Showing XXX results across 3 categories.
The ICH E18 Guideline on Genomic Sampling and Management of Data reached Step 4 of the ICH Process in September 2017 and now enters into the implementation period (Step 5).
The ICH Q11 Q&A reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5).
The ICH S5(R3) on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.
The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.
At the Osaka 2016 meeting, the ICH Management Committee endorsed a Pilot Programme for 2017 in which the ICH Training Subcommittee would partner with a small group of training providers.
In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide harmonised guidance on when a targeted approach to safety data collection would be appropriate.
At the ICH meeting in Montreal, Canada, on 27 May to 1 June 2017, the ICH Assembly and ICH Management Committee made some revisions to the Articles of Association, Rules of Procedure and Standard Operating Procedures for Working Groups.
The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5).