The European Medicines Agency (EMA) provides regulatory and scientific support to help acadmeics develop medicines
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Predictive biomarker-based assay development in the context of drug development and lifecycle
Published by EMA
EMAPredictive BiomarkersThe 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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ICH: Safety
Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)EMA
Biotechnological ProductPhotosafety EvaluationTherapeutic Area-SpecificImmunotoxicology StudySafety Pharmacology StudyReproductive ToxicologyNonclinical Safety in Paediatric MedicineRepeat-Dose ToxicityToxicokinetics and PharmacokineticsGenotoxicity StudyCarcinogenicity StudyThe 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)
View this resource Bookmark this resourceThe 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 TrialsThe 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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