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 

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 

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

• 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 

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