FDA and CTTI Will Organize Web Conference on Stakeholder Experiences with ICH Good Clinical Practice Guideline (ICH E6)
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:
Stakeholders are also invited to preregister to provide oral comments during the second day of the web conference. If you would like to provide a five-minute statement, please indicate your interest when registering; the first 5-10 participants will be selected. If you cannot provide oral comments, please consider sending written comments to cttievents@dm.duke.edu. For additional information on the ICH E6 revision efforts, please see the ICH E6(R3) Concept Paper and other materials at www.ich.org. |
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