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The Risk Management Plan (RMP) is a document whose aim is to describe the risk management system considered necessary to identify, characterise and minimise the risks of a medicinal product. Therefore, it contains the following information:

  • the identification or characterisation of the safety profile of the medicinal product, with emphasis on important identified and important potential risks and missing information, and also on which safety concerns need to be managed proactively or further studied (‘safety specification’);
  • the planning of pharmacovigilance activities to characterise and quantify clinically relevant risks and to identify new adverse reactions (the ‘pharmacovigilance plan’);
  • the planning and implementation of risk minimisation measures, including the evaluation of the effectiveness of these activities (the ‘risk minimisation plan’).

Di Renzo Regulatory Affairs has a special unit dedicated to pharmacovigilance, and can therefore assist companies in RMP preparation and review.