JUNE 04, 2020 TO JUNE 05, 2020
CTTI Project: Informing ICH E6 Renovation
Meeting Overview:
The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, is organizing a free two-day Pan-American-focused public web conference on Thursday, June 4, and Friday, June 5, from 10:00 a.m. - 1:00 p.m. EDT, to learn more about stakeholder experiences with the International Council for Harmonisation (ICH) Good Clinical Practice guideline (ICH E6).
This stakeholder engagement web conference will inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Members of the EWG will provide an overview of the ongoing work to update the guideline and will then hear from multiple stakeholders on their experiences with ICH E6(R2).
The registration process gives registrants an opportunity to submit questions. We will address themes from questions submitted before Tuesday, May 26, during a session on Friday, June 5. Please note the following regarding submissions:
- Submissions must be in English.
- Anyone can submit questions or comments.
Time slots for stakeholders to provide oral comments during the second day of the web conference are now filled. Please consider submitting questions when registering or sending written comments to cttievents@dm.duke.edu (External Link Disclaimer).
For additional information on the ICH E6 revision efforts, please refer to the following materials:
- ICH E6 main page (www.ich.org)
- ICH E6(R3) Concept Paper
- Summary of the ICH E6 engagement proposal
- CTTI's ICH E6 Renovation Work
Meeting details are available on FDA’s website.
Meeting Materials:
Day 1
Session I: Introduction/ICH Process & Updating ICH E6 GCP Guidelines
Session II: CTTI ICH E6 Survey and Stakeholder Input
Session III: Perspectives from EWG Members
Session IV: Perspectives from Clinical Investigators
Session V: Perspectives from Patient Organizations
Day 2
Session I: Stakeholders Perspectives
Session II: Moderated Discussion of Themes from Stakeholders
Session III: Stakeholder Comments
The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.