PHARMA SECTOR ASKED FOR COMMENTS ON NEW PHARMACOGENETIC PHARMACOVIGILANCE GUIDANCE
February 1st, 2014
EUROPEAN pharma companies have been asked for comments on a new European Medicines Agency (EMA) guideline that says how pharmacogenomics can support pharmacovigilance activities, especially how studies into personalised medicines can optimise usage. EMA advises on how assessments of these medicines can be turned into appropriate labelling recommendations. And also on how pharmacogenomics can be implemented “in risk-management plans, risk-minimisation measures, signal detection and the benefit-risk evaluation of medicines with an established link between ...
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