Hi All,
Below are the most common Pharmacovigilance (PV) Abbreviations.
ADR: Adverse Drug Reaction
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