Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 2: Regulatory Requirements (2018)

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

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