How to Make Your Organization ICH E8 (R1) Ready

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.

Attendees will:
• Understand the updates to ICH E8 which became effective in April 2022
• Understand the positive impacts that QbD approaches have on overall clinical trial execution
• Learn effective ways to modify current protocol development processes to comply with the expectations outlined in ICH E8 R1
• Learn how a “checklist” mentality decreases the effectiveness of true quality by design preparation.

01:23:00