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|Title:||Pharmacogenomics information in official drug labelling|
Azzopardi, Lilian M.
|Keywords:||Pharmacogenomics -- Research|
Drugs -- Labeling
United States. Food and Drug Administration
European Agency for the Evaluation of Medicinal Products
|Publisher:||University of Malta. Department of Pharmacy|
|Citation:||Azzopardi, Y., Wirth, F., Camilleri, L., Serracino-Inglott, A., & Azzopardi, L. M. (2019, September). Pharmacogenomics information in official drug labelling. Poster session presented at the 79th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2019, Abu Dhabi, United Arab Emirates.|
|Abstract:||A poster presentation regarding pharmacogenomics information in official drug labelling. Introduction: The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are continually updating drug labels and Summary of Product Characteristic s (SmPC) with pharmacogenomic (PGx) information. Harmonisation of PGx information in drug labelling between regulatory bodies facilitates clinical implementation of PGx. Aims: ● To compare PGx information in official drug labelling between the US FDA and the EMA: Inclusion of PGx information within headings and sub-headings of drug labels and SmPCs ● Quality of PGx information in drug labels and SmPCs.|
|Appears in Collections:||Scholarly Works - FacM&SPha|
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|Pharmacogenomics_information_in_official_drug_labelling_2019.pdf||269.4 kB||Adobe PDF||View/Open|
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