PM
7:45 AM — 8:30 AM
9:00 AM — 9:30 AM
Session 16: Postmarketing Safety Regulations – US9:30 AM — 10:00 AM
Session 17: Exercise V10:00 AM — 10:15 AM
10:15 AM — 10:45 AM
Session 18: Postmarketing Safety Regulations – EU10:45 AM — 11:15 AM
Session 19: Exercise VI11:15 AM — 12:00 PM
Session 20: Postmarketing Safety Regulations – EU (continued)12:00 PM — 1:00 PM
1:00 PM — 1:30 PM
Session 21: Individual Case Safety Reports1:30 PM — 1:45 PM
Session 22: Exercise VII1:45 PM — 2:30 PM
Session 23: Safety Data Coding2:30 PM — 2:45 PM
2:45 PM — 3:15 PM
Session 24: Exercise VIII3:15 PM — 4:30 PM
Session 25: Aggregate Reporting for Marketed Products4:30 PM — 5:00 PM
Day Two Wrap-Up/Questions and Answers7:45 AM — 8:30 AM
8:30 AM — 9:15 AM
Session 26: Overview of Case Processing9:15 AM — 10:00 AM
Session 27: Organization of the Safety Department10:00 AM — 10:30 AM
10:30 AM — 11:30 AM
Session 28: Audits and Inspections, Pharmacovigilance System Master File (PSMF)11:30 AM — 12:00 PM
Session 29: Exercise IX12:00 PM — 1:00 PM
1:00 PM — 1:45 PM
Session 30: Benefit-Risk Management1:45 PM — 2:00 PM
Session 31: Exercise X2:00 PM — 2:15 PM
2:15 PM — 3:15 PM
Session 32: Introduction to Signal Detection3:15 PM — 3:45 PM
Course Wrap-Up/Questions and AnswersHave an account?