DIA 2026 Global Annual Meeting

DIA 2026 Global Annual Meeting

1:00pm EDT

12P : Real-World Evidence for Regulatory Decision-Making: Guidance, Methods, and Case Studies TBD

8:00am EDT

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

10:00am EDT

#401 SCC: Student Case Competition Content Hub

10:15am EDT

#401.1 IT: Box Innovation Theater: From Digital Debt to Strategic Asset - Making Regulated Clinical Content AI-Ready Innovation Theater 3 #401.2 IT: Deep Intelligent Pharma K.K. Innovation Theater: Accelerate Deep Tech Impact - Mentor Japanese MD/PhDs with Agentic AI from Startup Launch to Physician-Led Trials Innovation Theater 2 #401.3 IT: IQVIA Innovation Theater: Transforming Clinical Development - Harnessing AI for Predictive Simulation and Agentic Automation Innovation Theater 1

11:00am EDT

#402: Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care? 118AB #404: Evidence-Based Insights Informing Participant Compensation Strategies 108B #403: Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution 108A #405: AI Tools in Clinical Trials: Regulatory Considerations for Radiologic and Pathologic Assessment 109AB #406: Enhancing Regulatory Collaboration through Cloud Technologies 111AB #407: The Great Debate: Using AI in Patient-Facing Materials 105AB #408: Combined Clinical Trials: A Focus on In Vitro Diagnostics 116 #410: Managing What Matters: Turning Project Decisions into Portfolio Impact in R&D and Medical 202AB #409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI 203AB #411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts 118C #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 #417: A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy 117

12:15pm EDT

#418 POS: Student Poster Session I Exchange

12:25pm EDT

#419 IT: AlphaLife Sciences Innovation Theater: AI-Powered eCTD Authoring - Faster Draft-to-Submission with AI Tool Demos Innovation Theater 2 #420 IT: CGS Immersive Innovation Theater: From 12 Weeks to 6 - How AI Transformed Compliance Training Innovation Theater 3

12:50pm EDT

#421 CH: From Siloed Data to AI Ready Insights: How HL7 FHIR Enables Health Authority Ready Interoperability Content Hub

1:00pm EDT

#422 RT: Roundtable Discussion: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts Zone B #423 RT: Roundtable Discussion: Enhancing Regulatory Collaboration through Cloud Technologies Zone A

1:05pm EDT

#424 IT: Kivo Innovation Theater: Nothing Changes Unless We Do - Implementing QMS with CRISPR Therapeutics in 52 Days Innovation Theater 2 #425 IT: Parexel Innovation Theater: The Connected Submission - How AI, Automation, and Intelligence are Changing the Regulatory Ecosystem Innovation Theater 1

1:15pm EDT

#426 SS: Spark Stage: One Small Change Spark Stage

1:30pm EDT

#427 CH: Develop Regulatory CMC Strategies to Mitigate Global Drug Shortages Risks for Marketed Drug Products Content Hub

1:45pm EDT

#427.1 SS: Spark Stage: Solve the Funding Paradox - Deploy Capital Smarter to Turn Promising Drug Candidates into Therapies Spark Stage #428 IT: Evernorth Health Services Innovation Theater: Enabling Real World Patient Reported Outcomes Collection Through Specialty Pharmacy Engagement Innovation Theater 3 #429 IT: Verily Health Inc Innovation Theater: Bridge the Evidence Gap - Integrating Consumer Wearables and Real-World Data for Continuous, Participant-Centric Insights Innovation Theater 1

2:30pm EDT

#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV 118AB #432: Industry Collaboration 2030: Head, Heart and Gut Perspectives 108B #431: Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions 108A #433: ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science 109AB #434: Next-Generation Data Standards for Real-World Data and Real-World Evidence (FHIR, Dataset-JSON, and the Road Ahead) 111AB #435: AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise 105AB #436: Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development 202AB #437: Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing 118C #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 #443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence 117 #444: Driving Efficiency in Clinical Development with Master Protocols 116

4:00pm EDT

#445: Tailoring Risk Minimization Activities to Special Populations Locally: Patient Needs, Digitalization, Global Learning 118AB #446: DIA2026-001: Co-Creating the Patient-Centric Trial Live 108A #447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration 108B #449: Study Participants Want to Know When AI is Processing Their Medical Data: Perceptions of AI and Operational Implications 111AB #448: Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness 109AB #450: Medical Writing Ted Experience 105AB #451: Race/Ethnicity, Ancestry, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes 116 #452: Mentorship Myth Busters: Moving Beyond Misconceptions 202AB #453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability 118C #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 #458: Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations 117 #459: Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias, Endpoint Alignment, Unmeasured Confounding 107AB #460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials? 203AB

8:00am EDT

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

9:15am EDT

#501 IT: Weave Bio Innovation Theater: Threading AI Throughout the Drug Development Lifecycle - An Enterprise Lens Innovation Theater 3 #502 IT: IQVIA Innovation Theater: From Insight to Impact - Leveraging Patient Experience Data Through Technology and AI Innovation Theater 1 #503 IT: Parexel Innovation Theater: Human-Centered AI - A Dual-Layer Model for Clinical Research Excellence Innovation Theater 2

10:15am EDT

#504: From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration 118AB #506: From Barriers to Bridges: Unlocking Research Potential in Primary Care 108B #507: Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation 107AB #505: Agility Unlocked: How Mixed FSP/FSO Models Enhance Efficiency and Facilitate the Transition from FSO to FSP Outsourcing 108A #515: Leveraging Federated AI and Open Data to Transform Oncology Research and Development 112AB #510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech 103A #513: Advancing Chronic Disease Development: Insights from FDA, EMA, PMDA, and MHRA 201AB #508: How Standardized Protocol Data Plus AI Power Patient Centric Studies 111AB #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 #512: Enhanced Analytical Procedure Development: Principles, Prior Knowledge, and Change Management 202AB #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 #518: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics 117 #519: Patient Registries: Basket Trial or Basket Case? 116

11:30am EDT

#520 POS: Professional Poster Session II Exchange

11:40am EDT

#521 CH: Achieving Representative Enrollment in Phase 3 Lupus Clinical Trials: A Case Study Content Hub

11:45am EDT

#522 IT: Artos, Inc Innovation Theater: AI Isn't About Generating Documents, it's About Generating Data Innovation Theater 2 #521.1 SS: Spark Stage: Patient Appreciation Session: Celebrating the Patient Voice Spark Stage #523 IT: Syneos Health Innovation Theater: More Doesn't Guarantee Better - Why AI Success Depends on Organizational Agility, Not Just the Tech Innovation Theater 1

12:25pm EDT

#524 IT: Vivpro Corporation Innovation Theater: AI in Action - Scaling Regulatory Document Generation Across R&D Innovation Theater 2 #525 IT: Yseop Innovation Theater: Design Regulatory Grade AI - Enable Scalable, Consistent Workflows Across Document Types Innovation Theater 1

12:30pm EDT

#526 RT: Roundtable Discussion: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis Zone A

1:05pm EDT

#527 IT: Certara Innovation Theater: LLM-Driven Submissions: From Data Preparation to eCTD Innovation Theater 1

1:45pm EDT

#528: Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention 118AB #529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase 108A #531: Tolerability in Immuno-Oncology: Patient Experience as a Core Element of Clinical Trials 107AB #530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials 108B #532: Applied Innovation for Patients: Implementing AI, Cloud, and Data in Regulatory Science 109AB #533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust 111AB #535: Unlock AI's Full Potential: The Power of FAIR Data 119AB #534: The Best Pitch Advice I Ever Got: How to Nail Main Stage Talks, Pitch Decks, and Any Talk of a Lifetime 103A #536: Project Management as a Catalyst for Enterprise Transformation 202AB #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 #542: Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions? 117 #543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making 116

3:15pm EDT

#546 IT: Collate Innovation Theater: A Thousand Document Types - An AI Platform Approach to Document Authoring and Intelligence Adopted by Global Enterprises Innovation Theater 1 #544 RT: Roundtable Discussion: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust Zone B #545 RT: Roundtable Discussion: Regulators Approach to Address Drug Shortages Zone A

4:15pm EDT

#547: Increasing Vigilance Transparency: When is the Right Time to Publish Safety Signals? 118AB #548: Clinical Research Training for Community Cancer Centers: A Pilot to Extend Clinical Trials into Diverse Catchment Areas 108A #549: Reimagining Site Source: Optimizing Clinical Trial Execution for Sponsors, Sites, and Patients 108B #550: Evolving Artificial Intelligence Regulatory Landscape in Drug Development Across US and EU 109AB #551: Operationalizing Large Language Models in Drug Development 111AB #552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate 105AB #563: Oncology Pathways Under Pressure: From CAR-T Access Today to Longevity-Driven Care Tomorrow 107AB #553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success 203AB #554: Reverse Pitches: How Pharma Actually Buys 103A #555: Adapting Regulatory Frameworks to Address Mass Distribution of Unapproved or Unauthorized Medicines 118C #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 #561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance 117 #562: Leveraging Real-World Evidence and External Controls in Clinical Trials of Rare Outcomes/Diseases: Statistical Innovation and Novel Applications 116

8:00am EDT

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

9:15am EDT

#601 IT: Faro Health Innovation Theater: Digital Protocols in Action - Enabling End-to-End Automation in Clinical Development Innovation Theater 1 #602 IT: PhaseV Trials Innovation Theater: From Protocol to Submission - The Real-World Impact of AI in Clinical Operations Innovation Theater 2

10:15am EDT

#603: From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures 118AB #604.1: Trial Navigator: Sponsors and Payors Discuss a Collaborative Non-Profit Recruitment Model to Better Connect Patients to Trials 116 #604: Counting the Cost: Translating Participant Burden into Fair Compensation 108B #603.1: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials 108A #605: Bridging the AI Divide: Regulatory Trends, Industry Innovation, and the Future of AI in Pharma & Biotech 109AB #607: Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies 115AB #606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis 107AB #601: Inside the Investor’s Mind: How Today’s Biotech Investors Choose Where to Place Their Bets 103A #609: Decision Under Uncertainty 203AB #610: From Dysfunctions to Dynamics: Mapping Hidden Assumptions to Strengthen Trust, Debate, and Accountability 105AB #608: Can You Complete Your Submission in 10 Weeks? 202AB #611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines 111AB #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 #616: How to Accelerate Utilization of Decentralized Clinical Trial: What are Issues to Perform Decentralized Clinical Trial? 117

11:30am EDT

#617 POS: Professional Poster Session III Exchange

11:40am EDT

#618 CH: Regulatory Excellence as an Enabler for Sustainable Manufacturing in Africa Content Hub

12:20pm EDT

#619 CH: The End of the Static Protocol: How Digital Blueprints Will Orchestrate the Next Generation of Clinical Trials Content Hub

12:30pm EDT

#620 RT: Roundtable Discussion: Can You Complete Your Submission in 10 weeks? Zone B #621 RT: Roundtable Discussion: International Regulatory Cooperation with the African Medicines Agency Zone A

1:45pm EDT

#622: Pharmacovigilance to Strengthen Vaccine Confidence and Address Hesitancy: Lessons from Brazil and Beyond 118AB #624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden 108B #623: Designing the Future: Emulation of Clinical Trials Using Real-World Data 108A #625: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences 109AB #626: Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print? 107AB #627: Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use 111AB #628: Beyond the Keyboard: Elevating Regulatory Writing with a Business Mindset 105AB #630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization 112AB #629: Inside the Biotech Breakthroughs: How Investors and Founders Build Winning Companies 103A #631: Bold Leadership: Embolden Your Team for Smart Risk-Taking 202AB #632: Program Manager: Jack of All Trades, Master of None? 203AB #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 #637: Destigmatizing 483 Observations 117 #638: Real World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples 116

3:00pm EDT

#629.2 RT: Roundtable Discussion: Insights Regarding Implementation of the ASAP Process TBD Roundtable Discussion: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences TBD

4:00pm EDT

#643: Utilizing Signal Detection Methodologies: A Toolkit for Diverse Product Types 118AB #645: Clinical Trial Experience Surveys: Sponsor Wide Implementation Across Countries and Therapy Areas 108B #644: 50,000 Participants, Two Countries, One DCT: Oversight That Worked 108A #646: Accelerating AI-Enabled Drug Discovery and Development with Federated Computing 109AB #647: Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development? 111AB #648: Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare 105AB #649: Who Owns Long-Term Follow-Up? Addressing Stakeholder Gaps in Gene Therapy Evidence Generation 119AB #650: Leading for Growth: Unlocking Individual Potential in Your Team 202AB #651: Regulatory CMC and Product Quality Hot Topics Discussion 118C #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 #658: Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases 117 #659: Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact 203AB #657: Great Science Isn’t Enough: Building Value Early in Emerging Biotech 103A

8:00am EDT

#700: Insights Regarding Implementation of the ASAP Process 118AB #701: No Report Left Behind: Human-Centered Safety Reporting 103A #702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision 109AB #703: How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization 111AB #704: The View from the Top: What is the Future of Medical Writing? 105AB #705: Fighting Medical Disinformation (Without Actually Starting a Fight) 108A #706: AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis 118C #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 #709: PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You 117 #710: Regulatory and Industry Perspectives on Good Clinical Practice Inspections: Regulatory Approaches, Industry Impact, and Future Harmonization Opportunities 107AB #711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives 116

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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