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DC Field | Value | Language |
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dc.date.accessioned | 2020-01-22T09:25:07Z | - |
dc.date.available | 2020-01-22T09:25:07Z | - |
dc.date.issued | 2018-10 | - |
dc.identifier.citation | Camilleri, M., Borg, J. J., Sammut Bartolo, N., & Serracino-Inglott, A. (2018, October). A comparison of approved indications between regulatory agencies. Poster session presented at the ACCP Global Conference on Clinical Pharmacy, Seattle, Washington, USA. | en_GB |
dc.identifier.uri | https://www.um.edu.mt/library/oar/handle/123456789/50747 | - |
dc.description.abstract | A poster presentation regarding a comparison of approved indications between regulatory agencies. Introduction: Medicinal products are allowed on the market following approval by autonomous regulatory agencies which are tasked with their evaluation. Differences in evaluation practices during the registration of medicinal products are found in Europe and the United States of America which may lead to discrepancies in clinical guidelines, pricing policies, and drug use. Aims: To compare the differences in the indications of medicinal products authorised by the European Medicines Agency (EMA) and the US Food & Drug Administration using new molecular entity cardiology-related medicinal products as examples. | en_GB |
dc.language.iso | en | en_GB |
dc.publisher | University of Malta. Department of Pharmacy | en_GB |
dc.rights | info:eu-repo/semantics/openAccess | en_GB |
dc.subject | Drug evaluation -- Standards | en_GB |
dc.subject | Administrative agencies -- Medical care | en_GB |
dc.subject | European Agency for the Evaluation of Medicinal Products | en_GB |
dc.subject | Drugs -- Law and legislation -- United States | en_GB |
dc.subject | Drugs -- Law and legislation -- Europe | en_GB |
dc.subject | Cardiovascular agents | en_GB |
dc.title | A comparison of approved indications between regulatory agencies | en_GB |
dc.type | presentation | 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 | N/A | en_GB |
dc.contributor.creator | Camilleri, Matthew | - |
dc.contributor.creator | Borg, John-Joseph | - |
dc.contributor.creator | Sammut Bartolo, Nicolette | - |
dc.contributor.creator | Serracino-Inglott, Anthony | - |
Appears in Collections: | Scholarly Works - FacM&SPha |
Files in This Item:
File | Description | Size | Format | |
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A_comparison_of_approved_indications_between_regulatory_agencies_2018.pdf | 335.63 kB | Adobe PDF | View/Open |
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