adverse-event-reporting-policy - Draft Adverse Event Reporting Policies
Drafts adverse event reporting policies aligned with FDA, ICH, EMA, PMDA, and Health Canada requirements.
Tags
Updated: 2026-09-30Capabilities
Typical Inputs
Typical Outputs
What this skill does
- Draft reporting policies
- Define AE classifications
- Assign reporting responsibilities
- Assess causality and seriousness
- Set reporting timelines
- Specify documentation standards
- Define training requirements
- Establish quality controls
Inputs
- Organization type
- Product portfolio
- Geographic footprint
- Therapeutic areas
- Existing SOPs
Outputs
- Adverse event reporting policy document
- Reporting procedures
- Documentation and retention requirements