Talk Outsourcing track
Beyond the CRO Contract: Sponsor Accountability and Oversight in Risk-Based Quality Management under ICH GCP E6 (R3)
Tue, Mar 2, 2027 · 4:45–5:10 PM EST Rosen Shingle Creek
About this session
As ICH GCP E6 (R3) reinforces that accountability for trial quality, participant safety, and data integrity remains with the sponsor, effective oversight of CROs and other third-party service providers has become a critical regulatory expectation. This session will explore evolving requirements for sponsor oversight within a risk-based quality management framework, including governance structures, risk identification and assessment, vendor qualification and management, performance monitoring, issue escalation, and documentation practices. Attendees will gain practical, inspection-ready approaches to strengthening oversight, enhancing transparency, fostering proactive risk management, and maintaining continuous visibility into study execution, quality, compliance, and participant protection.
Speaker
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Associate Vice President & Head, Development Centre of Excellence, Innovative Medicine · Sun Pharma
Speaker