ICH: Report of ICH Steering Committee

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ICH: Report of ICH Steering Committee

Сообщение News » 11 окт 2014 23:37

ICH: Report of ICH Steering Committee

A comprehensive report of the last ICH meeting, which was held in Minneapolis, MN, USA, on 4-5 June 2014, is now available on the ICH website under the SC Reports page.
This report outlines the main decisions taken by the ICH Governing Body including feedback from discussions of the MedDRA Management Board and discussion during the Global Cooperation session. The report summarises also the main progress made by each ICH technical working groups (IWGs) since the last meeting in November 2013.
Q7 IWG: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
The Rapporteur reported to the SC on the outcome of the Q7 IWG meeting held in Minneapolis on and progress made in the development of the ICH Q7 Q&A document. The SC noted that the IWG collected comments from constituencies on the first set of 23 Q&As and anticipated to review the feedback received after the Minneapolis meeting.The first set of draft Q&As is expected to be finalised by the end of September 2014.
A second set of draft Q&As would be reviewed by the constituencies of each party by the end of June 2014 during four months. Based on feedback received, the group proposed to the SC that the Q&As could go directly to Step 4 without the need of regional consultation.
It was noted that the group was expecting to finalise its work on the ICH Q&As by the end of June 2015.

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