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

With the recent UK clinical trial regulations, examine the impact of recent amendments to provide guidance for sponsors and stakeholders. This in-depth discussion covers:  

• Critical preparation steps for sponsor companies 
• Impact of combined review system on disclosure and transparency protocols 
• Updated trial registrations procedures and requirements for results summaries  

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 

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

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 

• Establish critical decision checkpoints for transparency integration 
• Define clear documentation protocols and creating standardised reporting templates 
• Enhance cross-functional coordination strategies 
• Develop comprehensive data collection procedures 
• Stay abreast of clinical transparency regulations 

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

Wondering what’s next for IDMP in Europe? Want to get the lowdown on the latest regulatory initiatives? Or interested in how industry can get involved in more upcoming projects? Take the chance to get your burning questions answered from our panel of regulators