ICH E18 Guideline Reaches Step 2b of the ICH Process
The ICH E18 Guideline on Genomic Sampling and Management of Data reaches Step 2b of the ICH Process in December 2015 and now enters the consultation period (Step 3).
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The ICH E18 Guideline on Genomic Sampling and Management of Data reaches Step 2b of the ICH Process in December 2015 and now enters the consultation period (Step 3).
The revised version of the ICH E14 Questions & Answers on The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drug reached Step 4 of the ICH Process in December 2015 and now enters the implementation period (Step 5).
The Membership and Observership Application Process is now available on the ICH website.
As part of increasing the international outreach and inclusiveness of ICH, one of the first points of business was to review the application process for new Members and Observers.
Reformed ICH advances work on several key new guidelines.
ICH MedDRA Management Board Notes New SOC and New SMQs for MedDRA Version 19.0.
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly and Management Committee on 23 October 2015.
The ICH M4E(R2) Guideline reaches Step 2b of the ICH Process in August 2015 and now enters the consultation period (Step 3).