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  4. Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice Web Conference - 06/04/2020 - 06/05/2020
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Virtual

Event Title
Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice Web Conference
June 4 - 5, 2020

Organized by FDA in Collaboration with the Clinical Trials Transformation Initiative (CTTI)


Agenda, Presentation Slides and Recordings

Meeting Agenda (PDF - 192)

Presentation Slides and Recordings

Meeting Location: Virtual 

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.

For additional information on the ICH E6 revision efforts, please see the Reflection Paper on Renovation of Good Clinical Practice and the Concept Paper. For further information on the engagement approach, please see the published outline of the ICH E6 engagement proposal.

Register for the web conference.

Note that we will use Zoom for the web conference; check with your IT services in advance to make sure you can access Zoom.

Federal Register Notice / Vol. 85, No. 99

 

 

 

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Event Materials

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