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The ICH S2(R1) Guideline on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use reached Step 4 of the ICH Process in November 2011 and now enters the Implementation phase (Step 5).
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Seville, Spain from 5 - 10 November 2011.
“International Harmonisation Reaches Milestone on Preclinical Safety”
The MedDRA Management Board met in Seville, Spain on 5 - 6 November 2011.
The Management Board Further Enhances the Use of MedDRA. Seville, 6 November 2011 – The MedDRA Management Board met in Seville, Spain on 5 - 6 November 2011.
The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents for MedDRA version release 14.1.
The E2B(R3) Expert Working Group has finalised the Step 2 ICH Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Data Elements and Message Specification which includes the key parts of the updated E2B(R3) Guideline.
The Steering Committee welcomes the participation of the East African Community (EAC) as the sixth Regional Harmonisation Initiative (RHI) member of the ICH Global Cooperation Group (GCG).