- Definitions – Pharmacovigilance, Adverse Event (AE), Adverse Reaction by World Health Organization (WHO)
- The ‘S’ Factors
- Serious Adverse Event (SAE) Definitions
- Suspected Adverse Reaction (SAR)
- Suspected Unexpected Serious Adverse Reaction (SUSAR)
- FDA regulations
- Safety Reporting Requirements
- Adverse Event Reporting
- Safety Reporting Regulations
- Drugs and Biologics
- Medical Devices
- Medical Devices Report (MDR) Terminology
- Device Reporting Chart
- Medical Devices Report (MDR) Requirements
- Pre-Marketing Adverse Event (AE) Requirements
- Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting
- Unexpected, Fatal or Life-Threatening Suspected Adverse Event
- How to submit - Industry
- Council for International Organizations of Medical Sciences (CIOMS) Form
- US Investigational New Drug (IND) Safety Reports
- Determining Drug Relationship/Causality
- Other changes
- Adverse Event Reporting via IND Annual Reports
- Post-Marketing Adverse Event (AE) Reporting
- Periodic Safety Reports
Nancy Pire-Smerkanich, DRSc, MS
Associate Director, Regulatory Knowledge and Support