PharmExec Blog

EMA Invites Comments on Good Biomarker Practice

The European Medicines Agency (EMA) has released a consultation on good genomics biomarker practices.

The outcome of the consultation will inform a guideline, which will set criteria to underpin the generation of robust clinical genomic datasets throughout a medicine’s lifecycle,  the choice of genomic techniques and biomarkers, the impact on the relevant study design, and the appropriate level of analysis and reporting of genomic data. The goal is to enhance transparency, consistency, reproducibility and cross-validation between genomic-driven studies.

Comments on the paper are invited until October 31, 2014 and should be sent to pgwpsecretariat@ema.europa.eu.

 

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