The Global Reporting Puzzle

Navigate different reporting requirements across regulatory regions

Role: Global Drug Safety Lead

Context: Your product Cardizol is marketed in the US, EU, and Japan. You need to ensure compliance with each region's reporting requirements.

Task: Determine the correct reporting actions for cases affecting multiple regions.

Step 1 of 3

Case 1: The Non-Serious Report

case

You receive a non-serious adverse event report from a US physician: 55-year-old patient developed mild headache while taking Cardizol. Headache is listed in all regional labeling. Non-serious and expected.

Which regions require reporting of this individual case?