This Module is part of the MHRA/DIA Excellence in Pharmacovigilance training course

This module aims also to provide the background for understanding drug-related risks, and to present recent developments regarding risk communication.
In accordance with the GVP Module V on Risk Management System, risk management plans (RMPs) should be submitted by companies to propose activities aiming to identify, characterise or minimise risks associated with medicinal products. Given the potential public health implications and costs of such interventions, RMPs should be based on robust epidemiological methods.