Webinar: How to Make Your Organization ICH E8 (R1) Ready

Tuesday, June 28, 2022  |  11:00am – 12:00pm EDT

Effective April 2022, ICH E8 R1 brings an enhanced focus on Quality by Design, are you prepared?

ICH E8 R1 was made effective on April 14, 2022. Per ICH.org, the revision proposes to (1) identify a basic set of critical-to-quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of trial results and to protect human subjects; (2) address a broader range of trial designs and data sources; (3) provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies.

The guidance encourages up front preparation and risk assessments that incorporate external parties such as patients, investigators, site staff and caregivers to ensure the design meets quality standards across multiple stakeholders. To be fully compliant with this guidance, it is expected that many organizations will have to adjust their current processes and embed more time into the study planning phase. While the initial impact may be an increased start-up time, the downstream affects if done correctly are positive in that it is expected to decrease the number of protocol amendments and increase quality across a trial.