Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 7: Adverse Event Reporting (2018)

1. Showing an actual TV commercial about where and how the lists of side effects is generated
2. Adverse Event “Journey”
3. Individual Patient Adverse Event (AE) on Case Report Form (CRF)
4. AEs in Clinical Study Report (CSR)
5. AEs in Integrated Summary of Safety (ISS)
6. AEs by Indication in Clinical Safety Summary
7. AE/Safety Information - FDA Review of Chantix
8. AE of Special Interest - FDA Review of Chantix
9. Benefit Risk Assessment
10. Prescribing Information
11. Prescribing Information - Chantix
12. (Partial) AE list in PI
13. AE “Journey”
14. Purpose of Prescription Drug Product Labelling

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