Pharmacovigilance
Risk Management Plan
Risk Management Plan (RMP) support for European Medicines Agency (EMA) submissions
WHAT IS AN RMP?
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).
Risk Management Services
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.
RMP for EudraVigilance
QVigilance also supports the generation and maintenance of RMP
Risk and Signal Management
Risk management dovetails seamlessly with our signal management procedures and all confirmed signals are assessed for risk categorisation (important identified/potential risk or missing information), impact on the benefit-risk of the product safety profile and need for update to the risk management system.
NEED TO OUTSOURCE YOUR RISK MANAGEMENT AND RISK MINIMIZATION ACTIVITIES?
Get in contact with our PV Specialist!
