Title
EudraVigilance database
Poster
Description
Denitsa Basheva1, Emil Hristov1, Kalina Andreevska1, Iva Parvova2, Tsvetomir Deliyski1
1Faculty of Chemistry and Pharmacy, SU "St. Kliment Ohridski", Bulgaria
2Department of Rheumatology, Medical University Sofia, Bulgaria
1Faculty of Chemistry and Pharmacy, SU "St. Kliment Ohridski", Bulgaria
2Department of Rheumatology, Medical University Sofia, Bulgaria
Subject
Aim of the study: To investigate the role of EudraVigilance. Materials and methods: A documentary analysis was used. Results: EudraVigilance is a drug safety monitoring system. Its components facilitate electronic reporting of suspected adverse drug reactions and efficient data analysis. This allows early detection of potential safety issues. Reports submitted to EudraVigilance include suspected adverse drug reactions reported pre- and post-authorisation. The system allows the detection of signals of suspected adverse drug reactions that were unknown and new information about known adverse drug reactions. The notification obligations of the various interested parties are set out in EU legislation, specifically in: Regulation (EC) No 726/2004, in Directive 2001/83/EC as amended, in Directive 2001/20/EC and in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of April 16, 2014 on clinical trials of medicinal products for human use and repealing Directive 2001/20/EC. Conclusion: Pharmacovigilance plays a key role in the healthcare system by evaluating, monitoring and detecting drug interactions and their effects on humans.
Keywords: EudraVigilance , adverse drug reactions, database, safety
Keywords: EudraVigilance , adverse drug reactions, database, safety