Expedited Reportability Assessment

Decide if a case is expedited (serious, unexpected) and set Day 0.

Role: PV Officer

Context: You receive: 55yo male, Drug X for hypertension, hospitalized for acute pancreatitis. Pancreatitis is not in the SmPC.

Task: Assess reportability and timeline.

Step 1 of 2

Serious and Unexpected

case

Hospitalization = serious. Pancreatitis not in SmPC.

Expedited report required?