EU risk management plan (EU-RMP)

The scope, form and documentation used in pharmaceutical risk management should be tailored to suit the specific risks in question. Diapharm supports consumer healthcare and pharmaceutical companies in creating and implementing appropriate pharmacovigilance risk management plans (RMPs).

Pharmacovigilance and risk management

As soon as they apply to register a medicinal product, pharmaceutical companies have to submit an EU risk management plan (EU-RMP) that provides details of pharmacovigilance precautions and measures for risk analysis and for minimising risk. Module V of the guideline on good pharmacovigilance practices (GVP) provides support when it comes to drafting an EU-RMP. We identify potential risks associated with a medicinal product (risk analysis) and create an appropriate risk management plan. In addition we can also manage the project.

At your request, we can of course also assume responsibility for monitoring pharmacovigilance for you.

An EU-RMP for pharmacovigilance must provide a systematic means of recognising, evaluating and minimising all expected risks – including risks to product quality. We support pharmaceutical companies in providing patients and medicinal products with the very best in protection.

Dr. Christoph Buss
Associate Director Pharmacovigilance & Scientific Information

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