The International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Expert Working Group (EWG) is organizing a public web conference to provide an update on the progress to revise this important and impactful guideline. The EWG is holding two similar web conferences, convened by CTTI, on Tuesday, May 18 from 8-11 a.m. EDT (2-5 p.m. CEST, 9 p.m. – 12 a.m. JST) and Wednesday, May 19 from 6-9 p.m. JST (5-8 a.m. EDT, 11 a.m. – 2 p.m. CEST) to reach a broad global audience across time zones. Per the conference agenda, the same topics will be presented each day with speakers from different regions to represent the global effort. All information and presentations will be provided in English.
To register and receive a link to the meeting, please select the date that you plan to attend. Individuals can attend both days, but it is not necessary. Please choose the time that works best for you:
When registering, please provide contact information as requested. Note that registration information must be submitted in English.
In this web conference, members of the ICH E6 EWG will discuss the work-in-progress to develop principles and annexes for ICH E6 GCP (third revision or E6(R3)) that are intended to be responsive across clinical trial types and settings and to remain relevant as technology and methodologies advance. The draft, work-in-progress principles that were made public by the ICH on April 19, 2021, are designed to be flexible and applicable to a broad range of clinical trials. View the principles on the ICH website. The EWG is not taking public comments on the principles at this stage. However, once the ICH E6 guideline achieves step 3 of the ICH guideline development process, the EWG will invite and consider public input.
The EWG will also discuss its plans and approaches to update the guideline in general and its engagement efforts with a variety of stakeholders that greatly enriched the discussions of the EWG. Recorded presentations of the public web conferences will also be posted on CTTI’s website following the conclusion of the live sessions.