ICH GCP Addendum Mind Map

The pharma world is expecting a new regulatory “earthquake”. GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as “game changing”. Clinical trial design, conducting, oversight, recording and much more is added now to GCP.

Let us review the main points.

For better understanding what new sections were added in the Addendum, Cyntegrity offers a Mind Map (Updated, VER. 3.0), which categorizes and simplifies the new information (download the PDF):

Download here as PDF.

By Artem Andrianov, Ph.D., MBA|2024-09-11T17:04:38+02:00September 10, 2015|Blog, Free Infographics, Good Clinical Practice|1 Comment

About the Author: Artem Andrianov, Ph.D., MBA

Professional in the integration of data-driven Risk-based Quality Management (RBQM) process in international clinical trials of pharmacology. Speaker at regional and global conferences such as: DIA, Health 2.0, DGGF, etc. 18+ years of experience in data quality projects and biostatistics for the pharmaceutical industry. Life passion: improving clinical research with RbM, driving the RBQM research to new frontiers for CROs, pharma and biotech companies.