Risk Minimization Measures Section | PharmaBharat Tools

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Risk Minimization Measures Section | PharmaBharat Tools

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Risk Evaluation and Mitigation Strategy(REMS)Additional Risk Minimization Measure(aRMM)Benefit-Risk Balance Risk Management Plan(RMP)Labeling Update Safety Dear Healthcare Professional Letter(DHCPL)Patient Information Leaflet(PIL)Black Triangle Additional Monitoring Contraindication Special Warning Precaution Pediatric Safety Elderly Population Breastfeeding Safety Specification Pharmacovigilance Plan Risk Minimization Plan Safety Concern Missing Information Identified Risk Potential Risk Safety Alert Risk Communication Controlled Distribution Elements to Assure Safe Use(ETASU)Implementation System REMS Safety Communication Plan Healthcare Professional Training Patient Card Prescriber Guide Risk Management System Urgent Safety Restriction(USR)Safety Concern Assessment Important Potential Risk Missing Information Important Crisis Management PV Recall Safety Risk-Benefit Balance Safety Specification Section Pharmacovigilance Plan Section Risk Minimization Measures Section RMP Update RMP Summary Safety Communication to Patients Direct Healthcare Professional Communication(DHPC)Educational Material Risk Minimization Tool Controlled Access Programme Additional Risk Minimization Measures(aRMM)Black Triangle(▼)Controlled Access Program Educational Materials Elements to Assure Safe Use(ETASU)Identified Risk Medication Guide(MedGuide)Missing Information Post-Authorization Efficacy Study(PAES)Post-Authorization Safety Study(PASS)Patient Alert Card Pharmacovigilance Plan Potential Risk Pregnancy Prevention Program(PPP)Pharmacovigilance System Master File(PSMF)Risk Evaluation and Mitigation Strategy(REMS)Risk Minimization Measures(RMM)Risk Minimization Effectiveness Risk Management Plan(RMP)Routine Risk Minimization

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PV Risk ManagementRisk Minimization Measures Section

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Pharmacovigilance Plan Section RMP Update

Risk Minimization Measures Section

Risk Management

Definition

Section of RMP describing aRMMs and effectiveness evaluation.

Example

Part V of EU RMP: risk minimization.

Regulatory source

GVP Module XVI

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