What AI Signal Detection in Pharmacovigilance - FDA/EMA Best Practices 2026 requires
Detailed framework for validation, qualification, and ongoing performance monitoring of AI/ML systems used for adverse event signal detection, case processing, and aggregate reporting.
Pillar: Medical & Healthcare · Authority: FDA & EMA · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-11
SHA-256 integrity: b09df711319be188684537738eed9b4fb0e0296c61cc19a156b5aa4def6be30a
Primary Citations — 5 traced to source
- FDA Guidance for Industry: Pharmacovigilance Assessment of Cardiovascular Risk of New Drugs
- EMA Guideline on Good Pharmacovigilance Practices: Module IX - Signal Management
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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