- June 4 - 5, 2020
10:00 AM - 1:00 PM ET
Agenda, Presentation Slides and Recordings
Meeting Agenda (PDF - 192)
Meeting Location: Virtual
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 firstname.lastname@example.org.
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.
Note that we will use Zoom for the web conference; check with your IT services in advance to make sure you can access Zoom.
|6_1_2020 DRAFT E6 (R3) Agenda Public Web Conference June 2020||pdf (192.78 KB)|