GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course.
Pharmacovigilance Abbreviations and Interview Questions
AE—Adverse Event
ADR—Adverse Drug Reaction
SAE—Serious Adverse Event
IND—Investigational New Drug
INDA— Investigational New Drug Application
NDA— New Drug Application
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ANDA—Abbreviated new drug application
BLA—Biologics license application
SLA—Service level Agreement
QPPV—Qualified Person for Pharmacovigilance
EMEA-European Medicine Agency
FDA—Food and Drug Administration
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ICSR—Individual Case Safety Report
PSUR—Periodic Safety Update Report
PBRER— Periodic Benefit-risk Evaluation Report
PADER—Periodic Adverse Drug Experience Report
DSUR— Development Safety Update Report
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ACO— Addendum to Clinical. Overview
MICC—Medical Information Call Centre
MLM—Medical Literature Monitoring
GVP—Good Pharmacovigilance Practises
GDP—Good Documentation Practises
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GLP—Good Laboratory Practises
MSSO— Maintenance and Support Services Organization
MedDRA— Medical Dictionary for Regulatory Activities
MAH—Marketing Authorization Holder
SUSAR— Serious and Unexpected Suspected Adverse Reaction
CFR—Code of Federal Regulations
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FAERS—FDA’s Adverse Event Reporting System
VAERS— Vaccine Adverse Events Reporting System
STN—Submission Tracking Number
OTC—Over the Counter
DILIN— Drug-Induced Liver Injury Network
ICH— International Council for Harmonisation
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EU—European Union
IME— Important medical event
DME— Designated Medical Event
QMS—Quality Management System
PASS—Post Authorization Safety Studies
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EVPM —The EudraVigilance Post-Authorisation Module
EVCTM—The EudraVigilance Clinical Trial Module
CTD—Common Technical Document
ARTG— Australian Register of Therapeutic Goods
PI—Product Information
PIL—Product Information Leaflet
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SmPC—Summary of Product Characteristics
TBS— TGA Business Services
AAN— Australian Approved Name
INN– International Non-Proprietary Name
CIOMS—Council for International Organization of Medical Sciences
DMF—Drug Master File
PSMF—Pharmacovigilance System Master File
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DAEN— Database of Adverse Event Notifications
HIPPA— Health Insurance Portability and Accountability Act
MARC— Medicines Adverse Reactions Committee
CARM— Centre for Adverse Reactions Monitoring
WHO—World Health Organization
WTO—World Trade Organization
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AEFI— Adverse Event Following Immunisation
SMARS—Suspected Medicine Adverse Reaction Search
DHCP— Dear Health Care Professional
RMP—Risk Management Plan
CAPA—Corrective Action and Preventive Action
HIPPA— Health Insurance Portability and Accountability Act
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UMC—Uppsala Monitoring Committee
RA—Regulatory Authority
SDEA—Safety Data Exchange Agreement
SRP— Safety Reporting Portal
LLT—Lowest Level Term
PT—Preferred Term
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HLT—High Level Term
HLGT—High Level Group Term
SOC—System Organ Class
SMQ— Standardised MedDRA Queries
EPAR— European Public Assessment Report
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CHMP— Committee for Medicinal Products for Human Use
CVMP— Committee for Medicinal Products for Veterinary Use
PRAC— Pharmacovigilance Risk Assessment Committee
CAT— Committee for Advanced Therapies
COMP— Committee for Orphan Medicinal Products
PDCO— Paediatric Committee
HMPC— Committee on Herbal Medicinal Products
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CTN— Clinical Trials Notification
IMD— Investigational Medical Device
CTX— Clinical Trials Exemption
HREC— Human Research Ethics Committee
IB— Investigator’s Brochure
USM— Urgent Safety Measure
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ASA—Australian Specific Annex
ATMP— Advanced Therapy Medicinal Products
ACM—Advisory Committee on Medicines
ACV —Advisory Committee on Vaccines
ACB— Advisory Committee on Biologicals
CMI— Consumer Medicine Information
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AusPAR— Australian Public Assessment Report
ACPM—Advisory Committee on Prescription Medicines
ACSOM—Advisory Committee on the Safety of Medicines
ADEC—Australian Drug Evaluation Committee
ADR—Adverse Drug Reaction
API—Active Pharmaceutical Ingredient
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CPP—Certificate of a Pharmaceutical Product
DMF—Drug Master File
MoH—Ministry of Health
NCE—New Chemical Entity
NDP—New Drug Product
SMF—Site Master File
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VMP—Validation Master Plan
NCA— National Competent Authorities
AMED—Allied and Complementary Medicine Database
DOI—Document Object Identifier
EEA—European Economic Area
IPA—International Pharmaceutical Abstracts
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IR—Implementing Regulation
NIMP— Non-Investigational Medicinal Product
IMP— Investigational Medicinal Product
MPID—Medicinal Product Identifier
PhPID—Pharmaceutical Product Identifier
EPITT—European Pharmacovigilance Issues Tracking Tool
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CMDh—Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human
DHPC—Direct Healthcare Professional Communication
EEA—European Economic Area
CCDS—Company core data sheet
CCSI—company core safety information
eCTD—Electronic Common Technical Document
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A-CASI—Audio computer-assisted self-interviewing
IVRS—interactive voice response systems
PPP—Pregnancy prevention programme
RMM—Risk minimisation measures
xEVMPD —Extended EudraVigilance Medicinal Product Dictionary
PVIP—Pharmacovigilance Inspection Program
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CoA— Certificate of Analysis
DPA—Data Protection Act
RADAR—Research on Adverse Drug Events and Reports
SRS—Spontaneous Reporting System
EMR—Electronic Medical Records
CEM—Cohort Event Monitoring
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IMMP—Intensive Medicines Monitoring Programme
DSRU—Drug Safety Research Unit
ID—Incidence Density
ISPE—International Society of Pharmacoepidemiology
PEM—Prescription Event Monitoring
TME—Targeted Medical events
ASR—Annual Safety Reports
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IMPACT—Immunization Monitoring Program Active
DMA—Data Mining Algorithms
DA—Disproportionality Analysis
CDC—Centres for Disease Control and Prevention
SET—Safety Evaluation Tools
ROR—Reporting Odds Ratio
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RR—Relative Reporting
PRR—Proportional Reporting Ratio
DEC—Drug Event Combinations
CMI—Consumer Medicine Information
SMT—Safety Management Team
SPRT—Sequential Probability Ratio Testing
CAEFISS—Canadian Adverse Events Following Immunization Surveillance System
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EDI—Electronic Data Interchange
AEMS—Adverse Event Management System
SSI—Significant Safety Issues
IMP—Investigation Medicinal Product
IMD—Investigational Medical Device
PMAB —Prescription Medicines Authorisation Branch
SIU— Signal Investigation Unit
SRR— Safety Related Request
CAP—Centrally Authorised Products
ElViS—Electronic Vigilance System
ISCS—Informatics Service Center of Swissmedic
IBD—International Birth Date
DIBD—Development International Birth Date
ADE—Adverse Drug Event
CDL—Central Drug Laboratory
CRF—Case Report Form
DCGI—Drug Controller General of India
DOV—Date of Vaccination
EPI—Expanded Programme on Immunization
FCIF—Final Case Investigation Form
GCP—Good Clinical Practices
GMP—Good Manufacturing Practices
GLP—Good Laboratory Practices
IPC—Indian Pharmacopoeia Commission
NCC—National Coordinating Centre
NRA—National Regulatory Authority
PCIF—Preliminary Case Investigation Form
PhFI—Public Health Foundation of India
PvPI—Pharmacovigilance Programme of India
E2B— Electronic to Business
FOITT— Federal Office of Information Technology, Systems and Telecommunication
MDN— Message Disposition Notification
NCA— National Competent Authority
RPVZ— Regional Pharmacovigilance Centre
SM—Swissmedic
TPA— Therapeutic Product Act
TPO— Therapeutic Product Ordinance
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