Day Two: Wednesday, 22 October, 2025Wednesday, 22 October 2025 - CET (Central European Time, GMT+01:00)

AI has the potential to streamline the drafting of PLS. The technology and its application in PLS continue to advance with organizations across clinical research exploring – if not implementing - its use. Yet, more concerns and questions are raised on responsible use of AI for PLS than practical insights and case examples towards consensus driven practices for integration. Representatives of the working group that published the “Considerations for Use of AI in PLS” consider the path forward including the conditions that may be needed for broad adoption and sharing key learnings and insights from the public comment period that preceded their publication. 

• Getting internal stakeholders to understand redactions space and find balance between over and under redaction 
• Understand what is and isn’t confidential information and meeting regulatory CCI standards 
• Implementing internal trainings for internal CCI teams  
• AI automations in CCI to streamline manual processes 
• RFI response rate and audit trails 

• Optimize your anonymization strategy by leveraging insights from hundreds of successful marketing authorization applications, allowing you to align with industry best practices while maintaining data utility
• Enhance regulatory compliance through understanding the different approaches to company confidential information (CCI) across EMA and Health Canada submissions, reducing approval delays and potential disclosure risks
• Improve data utility preservation by implementing evidence-based anonymization techniques that balance privacy protection with maintaining scientific value, as demonstrated through real-world case studies

• Explore regulatory timelines, resource allocation strategies and technology solutions that enable timely development of high-quality lay summaries while maintaining scientific accuracy and patient accessibility  
• Examine different production models, development methodologies and stakeholder involvement strategies to determine optimal approaches for various organisational context 
• Learn from Novartis' systematic approach to lay protocol synopsis development, including their end-to-end process, quality control measures and key lessons that have enhanced their timeline adherence and output quality 

This interactive roundtable session brings together disclosure and transparency professionals to explore organizational challenges and strategic approaches in clinical trial transparency. Through live polling and guided discussion, participants will examine how disclosure functions are structured within organizations, methods for measuring and demonstrating transparency value, and change management strategies for navigating new regulations like EHDS and recent CT.gov impacts. The session focuses on practical challenges including cross-functional stakeholder education, strategic resource allocation, and developing actionable frameworks for responding to the rapidly evolving regulatory landscape.