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You will find in this section the recent latest new from the ICH.
Additional M3(R2) Q&As available on the ICH website
In March 2012, the ICH M3(R2) Implementation Working Group finalised under Step 4 of the ICH Process an additional set of Questions and Answers addressing Safety Pharmacology, Exploratory Clinical Trials, Reproductive Toxicity...
ICH E2C(R2) reaches Step 2 of the ICH Process
The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 2 of the ICH Process in February 2012 and now enters the consultation period (Step 3). The purpose of this revised guidance is to ensure that the...
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, Spain on 5 - 10 November 2011 is now available on the ICH website under the SC Reports page. This report outlines the main decisions taken by the ICH...