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Pharmacovigilance Glossary
Adverse Drug Reaction (ADR)
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Adverse Event of Special Interest (AESI)
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Aggregate reports
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Association
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Benefit
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Benefit-risk assessments
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Benefit-risk balance (or effectiveness/risk)
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CIOMS- Council for International Organizations of Medical Sciences
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Case reports/ Individual Case Safety/Study Report (ICSR)
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Causal relationship
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Causality assessment
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Clinical development program
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Clinical trial, clinical study
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Company Core Data Sheet (CCDS)
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Company Core Safety Information (CCSI)
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Critical terms
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DME (Designated Medical Event)
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Data Monitoring Committee
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Dechallenge
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Development core safety information (DCSI)
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Development pharmacovigilance and risk management plan
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Disproportionality analysis
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Drug Abuse
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EUDRAGENE
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Efficacy
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EudraVigilance
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EudraVigilance Medicinal Product Dictionary (EVMPD)
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European Medicines Agency (EMA)
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Expected adverse drug reaction
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Expedited Reporting
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Frequency of ADRs
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Good pharmacovigilance practice (GDP)
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Harm
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Hazard
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ICH
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Important medical event (IME)
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Incidence
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Insife
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International Serious Adverse Events Consortium (iSAEC)
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Marketing Authorization Holder (MAH)
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Medical Dictionary for Regulatory Activities (MedDRA)
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Medication error
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Minimum criteria for reporting
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Missing information
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National pharmacovigilance centers or National Competent Authority (NCA)
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Near-misses
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Number needed to harm (NNH)
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Odds and Odds Ratio
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Off-label use or Misuse
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Overdose
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Pharmacoepidemiology
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Pharmacology
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Pharmacovigilance
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Pharmacovigilance System Master File (PSMF)
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Pharmacovigilance system
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Post-authorization safety study (PASS)
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Postmarketing surveillance
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Predisposing factors
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Prescription event monitoring (PEM)
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Prevalence
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QPPV
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Rational drug use (RDU)
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Rechallenge
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Reference risk (or baseline risk)
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Risk
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Risk Management Plan (RMP)
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Risk management
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Risk minimization activity
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Safety
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Safety concern
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Safety specification
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Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
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Signal
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Signal management process
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Signal validation
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Solicited reports
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Spontaneous reporting
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Summary of product characteristics (SmPC)
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Suspected unexpected serious adverse reaction (SUSAR)
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Temporal relationship
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Type (A to F) of adverse drug reaction
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Unexpected adverse drug reaction
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United States Prescribing Information (USPI)
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Unlabelled (or labelled)
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Vigibase
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WHO
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WHO DD (WHO Drug Dictionary)
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WHOART (WHO Adverse Reactions Terminology)
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