FDA Adverse Event Monitoring System (AEMS)
Автор: Regulatory Affairs 101
Загружено: 2026-03-13
Просмотров: 8
Описание:
In this video, I break down the FDA’s new Adverse Event Monitoring System (AEMS) — a unified, AI‑enabled platform that modernizes how safety data is collected, processed, and shared.
You’ll learn what AEMS is, how sponsors can use it, why it matters for regulatory strategy and pharmacovigilance, and when teams should integrate it into their safety workflows.
If you work in regulatory affairs, clinical safety, or post‑marketing surveillance, this update is essential.
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