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 

• 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 

Explore the complex landscape of international reporting standards, stringent requirements, and maintaining compliance  

• Discuss guidance for essential compliance requirements versus supplementary elements 
• Navigating diverse international data protections law 
• Understand various level of compliance stringency and developing approaches to regulation harmonisation 

This session invites attendees to collaboratively explore critical gaps in clinical trial transparency and dive deeper into pressing topics discussed during the conference. Participants will identify unaddressed areas, such as post-trial data sharing, decentralized trials, and diversity reporting, while also revisiting hot topics like AI in transparency, GDPR compliance, and EHDS regulation. The discussion aims to generate actionable insights and ideas for future initiatives.