Agenda for Day Two - Tuesday 29 September, 2026Tuesday, 29 September 2026 - CET

• Explore the latest AI applications and use cases in eSubmissions -
  • Automated document classification
  • Intelligent content extraction
  • Predictive quality checks
  • Submission readiness assessments
• Discover how machine learning models are reducing manual effort, improving accuracy and accelerating submission timelines while maintaining practicality

• Learn how TRS differ from traditional submission processes, their role in securing data sharing and their potential to facilitate early regulatory dialogue and reduce development timelines
• Get a status update on cloud submission capabilities at Health Authorities worldwide and practical insights into what cloud-based submissions mean for industry
• Explore ongoing TRS projects, such as Proof of Concepts (POCs) and discover decision frameworks for adopting cloud submissions to enhance efficiency and regulatory intelligence

• Understand the platform technology (PT) approached in the European Commission’s New Pharmaceutical Legislation (NPL) and its likely regulatory intent
• Hear first-hand experiences and real-life case studies of PT approaches implemented so far, with lessons learned and practical challenges
• Review real-life PT approaches that existed prior to the NPL proposal to identify buildable elements and proven practices
• Gain comparative insights on human v. veterinary regulatory pathways for platform technologies, noting critical differences and shared considerations
• Anticipate how platform technology provisions may evolve and adopt best-practice preparation steps (risk assessment, data strategy, governance and cross-sector coordination)

• Explore the strategic need for e-Portals and e-Labeling to reduce paper reliance, streamline promotional material updates and simplify global ad revisions
• Hear practical considerations, common roadblocks and collaboration strategies with local partners when building e-Labeling and e-Submissions platforms in emerging markets
• Compare regional deployment approaches and outline high-level strategies for implementing e-Portals across the EU, APAC and beyond

• Glean modern approaches to variations, supplements and change notifications across global markets - streamline post-approval lifecycle management
• Strategies for grouping and sequencing post-approval submissions
• Digital tools for tracking submission status and regulatory commitments

Join this facilitator-led roundtable to share practical strategies and leave with clear, actionable next steps to implement AI into your regulatory workflows. Tackle adoption challenges – ownership, fit-for-purpose governance and who are the AI-decision makers- while clarifying semantic alignment and validation guardrails for compliant AI.

IDMP isn’t just a regulatory checkbox - it's a fundamental transformation of how you structure, manage and exchange product information. This roundtable brings together regulatory operations professionals, data managers and IDMP implementation leaders who are in the trenches.