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Drafts an Adverse Event Reporting Policy compliant with 21 CFR 312.32 (IND safety reporting), 21 CFR 314.80 (postmarketing), and ICH E2A, with multi-jurisdictional overlays (EMA, PMDA, Health Canada). Covers seriousness/causality frameworks, expedited reporting timelines, roles, documentation standards, training mandates, and QA mechanisms. Use when drafting or updating an adverse event reporting policy, pharmacovigilance policy, AE/SAE reporting SOP, or safety reporting framework for a pharmaceutical company, CRO, biotech, or clinical research institution.
adverse-event-reporting-policy is an agent skill entry in ChatHome Skills, sourced from GitHub Skill Search and scored 58/100. # Adverse Event Reporting Policy Drafts a binding AE reporting policy meeting FDA requirements and ICH standards for pharma, biotech, CROs, and healthcare organ. As an agent skill, it packages a reusable instruction set that AI coding agents such as Codex and Claude Code can load to perform this task without hand-written glue code. ChatHome Skills discovered this entry through its daily ingest of official registries and GitHub discovery queries, and re-verifies repository facts, freshness signals, and install metadata on every run. The quality score weighs official-registry presence, a working install command, license clarity, GitHub star trajectory, and repository freshness — the full formula is on the Sources page. The install command above is ready to copy. Review the last-pushed date and repository status before adding adverse-event-reporting-policy to a production agent workflow; the snapshot facts below are point-in-time values from the most recent ingest.
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# Adverse Event Reporting Policy Drafts a binding AE reporting policy meeting FDA requirements and ICH standards for pharma, biotech, CROs, and healthcare organizations conducting