ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials

Summary:

Health Canada is announcing a public meeting, being hosted by the U.S. Food and Drug Administration, entitled "ICH Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials". The purpose of the public meeting is to provide information and solicit input from a broad range of non-ICH Member/Observers stakeholders on the draft revised E8(R1) Guideline "General Considerations for Clinical Trials" (available in English only).

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. A wide 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 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.

In May 2019, the E8(R1) draft Guideline was released for public consultation, and in line with the ICH Reflection Paper on GCP Renovation, 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 addressed and permit an essential modernization of this foundational guideline.

Date:

October 31, 2019

Time:

08:30 a.m. to 5:00 p.m. ET

Location:

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.)

Agenda:

For the agenda, please visit the ICH website. (available in English only)

Registration:

If you wish to attend the public meeting either in-person or via webcast, registration is to be completed online. (available in English only)

Further information is available on the FDA event website.

Contacts:

For more information, please contact the Health Canada ICH Coordinator at hc.ich.sc@canada.ca.

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