Press release from the ICH Steering Committee meeting in Seville, 9-10 November 2011
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Seville, Spain from 5 - 10 November 2011.
Press release from the MedDRA Management Board meeting in Seville, 5-6 November 2011
The MedDRA Management Board met in Seville, Spain on 5 - 6 November 2011.
Updated MedDRA Guidance available for MedDRA version 14.1
The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents to provide best practice approaches for data entry (coding) and data retrieval/analysis for MedDRA version release 14.1.
ICH E2B(R3) ICSR Implementation Guide released for consultation
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.
Further collaboration with Africa
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).
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 the establishment of an E3 Implementation Working Group (IWG).
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 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
Mandate for the Working Group on Active Substance Master File Procedures/Presentation on the status of the ASMF-project as at March 2022
Mandate for the Working Group on Active Substance Master File Procedures (March 2022)
ICH S6(R1) Step 4, M3(R2) Q&As Step 4 and Quality IWG Points to Consider published on the ICH website
The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline “Revision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.”
Milrinone End of procedure:…
Milrinone End of procedure: 09/04/2011 Date of publication: 06/07/2011