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FDA to Organize Two-Day Web Conference with CTTI to Gather Feedback from Stakeholders to Update ICH E6 

The International Council for Harmonisation (ICH) is revising ICH E6 Good Clinical Practice (GCP) and requests stakeholder feedback to inform the process. The U.S. Food and Drug Administration, in collaboration with CTTI, will help connect the issues by organizing a free two-day public web conference for discussion of ICH E6 on Thursday, June 4, and Friday, June 5, from 10:00 a.m. - 1:00 p.m. EDT.

 

This public web conference, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” will help the ICH Expert Working Group (EWG), which is tasked with updating this guideline, learn from stakeholder experiences with the current GCP guideline (ICH E6(R2)). The conference will also allow the EWG to reflect on the guideline’s applicability to the changing clinical trials landscape. Topics for discussion will include:

 

  • Experiences with applying the current guideline to clinical trials
  • Applying GCP to innovative trial designs
  • Digital technology tools and GCP
  • Other topics relating to GCP

This stakeholder engagement web conference will help inform the discussions of the EWG as the group works on developing a responsive updated guideline. Members of the EWG will provide an overview of the ongoing work to update the guideline and will subsequently hear presentations 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 question 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 see the ICH E6(R3) Concept Paper and other materials at www.ich.org. Meeting details are available on FDA’s website.

 

Register today