Definition

The process of informing relevant stakeholders (regulators, healthcare professionals, patients) about confirmed safety signals and any resulting actions.

Example

Following confirmation of a serious hepatotoxicity signal, communication includes: regulatory notification, DHPC to healthcare professionals, patient information update, and label revision.

Regulatory source

EU GVP Module XV

Common mistakes

Delaying communication or providing inconsistent messages to different stakeholders.

Inspector question

How do you coordinate signal communication to different stakeholders? Show me a recent example.

Related terms