The International Council for Harmonisation (ICH) is announcing a public meeting entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials.” The meeting will be hosted by the US Food and Drug Administration. The purpose of the public meeting is to provide information and solicit input from a broad range of non-ICH Member/Observer stakeholders on the draft revised E8(R1) Guideline “General Considerations for Clinical Trials.”
In January 2017, the ICH Assembly endorsed the ICH Reflection Paper on Good Clinical Practice (GCP) Renovation: Modernisation of ICH E8 Subsequent Renovation of ICH E6, further to which ICH initiated a revision of the E8 Guideline to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.
The first version of the ICH E8 Guideline was adopted in 1997 and sets out general principles on the conduct of clinical trials. Since its finalisation, clinical trial design and conduct have become more complex, impacting the time and cost required to develop drugs. An increasingly wider range of both trial designs and data sources play a role in drug development and are not adequately addressed in the original E8 Guideline.
In May 2019, the E8(R1) draft Guideline was released for public consultation, and as part of the consultation process and in line with the ICH Reflection Paper on GCP Renovation, ICH will hold public meetings before the finalization of the revised E8 Guideline. This will allow important concerns expressed by stakeholder groups, not represented in ICH, to be further discussed and feed into the essential modernization of these foundational guidelines.
Agenda:
You can find the agenda on the FDA event website here: https://www.fda.gov/media/129127/download.
Registration:
If you wish to attend the public meeting either in-person or via webcast, a registration request must be submited via this website. Registrations may be limited, so early registration is recommended. Registration is free and will be on a first-come, first-serve basis. However, the number of participants from each organization may be limited based on space limitations. Registrants will receive confirmation once they have been accepted. For additional information on traveling to the FDA headquarters, (e.g. local airports, directions, and hotels) please see the following website: https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus.
Special Accommodations:
If you need special accommodations due to a disability and/or need more information regarding this meeting, please contact William Lewallen no later than Oct 24, 2019, via email at William.Lewallen@fda.hhs.gov.
Contacts:
For more information, please contact Amanda Roache at Amanda.Roache@fda.hhs.gov.
