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The ICH E18 Guideline on Genomic Sampling and Management of Genomic Data provides guidance on genomic sample collection to evaluate efficacy and safety of a drug for regulatory approval.
Following its last meeting in Montreal in June 2017, the International Council for Harmonisation (ICH) has continued to progress its work.
Following its last meeting in Montreal in June 2017, ICH has continued to progress its work with the adoption of new guidelines on pediatric clinical trials and genomic data and the publication of new draft guidance on estimands and reproductive toxicity.
The ICH revised S5(R3) draft Guideline 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 Management Committee identified the Expert & Implementation Working Groups to meet at the upcoming ICH meeting to take place in Geneva, Switzerland.
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 to deliver programmes based upon ICH Guidelines.
In May/June 2017, the ICH Assembly and Management Committee met in Montreal, Canada, for their biannual meeting.
The ICH E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5).