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In May 2020, the ICH Management Committee and the ICH Assembly both held virtual meetings for their bi-annual meetings.
The ICH M7 Q&A draft document reached Step 2b of the ICH Process in June 2020 and now enters the consultation period. Additionally, a Step 2 Informational Presentation has also been developed by the M7(R2) Maintenance EWG/IWG.
The ICH M7 Q&A document on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” reached Step 2b of the ICH Process on 29 June 2020 and now enters the consultation period.
Following the adoption of the ICH S5(R3) Guideline, a Step 4 Introductory Training Presentation has been developed by the S5(R3) Expert Working Group in February 2020, now including a voice over.
The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.3 reached Step 4 of the ICH process in May 2020.
The International Council for Harmonisation (ICH) met virtually on 27 May, in place of the face-to-face meetings that were to take place in Vancouver, Canada.
The International Council for Harmonisation (ICH) met virtually on 27 May, in place of the face-to-face meetings that were to take place in Vancouver, Canada.
Further to ICH’s commitment for stakeholder engagement with academic clinical researchers and patient representatives, an approach was developed with a view to ensuring that the guidelines are responsive to the needs of those conducting or participating in clinical trials.