ICH E6(R3) Explained: From Regulatory Principles to Clinical Trial Practice
ICH E6(R3) represents a significant evolution of Good Clinical Practice, introducing updated principles and expectations designed to reflect the increasing complexity, digitalization, and diversity of modern clinical trials.
Date: December 2, 2026
Time: 12:00 – 1:00 PM ET
This webinar will provide an accessible overview of ICH E6(R3), explaining the rationale behind the revision, its core principles, and the key changes clinical research professionals should understand. Particular attention will be given to areas such as Quality by Design, risk-proportionate approaches, data governance, computerized systems, roles and responsibilities, and essential records.
Building on this regulatory foundation, the session will then examine what these principles mean in practice for sponsors, CROs, and research sites. Through practical examples, participants will explore how ICH E6(R3) affects the way trial documentation and data are created, managed, exchanged, and retained throughout the study lifecycle.
The session will also address how organizations can translate regulatory expectations into practical processes for document management, sponsor-site collaboration, traceability, and inspection readiness, while applying technology in a way that is appropriate to the risks and needs of each trial.
Speakers:
Rob Jones
Head of Clinical
Arithmos
Subject Matter Expert with 17 years of experience in Good Clinical Practice (GCP), including over 10 years in Essential Records and Clinical Operations, complemented by experience in product management for an eTMF solution. Currently leading Clinical Operations consulting at Arithmos as a Clinical Business Partner. Member of the CDISC TMF Steering Committee and creator of the TMF Navigator for TMF Standard Model V1.
Todd Nudelman
North America Sales Manager
Agatha Inc
Senior Business Development Executive N.A. for Agatha with a background in electronic document management systems for the life sciences industry. Experienced in software solutions for clinical, quality and regulatory documentation. Skilled in Document Management Systems, Information Governance, Business Strategy and Global Business.
This webinar is sponsored by Agatha Inc.
Note: This free session does not provide ACRP Contact Hours.