Risk assessmentRisk assessment is one of the three pillars of risk management (together with safety specifications and the risk minimisation plan). It contains both routine and additional pharmacovigilance activities to characterise the safety profile of the medicinal product including what is known and not(...)
Risk Evaluation and Mitigation StrategyA Risk Evaluation and Mitigation Strategy (REMS) is used in the United States, and is similar to the Risk Management Plan (RMP) in the EU.
Risk factorA risk factor is a characteristic, condition or habit that increases a person’s chances to develop a particular disease or injury, for example, physical inactivity may, over time, contribute to weight gain, high blood pressure and high cholesterol levels. Risk factors include: behavioural(...)
Risk managementRisk management is a process for identifying, assessing, prioritising, and taking the appropriate action to mitigate a risk. The objective of risk management is to continuously try to ensure that the benefits of a particular medicinal product (or a series of medicinal products) exceed the(...)
Risk Management PlanA risk management plan provides a detailed description of the activities and interventions in place to prevent or minimise risks of using a medicine. Risk management plans outline how more knowledge about the safety and efficacy of a medicine will be generated, what are the risk factors for(...)
RMPA risk management plan provides a detailed description of the activities and interventions in place to prevent or minimise risks of using a medicine. Risk management plans outline how more knowledge about the safety and efficacy of a medicine will be generated, what are the risk factors for(...)
Risk minimisation measuresThese are public health 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. Risk minimisation measures aim to optimise the safe and(...)
Routine pharmacovigilance activitiesRoutine pharmacovigilance activities are generally conducted for any medicine in development, where there are no special safety concerns. Activities might include safety evaluation incorporated into clinical trials, and the monitoring and reporting of adverse events. These activities are(...)
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