ICH Public Meeting To Get Input From Non-Members On E8 Revision
Executive Summary
The meeting will allow the International Council for Harmonisation to further discuss the concerns non-ICH members have over its guideline that covers general considerations for clinical trials.
You may also be interested in...
ICH Plans Revamp Of Guidance On Clinical Trial Data Quality
The International Council for Harmonisation has proposed modernizing its July 1997 guideline on general considerations for clinical trials. The proposal also kick-starts the GCP renovation project, which aims to remove inconsistencies in how randomized control trials are conducted.
ICH To Fix Inconsistencies With RCTs, Address Use Of Alternate Designs And Data Sources
The International Council for Harmonisation has proposed major changes to its good clinical practice requirements in a bid to allay concerns about the problems they pose in conducting well-designed randomized trials. The revised GCP framework would also address the increasing diversity of clinical trial designs and data sources.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.