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Étiqueté : ICH

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EMA – Publication of the ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines

This guideline recommends international standards for, and promotes harmonization of, the general principles on planning, designing, analysing, and reporting of noninterventional studies that utilize fit-for-use data for safety assessment of medicines. The guideline outlines recommendations and high-level...