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• Agenda

The International Council for Harmonisation (ICH) members, including the U.S. Food and Drug Administration, the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Association, will hold a free public web conference on May 18 and 19 to provide a status update on revisions to the ICH E6 Guideline for Good Clinical Practice.

During the web conference, the ICH E6 Expert Working Group (EWG) will give an update on its work to develop principles and annexes for ICH E6 GCP [third version or E6(R3)] that aim to be responsive across clinical trial types and settings and to stay relevant as technology and methodologies advance. The EWG is not taking public comments on the principles at this stage. However, once the ICH E6 guideline moves to step 3 of the development process, the EWG will invite and consider public input.

At the conference, the EWG will also discuss its plans and approaches to update the guideline more generally, including its engagement efforts with stakeholders.

This conference will consist of two similar meetings on May 18 and May 19 that will be held by the EWG and convened by the Clinical Trials Transformation Initiative (CTTI). The EWG decided to hold two meetings to reach a broad global audience across time zones. Individuals do not need to attend both days of the conference, although they are welcome to do so. 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.

Register

To register and receive a link to the meeting, individuals should select the date that they plan to attend. As mentioned, they can attend both days, but it is not necessary. Registration information must be submitted in English.

• Option 1: Tuesday, May 18 from 8-11 a.m. EDT (2-5 p.m. CEST, 9 p.m. – 12 a.m. JST)
  Day 1 Registration
• Option 2: Wednesday, May 19 from 6-9 p.m. JST (5-8 a.m. EDT, 11 a.m. – 2 p.m. CEST)
  Day 2 Registration

Individuals can also register on the days of the meetings.

Recorded presentations of the public web conference will be posted on CTTI’s website after the live sessions have taken place.