Showing XXX results across 3 categories.
To facilitate the implementation of ICH Guidelines and other documents, the ICH website gets updated regularly with new training material.
ICH MedDRA Management Board Notes New MedDRA Tools Supporting Multiple Languages.
Implementation Working Groups (IWGs) have been set up for the ICH topics S3A, S9 and Q11 with a mandate to develop Question and Answer (Q&A) documents to clarify specific aspects of these Guidelines.
The ICH M8 electronic Common Technical Document Implementation Guide (eCTD IG) reached Step 2b of the ICH Process in February 2015 and now enters the consultation period (Step 3).
On 13 April 2015, the Drug Information Association (DIA) in collaboration with the European Commission (EC) and the European Medicines Agency (EMA) are organising an “Information Day on ICH”.
To facilitate the implementation of ICH Guidelines and other documents, the ICH website gets updated regularly with new training material.
A comprehensive report of the last ICH meeting that was held in Lisbon, Portugal on 12-13 November 2014 is now available on the ICH website under the SC Reports page.
In November 2014, the ICH E2B(R3) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers which intends to clarify specific issues identified since the ICH E2B(R3) Guideline was published in the ICH Regions.