Risk management plan (RMP)

RMP is a thorough document of the company’s risk management process for PhV activities.

RMP should be updated throughout the life cycle of the medicinal product and includes information that has to meet the following requirements:

1. Establish and characterize the drug safety profile
2. Indicate how the subsequent characterization of the drug safety profile can be made for
3. Document the steps that will be implemented to prevent/minimize the risks associated with the use of the drug
4. Document compliance with post-registration requirements

If you need assistance for developing an RMP following the introduction of updated EEU GVP requirements, the experts of Aston’s PhV Department are at your disposal.