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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 the establishment of an E3 Implementation Working Group (IWG).
A comprehensive report of the last meeting of the ICH Steering Committee that was held in Cincinnati, OH, US on 11 - 16 June 2011 is now available on the ICH website under the SC Reports page.
The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline “Revision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.”
The ICH Study Group in China translated the ICH booklet as it found it helpful to better understand how ICH Guidelines have been implemented to benefit drug regulatory authorities.
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 3).
“ICH Global Expansion – Enhanced Scientific Exchanges”. The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Cincinnati, Ohio from June 11-16, 2011.
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Cincinnati, Ohio from June 11-16, 2011.
The MedDRA Management Board Congratulates CIOMS Working Group on SMQs for its Important Contribution to Public Health Protection.