Definition

Monitoring of social media and digital channels for potential adverse event reports or product complaints; EMA and FDA have issued guidance on handling.

Example

Screening company-owned social media and designated hashtags for AE mentions.

Regulatory source

EMA guidance on social media, FDA social media guidance

Common mistakes

Ignoring or under-documenting social media reports.

Inspector question

How do you monitor and process potential AEs from social media?

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