This skill assists regulatory and clinical affairs professionals in generating binding Adverse Event (AE) reporting policies that meet stringent FDA and ICH standards. It provides a structured framework for defining seriousness criteria, establishing expedited reporting timelines (7/15-day), assigning organizational roles, and implementing multi-jurisdictional overlays for global operations. By ensuring all critical compliance components—from causality assessment algorithms to QA mechanisms—are included, the skill streamlines the creation of SOPs and safety frameworks for IND products, medical devices, and postmarketing surveillance.
