ICH E8(R1): General Considerations for Clinical Studies

ICH E8(R1): General Considerations for Clinical Studies This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. 2023-12-02 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyICH E8(R1)general considerationsclinical studiesICH Expert Working-Groupconsultationregulatory partiesICH Assembly ICH E8(R1): General Considerations for Clinical StudiesHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/efficacy/general-considerations-clinical-trials-topic.html ICH E8(R1): General Considerations for Clinical StudiesHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/efficacite/intention-industrie-considerations-generales-relatives-etudes-cliniques-theme.html

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

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