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You will find in this section the recent latest new from the ICH.
The Steering Committee endorses the establishment of an E3 IWG
In June 2011, the ICH Steering Committee approved the E3 Q&As Concept Paper to develop Questions and Answers to facilitate the application of the ICH E3 Guideline: Structure and Content of Clinical Study Reports and endorsed...
Follow in details the main decisions taken by the ICH governing body in June 2011
A comprehensive report of the last meeting of the ICH Steering...
ICH S6(R1) Step 4, M3(R2) Q&As Step 4 and Quality IWG Points to Consider published on the ICH website
At the ICH Steering Committee meeting in Cincinnati, OH, US in June 2011, several documents were finalised and are now available for public awareness on the ICH website:
ICH Q11 reaches Step 2 of the ICH Process
The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 2 of the ICH Process in May 2011 and now enters the consultation period (Step...