Predictive biomarker-based assay development in the context of drug development and lifecycle

Published by EMA

EMAPredictive Biomarkers

The proposed concept paper is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. The guideline will provide recommendations on the interface between predictive biomarker-based assays including CDx, and the development and lifecycle of a medicine.

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The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

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Clinical Trials Facilitation and Coordination Group Guidance document for sponsors for a Voluntary Har

Published by EMA

Clinical Trials

The main objectives of the assessment of the CT are to ensure the quality of the IMP and the safety of the trial subjects.

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