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Pharmacovigilance Glossary

Adverse Drug Reaction (ADR)

Adverse Event of Special Interest (AESI)

Aggregate reports

Association

Benefit

Benefit-risk assessments

Benefit-risk balance (or effectiveness/risk)

CIOMS- Council for International Organizations of Medical Sciences

Case reports/ Individual Case Safety/Study Report (ICSR)

Causal relationship

Causality assessment

Clinical development program

Clinical trial, clinical study

Company Core Data Sheet (CCDS)

Company Core Safety Information (CCSI)

Critical terms

DME (Designated Medical Event)

Data Monitoring Committee

Dechallenge

Development core safety information (DCSI)

Development pharmacovigilance and risk management plan

Disproportionality analysis

Drug Abuse

EUDRAGENE

Efficacy

EudraVigilance

EudraVigilance Medicinal Product Dictionary (EVMPD)

European Medicines Agency (EMA)

Expected adverse drug reaction

Expedited Reporting

Frequency of ADRs

Good pharmacovigilance practice (GDP)

Harm

Hazard

ICH

Important medical event (IME)

Incidence

Insife

International Serious Adverse Events Consortium (iSAEC)

Marketing Authorization Holder (MAH)

Medical Dictionary for Regulatory Activities (MedDRA)

Medication error

Minimum criteria for reporting

Missing information

National pharmacovigilance centers or National Competent Authority (NCA)

Near-misses

Number needed to harm (NNH)

Odds and Odds Ratio

Off-label use or Misuse

Overdose

Pharmacoepidemiology

Pharmacology

Pharmacovigilance

Pharmacovigilance System Master File (PSMF)

Pharmacovigilance system

Post-authorization safety study (PASS)

Postmarketing surveillance

Predisposing factors

Prescription event monitoring (PEM)

Prevalence

QPPV

Rational drug use (RDU)

Rechallenge

Reference risk (or baseline risk)

Risk

Risk Management Plan (RMP)

Risk management

Risk minimization activity

Safety

Safety concern

Safety specification

Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)

Signal

Signal management process

Signal validation

Solicited reports

Spontaneous reporting

Summary of product characteristics (SmPC)

Suspected unexpected serious adverse reaction (SUSAR)

Temporal relationship

Type (A to F) of adverse drug reaction

Unexpected adverse drug reaction

United States Prescribing Information (USPI)

Unlabelled (or labelled)

Vigibase

WHO

WHO DD (WHO Drug Dictionary)

WHOART (WHO Adverse Reactions Terminology)

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