EU Risk Management Plan (EU-RMP)
Diapharm supports companies in the consumer healthcare and pharmaceutical sectors in developing and implementing an appropriate Risk Management Plan (RMP) for pharmacovigilance.
Pharmacovigilance Risk Management
When applying for marketing authorization, pharmaceutical companies are required to submit an EU Risk Management Plan (EU-RMP) that outlines pharmacovigilance measures as well as risk management and risk analysis activities. Guidance for preparing an EU-RMP is provided in the “Guideline on Good Pharmacovigilance Practices” (GVP) Module V. Diapharm identifies potential risks associated with the medicinal product (risk analysis) and prepares a suitable risk management plan.
The EU-Risk Management Plan for pharmacovigilance must systematically identify, assess, and minimize all foreseeable risks according to the current state of scientific knowledge — including risks to product quality.
Diapharm identifies potential risks associated with the medicinal product (risk analysis) and prepares appropriate risk management plans.
