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.

Presenter: Karen Harvey Senior Director, Avoca Quality Consortium Avoca, A WCG Company

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.

Speaker: Brian Barnes Director, Governance Excellence & Risk Management BioNTech

From AI Curiosity to Inspection-Ready Quality Intelligence: Practical GenAI Practices for Clinical Development

Presenter: Corey Alexander Global Head CQA Technologies, Innovation, and Operations Novartis

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.

Presenter: Jonathan Rowe Senior Consultant AQC

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.

Presenter: Jonathan Rowe Senior Consultant AQC

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).