DIA 2026 Global Annual Meeting

DIA 2026 Global Annual Meeting

8:00am EDT

#400: Hidden Potential: Turning Today’s Science into Tomorrow’s Cures Ballroom AB

11:00am EDT

#406: Enhancing Regulatory Collaboration through Cloud Technologies 111AB #415: Regulatory Cooperation Between the United States and Japan 115C #416.1: International Regulatory Cooperation with the African Medicines Agency 110A #416: Transforming Women’s Health Science: Closing the Innovation Gap and Accelerating Impact 204AB #413: Health Canada Town Hall 112AB #414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency 115AB #412: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis 201AB

2:30pm EDT

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA 203AB #439: Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty 115AB #440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines 115C #442: The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, MHRA, and PMDA 204AB #438: A Conversation About Quality: A Global Regulators Discussion 201AB

4:00pm EDT

#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration 108B #448: Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness 109AB #456: Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities 112AB #454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children 201AB #455: Japan Town Hall 115AB #457: Understanding the Misconceptions and Myths around Surrogate Endpoints 204AB

8:00am EDT

#500: Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies 114

10:15am EDT

#505: Agility Unlocked: How Mixed FSP/FSO Models Enhance Efficiency and Facilitate the Transition from FSO to FSP Outsourcing 108A #513: Advancing Chronic Disease Development: Insights from FDA, EMA, PMDA, and MHRA 201AB #509: Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development 109AB #511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate 203AB #516: Modernizing Nonclinical Safety Assessment: FDA and EMA Roadmaps to Reduce Animal Testing 115C #517: Navigating the New FDA: Insights from Former FDA Chief of Staffs 204AB #519.1: European Integration in Times of Geopolitical Crisis: Supporting Ukraine’s EU Accession and Building Resilient Public Institutions 105AB #514: Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients 115AB

1:45pm EDT

#537: EMA Town Hall 204AB #538: Innovations in Drug Review: A Global Perspective 201AB #540: Regulators Approach to Address Drug Shortages 115C #541: Taiwan Town Hall: Strategies to Promote Medicine Supply Resilience 112AB #539: Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication 115AB

4:15pm EDT

#550: Evolving Artificial Intelligence Regulatory Landscape in Drug Development Across US and EU 109AB #552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate 105AB #553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success 203AB #554: Reverse Pitches: How Pharma Actually Buys 103A #556: Access Consortium Town Hall 201AB #557: Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation 115AB #560: Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment 119AB #559: China Town Hall 202AB #558: Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation 115C

8:00am EDT

#600: From Breakthrough to Life: Engineered T-Cells, Patients, and the Future of Biotech 114

10:15am EDT

#607: Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies 115AB #608: Can You Complete Your Submission in 10 Weeks? 202AB #614: Indonesia Town Hall 2026 112AB #615: Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact 204AB #612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice 102AB #613: FDA Rare Disease Town Hall 201AB

1:45pm EDT

#633: Advancing Biosimilar Development: The EU Tailored Clinical Approach and Global Harmonization Efforts 118C #635: MHRA Town Hall 119AB #636: The Next Frontier: Autoimmune Cell and Gene Therapy, Regulation, and Patient Access 201AB #634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes 115AB

4:00pm EDT

#652: Anvisa Townhall - From Backlogs to Breakthroughs: Building a Smarter Regulatory Future 107AB #655: Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts 201AB #656: Singapore Town Hall 112AB #653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle 115AB #654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation 116

8:00am EDT

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision 109AB #707: EMA - FDA Question Time 114 #708: Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22 102AB

9:30am EDT

#712: FDA Town Hall 114

11:00am EDT

#713: No More Incremental Change: The Radical Future of Healthcare 114

DIA 2026 Global Annual Meeting

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