adverse-event-reporting-policy
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.
Installation and usage
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.
После установки вы можете использовать этот skill, выполнив следующую команду в терминале:
skills use adverse-event-reporting-policy