April 27, 2021
Pharmaceuticals and Medical Devices Agency
The International Council for Harmonisation (ICH) E6 (R3) Expert Working Group (EWG) is working on the revision of the ICH E6 (R2) Guideline “Guideline for Good Clinical Practice (GCP)”.
ICH E6 Guideline is the international ethical, scientific, and quality standard for the conduct of clinical trials for the development of new drugs etc., involving human participants intended to support regulatory applications.
The ICH is holding a free public web conference to provide an update on the progress of revising this important and impactful guideline.
In this web conference, members of the EWG will discuss the work-in-progress to develop updated version of principles and Annexes for ICH E6 GCP. In addition, the web conference will include presentations from stakeholders that greatly enriched the discussions of the EWG on their vision and aspiration for clinical trial design and conduct.
In advance of the public web conference, the draft, work-in-progress principles were published by the ICH. View the principles on the ICH website at [https://database.ich.org/sites/default/files/ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf].
The EWG is not taking public comments on the principles at this stage. However, once the ICH E6 (R3) guideline achieves step 3 of the ICH guideline development process, the EWG will invite and consider public input.
Day 1 Tuesday, May 18, 2021 21:00-24:00 JST
Day 2 Wednesday, May 19, 2021 18:00-21:00 JST
The same topics will be presented each day in different time zones to reach a broad global audience.
Please register through the following website. (Available only in English)
Note that registration information must be submitted in English.
Registration can be made until the day of the web conerence.
There is no registration fee for this web conference.
Day 1 (May 18) https://duke.zoom.us/webinar/register/WN_6MVjr6qsQxSgYrCuJ-6Xyw
Day 2 (May 19) https://duke.zoom.us/webinar/register/WN_OzK4XPh_Shq-XniAxpKKJw
For more information on the web conference, please see the following ICH website. (Available only in English)
Public Web Conference Organized by the ICH E6 (R3) EWG
Agena will be made available shortly.