International Council for Harmonisation (ICH) first time since 17 years is undertaking ground-shaking changes to Good Clinical Practice (GCP) guidelines. These changes take effect on November 1, 2016.
In the 22 minute video above it is described how the new upcoming ICH GCP Addendum E6 (R2) will influence clinical trials.
We encourage all guests of our web-site to watch this 22-minute video explaining the main purpose of the Integrated Addendum and each of the changes being proposed.
Besides, feel free to download our poster with GCP E6(R2) addendum Mind Map and read the reflection article “ICH GCP Goes Risk-based” (By Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD) published by AppliedClinicaTrials in October 2015.