The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) begin revisions to ICH E6 Good Clinical Practice (GCP). New research by the Clinical Trials Transformation Initiative (CTTI) highlights opportunities for changes and improvements. These are the agreed upon industry standards that help shape how clinical trials are conducted.
An Important Agenda
Presenters will discuss CTTI’s multi-method research to 1) identify areas within ICH E6 GCP that are in the greatest need of renovation, 2) suggest realistic ways for renovation, and 3) describe stakeholder experiences with implementing ICH E6 GCP. The research includes the perspectives of more than 350 research professionals in 20 different global regions.
An impressive group of speakers include:
· Fergus Sweeney (EMA)
· Celia Witten (FDA, CBER)
· Amy Corneli (CTTI)
· Dagmar Gortz (Janssen)
· Pamela Gonzalez (University of Chicago)
An Important Organization
The CTTI is a public-private partnership to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. With more than 80 member organizations, including government agencies such as the FDA Centers for Medicare and Medicaid Services, Offices of Human Research Protections, National Institutes of Health, and other national and international bodies, the organization offers a unique combination of industry interest, point of view, and perspective—grounded in a pragmatic yet strategic lens.
Call to Action: For those clinical trial operation professionals keen on keeping up with ICH changes, the webinar should be high on the agenda come March 19th. See the link to the webinar here.Source: Duke Medicine