Day One: Tuesday, 21 October, 2025Tuesday, 21 October 2025 - CET (Central European Time, GMT+01:00)

Step into the world of clinical trials through the eyes of the patients themselves. This powerful session brings authentic patient stories, insights, and trial experiences to the forefront of clinical research. This highlights: 

• Testimonials and experiences from trial participants highlighting challenges and positive outcomes 

• How clear information and support throughout trial process can influence patient engagement and satisfaction

Stay on the pulse of regulatory requirements with a forward-looking analysis of the EHDS Regulation and its impact on clinical trial transparency. Explore ways this new framework will data sharing requirements by:  

• Analyse the extent of data sharing under this new regulation 
• Assess its impact on overall clinical trial transparency  
• Implement timeline and preparation strategies for EHDS adoption 

Navigate the transformative journey of clinical trial transparency from its regulatory origins to today's comprehensive disclosure landscape. This session explores how pharmaceutical companies have adapted to increasing disclosure requirements while balancing scientific integrity with confidentiality concerns.

• Understand the historical context and future direction of disclosure regulations to better position your organization for compliance
• Learn effective approaches to building internal transparency teams and processes from industry experience
• Discover balanced strategies for managing sensitive data disclosure while meeting regulatory requirements in both EU and US contexts

Navigate the complexities of CTIS with expert insights needed to face the evolving requirements of the centralised EU clinical trial platform as we explore:  

• Operational challenges where older practices meet new regulations  
• Connect with different member states to overcome inconsistencies. 
• Navigate RFIs from regulatory authorities 

Explore the strategic measures in incorporating transparency into the trial design life cycle with real-world experiences at Novartis by:

• Defining strategies for easier transparency implementation including use of Artificial Intelligence
• Identifying challenges and staying abreast of clinical transparency regulations
• Enhancing cross-functional coordination strategies
• Establishing critical decision checkpoints for transparency integration

In response to an increasingly complex regulatory landscape, organizations must adapt their internal operations to ensure compliance while maintaining efficiency. Discuss comprehensive strategies for managing day-to-day protocols.  

• The rise of Gen AI in biopharma – From early chatbots to advanced autonomous agents, with a focus on clinical trial transparency
• Workflow automation and orchestration – How AI agents manage both discrete transparency tasks and complex multi-step processes at scale
• Real-world applications – Live demo of AI agents in action enhancing end-to-end workflows

• Discover how implementing health literacy principles across clinical research touchpoints, from informed consent to plain language summaries, can transform patient experiences and study outcomes
• Learn practical strategies for breaking down organizational silos to create consistent, accessible communications that meet regulatory requirements while truly connecting with participants
• Explore how transparent, plain-language approaches benefit everyone involved in clinical studies and position your organization to better meet patient needs in an increasingly regulated environment

The UK’s clinical trial regulations are changing. In this session, the Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) will share updates on:

• Why and how the regulations are changing
• New guidance to support amended regulations
• Specific changes to research transparency requirements, including trial registration, publishing results and sharing results with trial participants