Monitoring and responding to adverse events of special interest (AESIs)

This module introduces the concept of adverse events of special interest (AESIs) which is a novel concept for many countries and regulatory agencies. It provides guidance on the selection and definition of these events. The need to prepare data on background rates of adverse events of special interest and to implement active surveillance for these events is discussed.

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mODULE MATERIALS 

tRAINING MATERIALS