RMP in Pharmacovigilance

PharmExpert LLC supports marketing authorization holders (MAH) on establishing Risk Management Plan (RMP) in pharmacovigilance. This system ensures critically review of the knowledge on the product’s safety profile, following its use in clinical practice.

The authorization of medicinal product happens due to the specified indication(s), that at the time of authorization, the risk-benefit balance is positive for the target population. Generally, a medicinal product causes adverse reactions with discrepancy in severity, likelihood of occurrence, effect on patients and public health impact. However, not all adverse reactions and risks will have been identified at the time when an initial marketing authorization is granted. Moreover, the system can discover or characterise so me of them only in the post-authorisation phase. 

The RMP is developed in accordance with the requirements for each section established by the Good Pharmacovigilance Practice Rules at the local, regional or global levels.

Risk Management

RMP aims for the risks of drugs`evaluation at regular intervals or in response to the post-marketing surveillance and pharmacovigilance activities. This is done in order to minimize the risks of drugs.

The aim of a risk management plan (RMP) in pharmacovigilance is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. To this end, the RMP contains:

• 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 managing safety concerns;
• the planning of pharmacovigilance activities to characterise and quantify clinically relevant risks, and to identify new adverse reactions;
• the planning and implementation of risk minimisation measures, including the evaluation of the effectiveness of these activities.                                   

Our Responsibility in RMP

PharmExpert continuously monitors pharmacovigilance data to determine new risks or whether risks have changed. Moreover, the company observes changes to the risk-benefit balance of medicinal products and update the RMP with further submission to regulatory body.

The application of Risk Minimization Measures (RMM) and Additional Risk Minimization Measures (aRMM) is explained in the relevant sections of our website.