Infographic Document

Infographic – Operationalizing ICH E6 (R2)

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The International Conference on Harmonization (ICH), issued a Guideline for Good Clinical Practice (GCP) in 1996. The R2 amendment was adopted by European authorities in 2017, and the FDA has issued draft guidance that follows the same guidelines.

This Infographic summarizes and organizes what the FDA expects from ICH E6 (R2), and how to align with their guidance with Process and Automation.

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