Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 5: Safety Reporting in Industry-Sponsored Trials and Case Studies - Part 1 (2018)

1. Collection of Adverse Events (AEs)
2. Adverse Event vs Reaction
3. Who determines AE vs Reaction?
4. Serious Adverse Event (SAE) Reporting Decision Tree
5. Who makes SAE assessments?
6. Seriousness
7. Severity
8. Related vs Unrelated - Sponsor
9. Expected vs Unexpected - Sponsor
10. Analysis of Similar Events - Sponsor
11. Sponsor Medical Comment
12. Reporting: 7-day alert
13. Reporting: 15-day alert
14. Reporting: Unblinding/Unmasking
15. 21 CFR 803.3 - Definitions
16. 803.12
17. 803.53 - Manufacturer: 5-day report
18. 21 CFR 803.50(a) MDR: 30-day report
19. 21 CFR 820.198(a)(3) Complaints: Evaluate for Medical Device Reporting
20. 21 CFR 803.3 - Who reports?
21. Exercise-1: Clinical Trial Adverse Event
    The case study gives a practical view of SAE reporting – right from how it is to be done, duration and also the kind of terms to be used in the form.

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu