EudraVigilance (EV)





ADR Adverse Drug Reaction
ADSL Asymmetric Digital Subscriber Line
CHMP Committee for Medicinal Products for Human Use
CVMP Committee for Veterinary Medicinal Products
DBMS Database Management System
DIA Drug Information Association
DTD Data Type Definition
E2B Clinical Safety Data Management: Data Elements for Transmission of ICSRs
EC European Commission
EDI Electronic Data Interchange
EEA European Economic Area
EFPIA European Federation of Pharmaceutical Industries and Associations
EMA European Medicines Agency
ESTRI Electronic Transfer of Regulatory Information Gateway
EU European Union
EV EudraVigilance
EVCTM EudraVigilance Clinical Trials Module
EVMPD EudraVigilance Medical Product Dictionary
EV PM EudraVigilance Post-Authorisation Module
EWG Expert Working Group
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICSRs Individual Case Safety Reports
ICT Information and Communications Technologies
IDA Interchange of Data between Administrations
IMP Investigational Medicinal Product
JIG The Joint Implementation Group
M2 Electronic Standards for Transmission of Regulatory Information (ESTRI)
MAH Marketing Authorisation Holder
MedDRA Medical Dictionary for Regulatory Activities
MedDRA MSSO MedDRA Maintenance and Support Services Organization
MR Mutual Recognition
MS EU Member State
NCS Non Commercial Sponsor of clinical trials
PASS Post-authorisation Safety Study
PMS study Post-Marketing Safety study
PSUR Periodic Safety Update Report
RAS Rapid Alert System
SAR Serious Adverse Drug Reaction
SGML Standard Generalised Markup Language
SMEs Small and Medium Size Enterprises
SPC Summary of Product Characteristics
SUSAR Suspected Serious Unexpected Adverse Reactions
TIG Telematic Implementation Groups
TMC Telematic Management Committee
TSC Telematic Steering Committee
VICH International Co-operation on Harmonization of Technical Requirements of Veterinary Medicinal products
XML Extensible Markup Language


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Last update: Wednesday, 17 October 2012.



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