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You will find in this section the recent latest new from the ICH.
M3(R2) Q&As on Combination Drug Toxicity Testing available on the ICH website
In December 2011, the ICH M3(R2) Implementation Working Group finalised under Step 4 of the ICH Process an additional set of Questions and Answers addressing Combination Drug Toxicity Testing. This new section was added to the...
Follow in details the main decisions taken by the ICH governing body in November 2011
A comprehensive report of the last ICH meeting that was held in Seville...
Additional Q8/Q9/Q10 Points to Consider added on the ICH website
At its meeting in Seville, in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics covering: Role of Models in Quality by Design (QbD); Design Space; and Process...
Updated ESTRI webpages
At their meetings in Seville, in November 2011, the ICH E2B(R3) and M8 working groups finalised further documentation related to the development of ICH electronic standards.M8 eCTD: The Q&A document summarizing the results...