Our own SAM Sather will be in the ACRP's Northern California chapter for a discussion of the guideline updates, impact assessment, and a scalable approach to implementation of ICH-GCP E6 R2. For more information click here.
Part of the discussion will be the purpose of ICH-GCP E6 which:
• Provides unified standard for: European Union, Japan, United States, Canada, and Switzerland
• Facilitate mutual acceptance by the regulatory authorities of data from clinical trials.
There will be a focus on ICH-GCP E6:
• Updating and clarifying standards for electronic records and essential documents
• Encourage sponsors to implement improved oversight and management of clinical trials
• Facilitate innovative approaches (QRM, QbD, technology) to clinical trials
Join us for a stimulating presentation that analyzes the new guideline.
-The Clinical Pathways Team