Press release from the MedDRA Management Board meeting in San Diego, 10-11 November 2012
The MedDRA Management Board met in San Diego, CA, USA on 10-11 November 2012.
Draft ICH eCTD Implementation Guide undergoing Step 2 for Testing
In October 2012, the Draft eCTD Implementation Guide (v0.1) was released under Step 2 for Testing to give an opportunity to stakeholders to conduct testing to confirm its technical feasibility.
Follow in details the discussions from the ICH GCG in June 2012
The final meeting report of the last Global Cooperation Group (GCG) meeting that was held in Fukuoka, Japan on June 5, 2012 is now available on the ICH website under the GCG Reports page.
Updated MedDRA Guidance available for MedDRA version 15.1
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 15.1.
Press release from the ICH Steering Committee meeting in Fukuoka, 6-7 June 2012
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Fukuoka, Japan on June 2-7, 2012.
E3 Q&As on Structure and Content of Clinical Study Reports available on the ICH website
In June 2012, the ICH E3 Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing Content and Structure, Appendices and Terminology questions.
Press release from the MedDRA Management Board meeting in Fukuoka, 2-3 June 2012
The MedDRA Management Board met in Fukuoka, Japan on 2-3 June 2012.
The Steering Committee endorses the establishment of an S1 EWG
In April 2012, the Steering Committee approved the S1 Concept Paper and Business Plan proposing to develop new guidance on rodent carcinogenicity testing.
ICH Q11 reaches Step 4 of the ICH Process
The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 4 of the ICH Process on 1 May 2012 and now enters the Implementation phase (Step 5).
Updated MedDRA Guidance available for MedDRA version 15.0
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 15.0. The revised documents are available for download on the ICH website, under the MedDRA Point to Consider page.