Most common Pharmacovigilance Abbreviations

Hi All,

Below are the most common Pharmacovigilance (PV) Abbreviations.

ADR: Adverse Drug Reaction

AE: Adverse Event

AEFI: Adverse Event Following Immunization

AESI: Adverse Event of Special Interest

aRMM: Additional Risk Minimisation Measures

ATMP: Advanced Therapy Medicinal Product

CCDS: Company Core Data Sheet

CCSI: Company Core Safety Information

CHMP: Committee for Medicinal Products for Human Use

CIOMS: Council for International Organizations of Medical Sciences

CMDh: Coordination Group for Mutual Recognition and Decentralised Procedures – Human

DDPS: Detailed Description of the Pharmacovigilance System

DEC: Drug Event Combination

DHPC: Direct Healthcare Professional Communication

DIBD: Development International Birth Date

DLP: Data Lock Point

DME: Designated Medical Event

DSUR: Development Safety Update Report

eCTD: Electronic Common Technical Document

eRMR: Electronic Reaction Monitoring Report

EEA: European Economic Area

EMA: European Medicines Agency

EPAR: European Public Assessment Report

EPITT: European Pharmacovigilance Issues Tracking Tool

eRMR: Electronic Reaction Monitoring Report

EU: European Union

EudraCT: European Clinical Trials Database

EURD: EU Reference Date

EV: EudraVigilance

EVCTM: EudraVigilance Clinical Trial Module

EVDAS: EudraVigilance Data Analysis System

EV EWG: EudraVigilance Expert Working Group

EVMPD: EudraVigilance Medicinal Product Dictionary

EVPM: EudraVigilance Post-Authorisation Module

EVWEB: EudraVigilance Web Application

FAERS: FDA Adverse Event Reporting System

GCP: Good Clinical Practice

GVP: Good Pharmacovigilance Practices

HLGT: Higher Level Group Term

HLT: High-Level term

IBD: International Birth Date

ICH: The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use

ICSR: Individual Case Safety Report

IME: Important Medical Event

INN: International Non-proprietary Name

MA: Marketing Authorisation

MAH: Marketing Authorisation Holder

ME: Medication Error

MedDRA: Medical Dictionary for Regulatory Activities

MLM: Medical Literature Monitoring

NCA: National Competent Authority

PAES: Post-Authorisation Efficacy Study

PASS: Post-Authorisation Safety Study

PBRER: Periodic Benefit-Risk Evaluation Report

PhV: Pharmacovigilance

PL: Package Leaflet

PPP: Pregnancy Prevention Programme

PRAC: Pharmacovigilance and Risk Assessment Committee

PRR: Proportional Reporting Ratio

PSMF: Pharmacovigilance System Master File

PSUR: Periodic Safety Update Report

PT: Preferred Term

QPPV: Qualified Person for Pharmacovigilance

RCT: Randomised clinical Trial

RMM: Risk minimisation Measure

RMP: Risk management Plan

ROR: Reporting Odds Ratio

SAE: Serious Adverse Event

SAR: Serious Adverse Reaction

SDR: Signal of Disproportionate Reporting

SmPC: Summary of Product Characteristics

SMQ: Standardised MedDRA query

SOC: System Organ Class

SUSAR: Suspected Unexpected Serious Adverse Reaction

USFDA: United States Food & Drug Administration

WHO: World Health Organization

WHO DD: WHO Drug Dictionary

xEVMPD: eXtended EudraVigilance Medicinal Product Dictionary

Leave a Comment

Your email address will not be published. Required fields are marked *