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The International Council for Harmonisation (ICH) met virtually on 18 November in place of face-to-face meetings that were to take place in Athens, Greece, and preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.
The International Council for Harmonisation (ICH) met virtually on 18 November in place of face-to-face meetings that were to take place in Athens, Greece, and preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.
Further to the ICH Q3D(R2) draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH Q3D(R2) Maintenance EWG has been finalised.
The ICH Q3D(R2) draft Guideline on Elemental Impurities reached Step 2 of the ICH process on 25 September 2020.
The ICH E14/S7B draft Q&A document on “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential” reached Step 2b of the ICH Process on 27 August 2020.
The ICH S11 Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals reached Step 4 of the ICH Process in April 2020.
The E2B(R3) User Guide v1.1 is available for download in the Implementation Package version 1.08 on the ESTRI webpage.
The ICH biannual meeting, scheduled to be held in Athens in November 2020 is cancelled.