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DC Field | Value | Language |
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dc.contributor.author | Borg, John-Joseph | - |
dc.contributor.author | Tanti, Amy | - |
dc.contributor.author | Kouvelas, Dimitrios | - |
dc.contributor.author | Lungu, Calin | - |
dc.contributor.author | Pirozynski, Michal | - |
dc.contributor.author | Serracino-Inglott, Anthony | - |
dc.contributor.author | Aislaitner, George | - |
dc.date.accessioned | 2019-10-31T07:28:23Z | - |
dc.date.available | 2019-10-31T07:28:23Z | - |
dc.date.issued | 2015 | - |
dc.identifier.citation | Borg, J. J., Tanti, A., Kouvelas, D., Lungu, C., Pirozynski, M., Serracino-Inglott, A., & Aislaitner, G. (2015). European Union pharmacovigilance capabilities: potential for the new legislation. Therapeutic Advances in Drug Safety, 6(4), 120-140. | en_GB |
dc.identifier.uri | https://www.um.edu.mt/library/oar/handle/123456789/48162 | - |
dc.description.abstract | European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed. | en_GB |
dc.language.iso | en | en_GB |
dc.publisher | Sage Publications Ltd. | en_GB |
dc.rights | info:eu-repo/semantics/openAccess | en_GB |
dc.subject | Drugs -- Side effects | en_GB |
dc.subject | Pharmacovigilance | en_GB |
dc.subject | Administrative agencies -- Europe | en_GB |
dc.subject | Cardiovascular disease diagnostic equipment industry -- Europe | en_GB |
dc.title | European Union pharmacovigilance capabilities : potential for the new legislation | en_GB |
dc.type | article | en_GB |
dc.rights.holder | The copyright of this work belongs to the author(s)/publisher. The rights of this work are as defined by the appropriate Copyright Legislation or as modified by any successive legislation. Users may access this work and can make use of the information contained in accordance with the Copyright Legislation provided that the author must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the prior permission of the copyright holder | en_GB |
dc.description.reviewed | peer-reviewed | en_GB |
dc.identifier.doi | 10.1177/2042098615591802 | - |
dc.publication.title | Therapeutic Advances in Drug Safety | en_GB |
Appears in Collections: | Scholarly Works - FacM&SPha |
Files in This Item:
File | Description | Size | Format | |
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European_Union_pharmacovigilance_capabilities.pdf | 124.72 kB | Adobe PDF | View/Open |
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