| Wednesday, September 30, 2026 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 10:00 AM - 2:00 PM (EDT) | ICH E6(R3), Quality by Design, and AI: Framing Innovation Through a Risk-Based Lens How ICH E6(R3) principles should shape AI implementation, ensuring AI-enabled processes support quality, risk management, oversight, and participant protection.
Building AI Into the Foundation: Governance, Integration, and Sustainability Practical approaches for embedding AI governance into existing quality and operational frameworks, including sustainability considerations and regulatory expectations.
From AI Curiosity to Inspection-Ready Quality Intelligence: Practical GenAI Practices for Clinical Development
Interactive Workshop Part 1: Applying AI to Protocol Design: A CTQ Identification Challenge Participants review a protocol and identify CTQs and related risks. Discussion focuses on how AI can support protocol design, risk identification, and quality-by-design principles while maintaining appropriate oversight and accountability.
Lunch Break Interactive Workshop Part 2: Applying AI to Clinical Trial Processes: Risk, Oversight, and Gap Identification Participants evaluate key clinical trial processes through an RBQM and oversight lens to identify process gaps, control weaknesses, and systemic risks. Discussion explores where AI can enhance efficiency and detection while supporting quality outcomes and inspection readiness.
Joint Closing Session Connecting the Dots: From Protocol Risk to Process Execution Teams share findings from both exercises and discuss how CTQs, protocol-level risks, process controls, oversight activities, and AI-enabled insights work together to support quality and compliance under ICH E6(R3).
• Corey Alexander, MBA - Global Head CQA Technologies, Innovation, and Operations - Novartis • Brian Barnes - Director, Governance Excellence & Risk Management - BioNTech • Karen Harvey - Senior Director, Avoca Quality Consortium - Avoca, A WCG Company • Jonathan Rowe, PhD, MS, MA - Senior Consultant - AQC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
