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

Meeting Report (PDF - 210 KB)

Presentation Slides and Recordings

Meeting Location: Virtual 

Meeting Overview

The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, organized a free two-day Pan-American-focused public web conference on Thursday, June 4, and Friday, June 5, to learn more about stakeholder experiences with the International Council for Harmonisation (ICH) Good Clinical Practice guideline (ICH E6).

The purpose of this stakeholder engagement web conference was to 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 provided an overview of the ongoing work to update the guideline and then heard from multiple stakeholders on their experiences with ICH E6(R2). 

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.

Federal Register Notice / Vol. 85, No. 99

 

 

 

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Event Materials

Title File Type/Size
MeetingReportFinal.pdf pdf (209.20 KB)
ICH_E14-S7BWebinarAgenda pdf (122.70 KB)
 
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