Definition

A predefined adverse event that requires enhanced monitoring and specific evaluation due to its potential association with the product or therapeutic class.

Example

For a new biologic, progressive multifocal leukoencephalopathy (PML) is designated as an AESI. Any PML report triggers immediate enhanced follow-up and expedited signal evaluation.

Regulatory source

ICH E2E, Risk Management Plans

Common mistakes

Having overly broad AESI lists that dilute focus, or not operationalizing AESIs with specific monitoring procedures.

Inspector question

How do you define AESIs for your products? What enhanced procedures are in place when an AESI is reported?

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