Vaccine Pharmacovigilance & Materiovigilance
6 questions covering the whole module, mixing recall with applied scenarios. Answer everything, then submit — you’ll see your score and every explanation at once. Pass threshold: 70%. Retake as many times as you like.
A batch of vaccines was stored outside the required cold-chain temperature range before administration. Which AEFI category does this fall into?
Why is applying WHO-UMC causality logic directly to a vaccine AEFI a common but consequential error?
Why is an AESI monitored proactively, before any confirmed causal link exists?
A prefilled autoinjector malfunctions and delivers an incorrect medication dose. What is the correct reporting approach?
What determines a medical device’s EU MDR risk classification?
What is the difference between a UDI’s Device Identifier (DI) and Production Identifier (PI)?