Translating genomics science into personalized medicine : the regulatory aspect

Abstract

A poster presentation about translating genomics science into personalized medicine: the regulatory aspect. Introduction: Advanced knowledge of the human genome has remodelled the pharmaceutical domain, triggering changes in treatment paradigms and patient expectations. Regulators are anticipated to facilitate adoption of innovative methodologies in practice. Aims: The research group within the Malta Medicines Authority and the Department of Pharmacy at the University of Malta, is conducting pharmacogenetic investigations such as genotyping and its correlation to drug blood levels for amitriptyline, as it relates to regulatory labelling. The level of harmonisation reached on the integration of pharmacogenetic implications in official sources of drug information is assessed.