Two-Day Web Conference on ICH E6 Guideline for Good Clinical Practice

Thursday, June 4, and Friday, June 5, from 10:00 a.m. – 1:00 p.m. EDT

Free public web conference organized by the U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, on the International Council for Harmonisation (ICH) Good Clinical Practice guideline (ICH E6). The goal of this Pan-American-focused public web conference is to listen and learn from stakeholders, particularly clinical researchers and patients, about their experiences with ICH E6(R2).

Register here: https://events.r20.constantcontact.com/register/eventReg?oeidk=a07eh2l805x801dbf3f&oseq=&c=&ch=

The web conference, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” will help enrich the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the ICH E6(R2) guideline. Stakeholder feedback may also enable the EWG to develop an updated guideline that is responsive to the needs of individuals conducting or participating in clinical trials. 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. 

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. Meeting details are available on the FDA’s website.

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