Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 2: Regulatory Requirements (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 2: Regulatory Requirements (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. Definitions – Pharmacovigilance, Adverse Event (AE), Adverse Reaction by World Health Organization (WHO)
  2. The ‘S’ Factors
  3. Serious Adverse Event (SAE) Definitions
  4. Suspected Adverse Reaction (SAR)
  5. Suspected Unexpected Serious Adverse Reaction (SUSAR)
  6. FDA regulations
  7. Safety Reporting Requirements
  8. Adverse Event Reporting
  9. Safety Reporting Regulations
    1. Drugs and Biologics
    2. Medical Devices
  10. Medical Devices Report (MDR) Terminology
  11. Device Reporting Chart
  12. Medical Devices Report (MDR) Requirements
  13. Pre-Marketing Adverse Event (AE) Requirements
  14. Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting
  15. Unexpected, Fatal or Life-Threatening Suspected Adverse Event
  16. How to submit - Industry
  17. Council for International Organizations of Medical Sciences (CIOMS) Form
  18. US Investigational New Drug (IND) Safety Reports
  19. Determining Drug Relationship/Causality
  20. Other changes
  21. Adverse Event Reporting via IND Annual Reports
  22. Post-Marketing Adverse Event (AE) Reporting
  23. Periodic Safety Reports

Acknowledgement

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

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