ICH GCP Addendum E6 (R2) (Explanation Video from ICH)

Source: http://www.ich.org

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.

By |2016-11-16T18:35:31+00:00July 8, 2016|Blog|0 Comments

About the Author:

Professional in the integration of data-driven Risk-based Monitoring (RbM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, PharmaForum, PharmaDay, DGGF, etc. 10+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RbM research to new frontiers for CROs, pharma and biotech companies.

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