The International Council for Harmonization (ICH) has issued ICH E9 (R1) training materials meant to improve the planning, design, analysis and interpretation of clinical trials by defining suitable ...
The International Council for Harmonisation (ICH) has adopted its M12 guidance, which promotes a harmonized approach in conducting and interpreting enzyme- or transporter-mediated in vitro and ...
This article reviews the scope, key principles, methodological expectations, and regulatory implications of ICH E20, and ...
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...
The final ICH E6 (R3) Good Clinical Practice (GCP) Guidelines were published on 6 th January 2025, updating the framework for clinical trials to reflect modern trial designs, technology, and data ...
ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma ...
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