Keeping up with Regulations: GCP ICH E6(R2) Feb 2018 Integrated Addendum

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Keeping up with Regulations: Good Clinical Practice ICH E6(R2) Feb 2018 Integrated Addendum

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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. ICH E6(R2) was finalized in February 2018.

MWA Consulting, Inc. will provide 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.

This webinar will also cover the changes to Investigator responsibilities related to delegated functions, and Sponsor responsibilities for quality management and a risk-based approach and new requirements related to Essential Documents. This training provides an opportunity for you to keep up with changes and stay current with industry guidance and regulations.

Join us on Wednesday, Nov 13, 2019,10:30 AM PST for our global webinar.

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Dial-in number (US): (712) 770-4010

Access code: 587569#

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Online meeting ID: lisa271

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