Adverse Event (AE) Reporting
The regulatory obligation to report observed adverse events, including ones first learned about through unexpected channels.
Adverse event reporting is the regulatory obligation a pharma company has to report observed or suspected adverse events linked to its products to the relevant health authority, regardless of how the company learned about the event. That last part is the part people underestimate. An AE doesn't have to come from a formal clinical report to count. A patient comment on a social post, a message to a chatbot, or a line in a call-center transcript can trigger the same reporting obligation as a report from a prescriber.
That's why any patient-facing digital channel a brand runs, a DTC campaign's comment section, a support chatbot, a patient portal, needs a real AE triage process behind it, not just a content review process. Monitoring for compliant claims and monitoring for adverse events are two different jobs, and a channel built to do only one of them has a real gap.