DIA 2026 Global Annual Meeting

DIA 2026 Global Annual Meeting

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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 Google Cloud Innovation Theater: Accelerating Discovery: The Shift to Agentic Research Workflows with Google’s Co-Scientist Innovation Theater 3

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

DIA 2026 Global Annual Meeting

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