Hello Guys,
In this article, will see What is Risk management plan (RMP) or Risk management system (RMS) in Pharmacovigilance?
We will also see What is Risk minimisation measure or Risk minimisation activity and Benefit-Risk Balance?
RMP
Risk Management Plan (RMP) is a dynamic, stand-alone document that should be updated throughout the life-cycle of the medicinal product to reflect the increasing knowledge on risks and benefits and the post-marketing experience with the product.
A detailed description of the risk management system.
The risk management plan established by the marketing authorisation holder shall contain the following elements:
- An identification or Characterisation of the safety profile of the medicinal product(s) concerned;
- An indication of how to characterise further the safety profile of the medicinal product(s) concerned; (c) a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those interventions;
- A documentation of post-authorisation obligations that have been imposed as a condition of the marketing authorisation
RMS
Risk management system (RMS) is a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions.
The RMS covers the entire life-cycle of a medicinal product.
Risk minimisation measure or Risk minimisation activity
Interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur.
These activities may consist of routine risk minimisation measures (the summary of product characteristics, the package leaflet, the labelling, the pack size, the legal status of the product, and its formulation) or additional risk minimisation measures (educational programme, controlled access programs, other additional risk minimisation measures).
Benefit-Risk balance
An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health.
The risk-benefit balance of a medicinal product is continuously monitored through pharmacovigilance activities and periodical safety reports, such as DSURs and PBRERs.
We would see other RMP related aspects in upcoming articles.
Regards,
PV & Drug Safety