Public Web Conference organised by the ICH E6(R3) EWG - 18-19 May
ISCB Permanent Office
Dear all,
The following message has reached the Permanent Office earlier today. Kindly alert us to any further actions required, such as distribution through Google groups to ISCB membership.
Kind regards,
Maria
From: StakeholdersDB <Stakeho...@ema.europa.eu>
Sent: Wednesday, April 28, 2021 3:38 PM
To: StakeholdersDB <Stakeho...@ema.europa.eu>
Cc: Industry <Indu...@ema.europa.eu>; Academia <Acad...@ema.europa.eu>
Subject: Public Web Conference organised by the ICH E6(R3) EWG - 18-19 May
Dear Stakeholder,
On behalf of the International Council for Harmonisation (ICH), we would like to bring to your attention that the ICH E6 Good Clinical Practice (GCP) Expert Working Group (EWG) is holding a free public web conference to provide an update on the progress to revise this important and impactful guideline. This web conference is being convened by the Clinical Trials Transformation Initiative (CTTI) (CTTI is a public-private partnership co-founded by FDA, United States and Duke University in 2007).
The EWG is holding two similar meetings on Tuesday, May 18, 2021 (8-11 a.m. EDT) and Wednesday, May 19, 2021 (6-9 pm JST) to reach a broad global audience across time zones. As you will note on the agenda (to be made available shortly), 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 below that you plan to attend. Individuals may register to attend the meeting on both days, but it is not necessary. Please choose the time that works best for you.
• 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
When registering, please provide contact information as requested. Note that registration information must be submitted in English.
Registration will also be available on the days of the meetings.
Recorded presentations of the public web conference will be made available following the conclusion of the live sessions.
Additional Meeting Details:
ICH E6 GCP is the international ethical, scientific, and quality standard for the conduct of clinical trials for the development of new drugs and biologics involving human participants intended to support regulatory applications. Due to the wide impact of this important guideline, the ICH Management Committee is taking this unique step to provide an update on the status of the work.
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 version or E6(R3)) that are intended to be responsive across clinical trial types and settings and 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 E6 page of 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. As part of these continued efforts to engage with stakeholders, the web conference will include presentations from stakeholders on their vision and aspiration for clinical trial design and conduct that are responsive to the needs of the community.
For additional information on the ICH E6 revision efforts, please see the Reflection Paper on Renovation of Good Clinical Practice and the Concept Paper. For further information on the engagement approach, please see the published outline of the ICH E6 engagement proposal. Other materials, including the current guideline, "ICH E6(R2): Guideline for Good Clinical Practice," the business plan, work plan, an expert list, and reports of prior public engagements are available on the ICH website: https://www.ich.org/page/efficacy-guidelines
You have received this mail because you have registered in the EMA stakeholders database and subscribed to receive this kind of information. However, if you no longer wish to receive such communications from us, please send an email to Stakeho...@ema.europa.eu to unsubscribe.
We would be grateful if you could disseminate this email to anyone else who might be interested in this information.
With kind regards,
Ivana Silva
Public and Stakeholders Engagement Department
Stakeholders and Communication Division
European Medicines Agency
Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands
Stakeho...@ema.europa.eu / www.ema.europa.eu
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