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Risk Management Plans (REMS US (Risk evaluation and minimisation…
Risk Management Plans
REMS US
Risk evaluation and minimisation strategies-risk minimisation measures to ensure that the benefit outweighs the risk
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Medication guides,communication plans and ETASU-elements to assure safe use-may need to monitor and evaluate
Timetable-18 months,3 years and in 7th year after REMS
generics-if reference product has one must have one,can be a single shared system
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Want to identify,characterise,prevent or minimise risks and assess effectiveness of the RMS
Identified risk-an untoward occurence for which there is adequete evidence of an association with the medicinal product of interest.
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Risk minimisation-an intervention intended to prevent or reducr the proability of the occurence of an ADR
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Product overview,safety specification,PV plan,plan for PAES,risk minimisation measures,summary.
Risk minimisation includes-educational programmes,pregnancy prevention programmes.
Measure effectiveness-quantify if the risk is reduced and assess how the drug is used.Survey target patients,prospective observational studies and examining recirds
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