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PP040—Drug information unit–valuable source of information, novi sad experience

Authors :
Ana Sabo
Velibor Vasović
Olga Horvat
Boris Milijašević
Aleksandar Rašković
Nebojša Stilinović
Saša Vukmirović
Zdenko Tomić
Source :
Clinical Therapeutics. 35:e30
Publication Year :
2013
Publisher :
Elsevier BV, 2013.

Abstract

e30 Volume 35 Number 8S Conclusion: LHA tends to accept EU requirements as much as it could match local regulation, but local regulation differs significantly from EU. As a consequence, LSU makes additional efforts and communications with LHA and Company, to fulfill each requirement in its own way. The differences could be overcome with harmonization of local regulation with EU and if LHA receive access to EudraVigilance database. Disclosure of Interest: None declared.

Details

ISSN :
01492918
Volume :
35
Database :
OpenAIRE
Journal :
Clinical Therapeutics
Accession number :
edsair.doi.dedup.....54fbd35945b22699e682afa0c561972b
Full Text :
https://doi.org/10.1016/j.clinthera.2013.07.072