domingo, 23 de febrero de 2014

Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500160232&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc



Guidelines & Recommendations

chess pieces with arrows pointing up
Policy recommendations on using genomic big data for health,External Web Site Icon by Dr Philippa Brice, PHG Foundation, Feb 17


Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

Document details

Download documentDraft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products
Reference numberEMA/281371/2013
Statusdraft: consultation open
First published30/01/2014
Last updated30/01/2014
Consultation start date30/01/2014
Consultation end date30/07/2014
Email address for submissionsPGWPSecretariat@ema.europa.eu

Summary

This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products with pharmacogenomic associations, and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.

No hay comentarios: