DIA 2026 Global Annual Meeting

DIA 2026 Global Annual Meeting

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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

DIA 2026 Global Annual Meeting

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