Keeping up with Regulations: Good Clinical Practice ICH E6(R2)

For over 20 years, the Good Clinical Practice Guidance document ICH E6 (R1) has been the guiding star for the conduct of clinical studies to ensure data integrity and patient safety. Since the ICH E6 (R1) was finalized in May 1996, the industry has changed from largely paper-based to electronic records, and clinical studies have become larger and more complex. With the shift to risk-based quality management, a need arose to modernize and update the GCP guidance. This webinar provides an overview of the changes in the ICH E6(R2) integrated addendum, including the new additions to the glossary of terms defining a Certified Copy, Monitoring Plan and Validation of Computerized Systems.

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