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

In this series, we will discuss pharmacovigilance and safety reporting in clinical trials. Case studies are presented throughout the series.

Ethics & Participant Safety
Regulatory & Quality Sciences
Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 7: Adverse Event Reporting (2018)
Nancy Pire-Smerkanich, DRSc, MS

Assistant Professor, USC Mann Dept. of Regulatory and Quality Sciences; Associate Director, Regulatory Knowledge and Support

Course Syllabus/Topics

  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

Acknowledgement

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

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NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.