Impacts to RBQM and Monitoring of ICH GCP E6 (R3) and EMA Guideline Updates

Event Date: 1st August 2023

Event Time: 10:00am EDT/3:00pm BST

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Date: August 1, 2023

Time: 10:00am EDT/3:00pm BST

Version R3 of the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guideline is now available for public consultation. The update is to address the application of GCP to new trial designs, technological innovations and to strengthen a proportionate risk-based approach of its application for clinical trials of medicines to support regulatory and healthcare decision making.

During this webinar, we will explore the key changes and new text in Version R3 as it relates specifically to monitoring and RBQM. In addition, we will discuss updates to the EMA Guideline regarding computerized systems and electronic data in clinical trials. Finally, we will share how to create compliant procedures in accordance with the updated guidelines.

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