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The SC is pleased to announce the decision that Health Canada (HC) and Swissmedic are now Steering Committee members.
The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Minneapolis, MN, USA on May 31-June 5, 2014.
ICH MedDRA Management Board Supports MedDRA’s Continuing Evolution.
The Steering Committee will meet in Minneapolis, MN, USA from May 31 to June 5 to discuss ongoing harmonisation activities.
In March 2014, the ICH E2C(R2) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing new concepts and principles linked to an evolution of the traditional PSUR.
In March 2014, the ICH E14 Implementation Working Group finalised under Step 4 of the ICH Process four additional Questions and Answers addressing Concentration-Response Relationships, Combination Products, Large Targeted Proteins and Monoclonal Antibodies and Special Cases.
A comprehensive report of the last ICH meeting that was held in Osaka, Japan on 9-14 November 2013 is now available on the ICH website under the SC Reports page.
On 28 March 2014, DIA and EFPIA are organising an “Information Day on ICH” to provide an update on the status of active topics and potential new topics to be harmonised.