While the ICH E6 addendum, (R2), is already in force in Europe, the FDA has yet to publish the final guidance here in the U.S. Sponsors and CROs alike have been evaluating, discussing and generally worrying about how to prepare for this guidance. The draft guidance sets out some key areas to focus on, but every pharmaceutical company must make considered decisions as to how to align their processes and automation with the guidance.
Tips for Operationalizing the ICH E6 (R2) Guidance Print
Created by: Brian Lederman
Modified on: Tue, 9 Feb, 2021 at 12:56 PM
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