C01 – Implementation and Application of ICH GCP E6 R(2)

ICH-GCP guideline was updated in 2016 and has come into effect on 14 June 2017. Since the original version of ICH E6 R(1) was prepared in 1996 the scale, complexity and cost of clinical trials has increased. Essentially moving from paper-based to electronic data recording and reporting.  The authors of the update state that “this guideline has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.” This session will cover the background to ICH GCP and provide an overview of the changes.

In addition to the plenary on day 3, attend the ARCS and DIA Application of ICH GCP E6 (R2) workshop for investigational sites and sponsor representatives workshop (25 August) in Sydney.  A more detailed summary of the addendums will be presented along with hands-on case study driven training on the update.

Chairperson: Katrina Harrison, Country Clinical Quality Manager (ANZ), MSD Global Clinical Trial Operations (GCTO)