- October 31, 2019
The Food and Drug Administration (FDA) is announcing a public meeting organised by the International Council for Harmonisation (ICH) and entitled “ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Studies.” 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 Studies.”
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.
October 31, 2019
08:30 a.m. to 5:00 p.m. ET
10903 New Hampshire Ave. Bldg 31 Conference Center, Rm. 1503 (Great Room) Silver Spring, MD 20993, USA Or Webcast (A website to access the webcast will be emailed to those who register for the meeting as a remote attendee)
The final agenda is available here: ICH E8 Stakeholder Meeting Agenda.
- Session I - https://collaboration.fda.gov/pi8arguc5qqo/
- Session II & III - https://collaboration.fda.gov/pkkuk9zf8n2t/
- Session IV - https://collaboration.fda.gov/p31e6cd3jd4d/
- Session V - https://collaboration.fda.gov/pf7i8xh2uivg/
If you wish to attend the public meeting either in-person or via webcast, please register at the following website: https://globalichmeeting_e8r1_2019_americas.eventbrite.com. 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 FDA Campus Information, (e.g., local airports, directions, and local hotels) please see the following website: https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus.
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.
For more information, please contact Amanda Roache at Amanda.Roache@fda.hhs.gov.
|ICH E8 Stakeholder Meeting Agenda 2019 1021||pdf (156.93 KB)|
|ICH Public Meeting E8R1 Public Meeting Slides - final version||pdf (2.03 MB)|