Showing XXX results across 3 categories.
The ICH Q3D(R2) Guideline for Elemental Impurities reached Step 4 of the ICH Process in April 2022. A Step 4 Introductory Training Presentation has also been developed by the Q3D(R2) Maintenance EWG.
The International Council for Harmonisation (ICH) met on the 21 – 25 May, in Athens, Greece, for the first time in a hybrid format, with both in-person and virtual participation across the meetings of seven Working Groups, the ICH Management Committee, the MedDRA Management Committee and the ICH Assembly.
A free-text analysis report has been published on the ICH website, further to an analysis of the anonymised comments from the industry participating in the most recent implementation survey conducted in 2021.
The Model-Informed Drug Development (MIDD) Discussion Group, which was established in January 2021, has provided as an output of its discussions, considerations with respect to future MIDD related guidelines in the form of a “roadmap”.
The ICH E8(R1) Guideline on General Considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together leading regulatory authorities and pharmaceutical industry organisations to harmonise scientific and technical standards worldwide.
The ICH E11A draft Guideline on Pediatric Extrapolation reached Step 2 of the ICH process on 4 April 2022 and now enters the public consultation period.
The ICH Revision of Q2(R2) draft Guideline on Validation of Analytical Procedures reached Step 2 of the ICH process on 24 March 2022 and now enters the public consultation period.