Discover Insights on ICH GCP E6(R3) from the SCOPE Summit 2023

The clinical research community is eagerly anticipating the release of the third version of the ICH Good Clinical Practice (GCP) guideline, ICH E6(R3). Our CEO, Artem Andrianov, recently returned from the SCOPE Summit in Florida and was impressed by the developments surrounding the updated guideline. In this post, we will share his observations and insights on the upcoming ICH E6(R3).

ICH’s Focus on Technology and Innovation

The ICH community is committed to incorporating the latest technological advancements and innovative clinical trial designs into the updated guideline. ICH E6(R3) will reflect this commitment while maintaining its focus on protecting human participants and ensuring reliable evidence generation.

Public Input and Stakeholder Engagement

The ICH management committee is actively involved in evaluating new topics and revising existing guidelines. The work-in-progress draft version of the principles for ICH E6(R3) is already public, and further engagement with academic experts and the wider public will continue as the guideline evolves.

The Importance of Quality by Design in Clinical Trials

Quality by design is a critical aspect of ICH E6(R3), focusing on proactively designing quality into the study protocol and processes. This involves a prospective, multidisciplinary approach to promoting the quality of protocol and process design and clear communication of how this will be achieved.

Risk-Based Approaches

In addition to quality by design, ICH E6(R3) also emphasizes the importance of considering risk-based approaches when implementing measures to ensure GMP and the appropriate shipping and handling of investigational products.

In conclusion, the clinical research community is eagerly awaiting the release of ICH E6(R3) and its updated approach to clinical trials. By incorporating the latest advancements in technology and promoting quality by design, we can work together to bring the best quality to our clinical trials. Stay tuned for further updates on ICH E6(R3), and let us continue advancing the clinical research field.

  • To stay ahead of the curve and familiarize yourself with the changes coming in ICH E6(R3), be sure to review the current work-in-progress draft version released by the ICH management committee here…