Panel
ICH E6 (R3) and the Data Revolution: Are You Ready?
Mon, Sep 29, 2025 · 5:15–6:15 PM EDT Ballroom I-II, Baltimore Convention Center
About this session
Session chaired by Tanya du Plessis
Description:
The transition from ICH E6 (R2) to ICH E6 (R3) marks a pivotal shift in clinical trial oversight, emphasizing risk-based quality management, digital data integration, and decentralized trial methodologies. As clinical data management (CDM) teams navigate this transformation, we must rethink traditional approaches to data collection, validation, and monitoring. This panel discussion brings together industry experts, regulators, and technology leaders to explore how ICH E6 (R3) is redefining CDM practices. Key topics will include:
- Risk-Based Data Quality Management: Moving beyond traditional methodologies to proactive, risk-based monitoring strategies including all departments.
- The Role of Technology: Leveraging eSource, AI-driven analytics, and decentralized data collection for improved efficiency and compliance.
- Data Integrity and Regulatory Expectations: Understanding how ICH E6 (R3) aligns with evolving global regulatory frameworks.
- Practical Implementation: Real-world strategies for adapting CDM processes, training teams, and ensuring seamless adoption.
Join us for this dynamic discussion to uncover actionable insights and prepare your organization for the next era of clinical data management. Whether you're a clinical data leader, sponsor, CRO, or technology provider, this session will equip you with the knowledge to embrace ICH E6 (R3) with confidence.
Speakers
-
VP, Global Head, Clinical Data & Information Sciences – Oncology · Pfizer
Speaker
-
Associate Director for Clinical Policy, Division of Clinical Compliance Evaluation, OSI, Office of Compliance, CDER · U.S. Food and Drug Administration
Speaker
