The RMP describes the risk management system and contains information regarding identified risks, potential risks and missing information. It outlines any risk minimisation measures adopted and includes information about monitoring the effectiveness of these measures.
All new applications for products within the European Union (EU) require submission of a Risk Management Plan (RMP) to the European Medicines Agency (EMA).
At QVigilance, we offer additional risk management and risk minimisation activities required for safety concerns. These include post-authorisation safety studies (PASS) such as observational studies and registries, generation of targeted questionnaires and designing and implementing educational materials for risk minimisation.
Furthermore, we can assist with the on-going or periodic assessment of the effectiveness of any risk minimisation measures in place per the RMP.