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

• Examine how to effectively integrate RWD into eCTD and other electronic submission formats
• Address data standards, validation requirements, presentation struggles and regulatory expectations across different health authorities

• Explore advanced modular eCTD strategies, including intelligent model reuse and building submission libraries
• Strategies for shared modules across product families

• 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

Submission backlogs are the silent killer of regulatory operations. This roundtable is for regulatory professionals who are drowning in submission backlogs and need practical strategies to triage, prioritise and actually make progress. Hear honest discussions on what’s really causing backlogs and what actually works for them.

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.