DIA 2025 Global Annual Meeting

12P: Real-World Evidence: Navigating the Evolving Landscape of Regulation, Data, and Integration 1:00pm - 4:00pm

21A: Risk-Based Quality Management in Action: Hands-On with a Real Study Protocol 9:30am - 12:30pm

22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development 1:00pm - 4:00pm

31A: Cell and Gene Therapies 101: Specific Regulatory, CMC, Non-Clinical, and Clinical Requirements and Considerations 9:30am - 12:30pm

32P: Introduction to Artificial intelligence (AI) Ethics, Regulations and Governance for Life Sciences 1:00pm - 4:00pm

41A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials 9:30am - 12:30pm

42P: Regulatory Strategy Development for Complex Devices and Combination Products 1:00pm - 4:00pm

Registration 12:30pm - 6:00pm

#134: Building a Regulatory Landscape to Support CMC Innovation 2:15pm - 3:15pm

#150: Prior Knowledge - How Experience of the Past Can Drive the... 3:45pm - 4:45pm

#135: Harnessing the Power of Generative AI: From Prompt Enginee... 2:15pm - 3:15pm

#142: Enhancing Evidence Generation Across Pharmaceutical Life C... 3:45pm - 4:45pm

#133: Health Canada Town Hall 2:15pm - 3:15pm

#148: Applying Principles of Global Regulatory Collaboration to... 3:45pm - 4:45pm

#114: Leveraging Global Identification of Medicinal Products Sta... 11:00am - 12:00pm

#147: Generative Artificial Intelligence in Regulatory Affairs:... 3:45pm - 4:45pm

#111: Project Orbis: Six Years Later 11:00am - 12:00pm

#132: FDA Legislation 2025: How is Congress Preparing to Advance... 2:15pm - 3:15pm

#146: FDA Accelerated Approval Program: Putting Withdrawals in C... 3:45pm - 4:45pm

#131: International Regulatory Harmonization for Development of... 2:15pm - 3:15pm

#149: WHO Town Hall: Driving Innovation and Access - Global Coll... 3:45pm - 4:45pm

#126: Best Practices for Navigating Divergent Regulatory Feedbac... 2:15pm - 3:15pm

#140: Unlocking the Future of Clinical Trials: How the ICH M11 D... 3:45pm - 4:45pm

#110: Moving Toward Pragmatism in Clinical Trials 11:00am - 12:00pm

#129: Models of Collaborations to Advance Regulatory Science: Le... 2:15pm - 3:15pm

#144: Spinning Plates and Juggling Chainsaws: Mastering the Art... 3:45pm - 4:45pm

#109: Why do Good Clinical Practice Inspectors Do Things Differe... 11:00am - 12:00pm

#130: Innovation at the Intersection: Clinical Operations, Data... 2:15pm - 3:15pm

#145: Integrating Clinical Trials and Clinical Care: The Who, Wh... 3:45pm - 4:45pm

#112: Unintended Consequences: Effects of Inflation Reduction Ac... 11:00am - 12:00pm

#136: Tech-Enabled Clinical Development: Public Sector Innovatio... 2:15pm - 3:15pm

#152: AI in Patient Care: Aspirations and Considerations 3:45pm - 4:45pm

#107: From Approval to Access: Integrating Patient Insights into... 11:00am - 12:00pm

#127: Clinical Care vs Research: Walking the Ethical Tightrope B... 2:15pm - 3:15pm

#141: How Soon is Too Soon? Enhancing Early Regulatory Engagemen... 3:45pm - 4:45pm

#108: Advancing Innovation Through Essential Drug Delivery Outpu... 11:00am - 12:00pm

#128: Leveraging the Capabilities of Artificial Intelligence and... 2:15pm - 3:15pm

#143: Ethics in the Era of Precision Medicine and Advancing Tech... 3:45pm - 4:45pm

#151: Mastering the Power of Words: Elevate Performance and Comp... 3:45pm - 4:45pm

#104: A Regulator's View on the Future Vision for Pharmacovigila... 11:00am - 12:00pm

#123: A Masterclass: Patient Recruitment Campaign Management 2:15pm - 3:15pm

#137: Pharmacovigilance: Beyond Signal Detection and Spontaneous... 3:45pm - 4:45pm

#106: Real-World Evidence: First Choice or Last Resort? 11:00am - 12:00pm

#125: Setting the Bar High: Facilitating Quality and Acceptabili... 2:15pm - 3:15pm

#139: Efficient Data Exchange: Drivers for End-to-End Standards... 3:45pm - 4:45pm

#105: Advancing Clinical Outcomes through Digital Health Technol... 11:00am - 12:00pm

#124: Expanding Innovative Master Protocol Trial Designs to Cell... 2:15pm - 3:15pm

#138: Advances in Clinical Trial Linkage to Real-World Data: Bri... 3:45pm - 4:45pm

#100: Opening Plenary and Keynote Address: From Personal Journeys to Global Solutions – Collaborating for Innovation and Patient... 8:00am - 10:00am

Coffee and Light Refreshments 7:00am - 8:00am

Coffee Break 10:00am - 11:00am

#POS 1: Student Poster Session I 12:00pm - 2:00pm

Luncheon Service 12:00pm - 2:00pm

#101 IT: IQVIA Innovation Theate... 10:15am - 10:45am

#117 IT: AlphaLife Science Innovation Theater: AI in Action - En... 12:55pm - 1:55pm

#121 IT: Taimei Technology Innov... 1:35pm - 2:05pm

#103 IT: OM1 Innovation Theater:... 10:15am - 10:45am

#115.1 IT: Salesforce Innovation... 12:15pm - 12:45pm

#122 IT: Parexel Innovation Thea... 1:35pm - 2:05pm

#102 IT: Lokavant, Inc Innovatio... 10:15am - 10:45am

#118 IT: PCM Trials Innovation T... 12:55pm - 1:25pm

#120 IT: Evernorth Health Servic... 1:35pm - 2:05pm

#115 CH: Leading Teams Through O... 12:10pm - 12:40pm

#119 CH: Development of Regulatory Strategies for Global Evaluat... 1:30pm - 2:30pm

#113: Accelerating Global Access to Drugs for Chronic Diseases 11:00am - 12:00pm

#136.1: Ushering in a New Era of Africa Healthcare 2:15pm - 3:15pm

#204: Real-World Data Traceability: Challenges and Solutions Whe... 8:30am - 9:30am

#228: Advancing a Global Regulatory Approach to Pharmaceutical Q... 10:30am - 11:30am

#252: Harnessing Opportunities Through Inspection Reliance: A Pa... 1:45pm - 2:45pm

#274: Global Collaborative Review: Understanding Overall Control... 4:00pm - 5:00pm

#208: International Harmonization in Real-World Evidence: Recent... 8:30am - 9:30am

#229: Bayesian Benefit-Risk Analysis: A Framework for Quantitati... 10:30am - 11:30am

#253: Statistical Challenges and Innovations in Small-Sized Clin... 1:45pm - 2:45pm

#275: Externally Controlled Trials in Clinical Development: Chal... 4:00pm - 5:00pm

#209: A Platform for Platforms? The Intersection of the Platform... 8:30am - 9:30am

#227: ANVISA Town Hall 10:30am - 11:30am

#251: China Town Hall 1:45pm - 2:45pm

#272: Towards Instantaneous Regulatory Decisions and Better Pred... 4:00pm - 5:00pm

#211: Redesigning Research and Development with Women in Mind: T... 8:30am - 9:30am

#226: US and EU Orphan Drug Regulations: Shaping the Ecosystem f... 10:30am - 11:30am

#246: US Executive Orders: Impact on Precision Medicine and Diag... 1:45pm - 2:45pm

#270: Patient Engagement in Trial Design and the Evolving Landsc... 4:00pm - 5:00pm

#207: Japan Town Hall 8:30am - 9:30am

#225: Pathways to Innovation: Navigating Regulatory Expectations... 10:30am - 11:30am

#249: Harmonizing Data Quality Frameworks: Bridging Regulatory P... 1:45pm - 2:45pm

#271: Enhancing Global Access to Innovative Therapies: Regulator... 4:00pm - 5:00pm

#215: The Need for a Multi-Stakeholder Collaboration to Moderniz... 10:30am - 11:30am

#242: Not all AI is Equal: Ensuring Reliable, Responsible AI to... 1:45pm - 2:45pm

#268: New Data and Insights on the Vendor Qualification Process... 4:00pm - 5:00pm

#205: Revolutionizing Medical Writing: Building the Assistive Te... 8:30am - 9:30am

#219: Resilient Leadership: Overcoming Isolation and Adversity 10:30am - 11:30am

#244: How Medical Writing and Regulatory Strategy Can Support Ac... 1:45pm - 2:45pm

#265: Breaking Barriers: Making Health Information Accessible to... 4:00pm - 5:00pm

#210: MHRA Town Hall 8:30am - 9:30am

#223: Transforming the Project Management Role to Meet the Emerg... 10:30am - 11:30am

#247: Guerrilla Strategic Delivery 1:45pm - 2:45pm

#267: Delivering Effective Business Transformations and How to A... 4:00pm - 5:00pm

#206: Alphabet Soup: Utilization of Quality-by-Design and Risk-B... 8:30am - 9:30am

#224: FDA, MHRA, Health Canada Views on Data Flow: The Backbone... 10:30am - 11:30am

#248: Embracing ICH E6(R3) with Risk-Based Quality Management 1:45pm - 2:45pm

#269: Pharmacovigilance Inspections Fireside Chat 4:00pm - 5:00pm

#221: Participant Compensation in Clinical Trials: Exploring Tod... 10:30am - 11:30am

#277: Getting the Work of Medicines Development and Manufacturin... 4:00pm - 5:00pm

#220: Novel Framework and Case Study to Support Scientific Rigor... 10:30am - 11:30am

#245: Addressing Participation Burden in Clinical Trials: Eviden... 1:45pm - 2:45pm

#262: Overcoming Site Burden: Driving Adoption of Automation and... 4:00pm - 5:00pm

#222: Innovative Regulatory Approaches for Developing Diagnostic... 10:30am - 11:30am

#241: Updating Ethics: What’s New (and why it Matters!) in the 2... 1:45pm - 2:45pm

#266: Opportunities for Innovation Under Fragmented Regulatory F... 4:00pm - 5:00pm

#202: From Measuring to Modeling the Patient Burden: An Interact... 8:30am - 9:30am

#230: Banishing Burnout: A Practice of Mindfulness Tools to Redu... 10:30am - 11:30am

#254: Charting New Courses: Reshaping Opportunities and Breaking... 1:45pm - 2:45pm

#276: Exploring Regulator Career Paths: How Breadth of Experienc... 4:00pm - 5:00pm

#201: Innovations in Signal Detection: Advancing Safety Signals... 8:30am - 9:30am

#216: The Globalization of Risk Management 10:30am - 11:30am

#240: Has Decentralized Trials Crashed, or Are We Just Getting S... 1:45pm - 2:45pm

#261: Advancing Premarketing Safety Analytics through FDA and In... 4:00pm - 5:00pm

#203: Realizing Value Through Responsible AI in Clinical Develop... 8:30am - 9:30am

#218: Innovation Reimagined: How Intelligent Automation is Redef... 10:30am - 11:30am

#243: The Adoption of Artificial Intelligence and Machine Learni... 1:45pm - 2:45pm

#264: How Do We Get from Here to There: Putting Real-World Data... 4:00pm - 5:00pm

#217: Case Studies of Application of AI in Risk-Based Quality Ma... 10:30am - 11:30am

#250: Pediatric Cluster Town Hall 1:45pm - 2:45pm

#263: Using Generative AI to Explore our Track Record on Paying... 4:00pm - 5:00pm

Coffee Break 9:30am - 10:30am

#POS 2: Professional Poster Session II 11:30am - 1:30pm

Luncheon Service 11:30am - 1:30pm

Refreshment Break 2:45pm - 3:45pm

#234 RT: Roundtable Discussion: Applying Principles of Global Re... 12:00pm - 1:00pm

#255 RT: Roundtable Discussion: International Regulatory Harmoni... 2:55pm - 3:55pm

#235 RT: Roundtable Discussion: Building a Regulatory Landscape... 12:00pm - 1:00pm

#256 RT: Roundtable Discussion: Alphabet Soup - Utilization of Q... 2:55pm - 3:55pm

#235.1 RT: Roundtable Discussion: Clinical Care vs Research - Wa... 12:00pm - 1:00pm

#256.1 RT: Roundtable Discussion: Participant Compensation in Cl... 2:55pm - 3:55pm

DIA Global Annual Meeting Blood Drive 11:00am - 4:00pm

#212 IT: IQVIA Innovation Theate... 9:45am - 10:15am

#232: Arnold Ventures Innovation... 11:45am - 12:15pm

#236.1 IT: Whatfix Innovation Th... 12:25pm - 12:55pm

#239 IT: Syneos Health Innovatio... 1:05pm - 1:35pm

#260 IT: Weave Bio Innovation Th... 3:00pm - 3:30pm

#213 IT: Clario Innovation Theat... 9:45am - 10:15am

#233 IT: Yseop Innovation Theate... 11:45am - 12:15pm

#237.1 IT: Salesforce Innovation... 12:25pm - 12:55pm

#258 IT: Certera Innovation Thea... 3:00pm - 3:30pm

#214 IT: Aris Global Innovation... 9:45am - 10:15am

#233.1 IT: Microsoft Innovation... 11:45am - 12:15pm

#237 IT: Lilly Innovation Theate... 12:25pm - 12:55pm

#239.1 IT: Faro Health, Inc Inno... 1:05pm - 1:35pm

#259 IT: Milliman IntelliScript... 3:00pm - 3:30pm

#238 CH: Navigating AI Regulatio... 1:00pm - 1:30pm

#257 CH: Innovative Complex Clin... 3:00pm - 3:30pm

Coffee and Light Refreshments 8:00am - 8:30am

#273: Regulatory Cooperation Between US and Japan 4:00pm - 5:00pm

#231 CH: Using Digital Protocols... 11:40am - 12:10pm

#311: How to Reduce Post-Approval Changes Complexity Through Agi... 8:30am - 9:30am

#327: Quality Oversight: Enhancing Approaches Across Organizatio... 10:30am - 11:30am

#349: Potency Measurements for Cellular and Gene Therapy Product... 1:45pm - 2:45pm

#368: Perspectives on the Adoption of Advanced Manufacturing Tec... 4:00pm - 5:00pm

#325: Practical Implementation of MRCTs Based on ICH E17 Guideli... 10:30am - 11:30am

#350: Unleash the Potential of Synthetic Data and Digital Twins... 1:45pm - 2:45pm

#369: Considerations for Adaptive Design Using Bayesian Methods:... 4:00pm - 5:00pm

#310: Global Integration of the Middle East Region: Growing, Dev... 8:30am - 9:30am

#314: From Guidelines to Real-World Impact: Considerations for t... 10:30am - 11:30am

#345: Africa's Evolving Regulatory Landscape 1:45pm - 2:45pm

#370: Modernizing Evidence in Oncology: Real World Data and Arti... 4:00pm - 5:00pm

#312: Rare but Real: Navigating Rare Disease Product Development... 8:30am - 9:30am

#328: Artificial Intelligence in the Medicines Lifecycle: Delive... 10:30am - 11:30am

#347: EMA Town Hall 1:45pm - 2:45pm

#366: FDA Rare Disease Town Hall 4:00pm - 5:00pm

#308: The Role of Medical Device/IVD Regulatory Consulting in Na... 8:30am - 9:30am

#326: Clinical Trial Innovation at Scale: Opportunities to Incre... 10:30am - 11:30am

#346: Innovative Operating Models in Regulatory Affairs Driving... 1:45pm - 2:45pm

#367: Beyond Weight Loss: Pioneering the Future of Obesity Drug... 4:00pm - 5:00pm

#309: Building Upon Quality by Design and Risk-Based Monitoring... 8:30am - 9:30am

#316: Research in Participants with Progressive Cognitive Impair... 10:30am - 11:30am

#348: Indonesia Town Hall 1:45pm - 2:45pm

#365: International Regulatory Engagement for Advancing Regulato... 4:00pm - 5:00pm

#320: Delivering Business Value by Utilizing AI and Structured C... 10:30am - 11:30am

#342: Evolving Regulatory Considerations for Medical Affairs Com... 1:45pm - 2:45pm

#364: Beyond Clinical-Outcome Assessments: Best Practices for Su... 4:00pm - 5:00pm

#323: Why Does Drug Loss Occur? Challenges to be Addressed for P... 10:30am - 11:30am

#343: Portfolio Management in Pharma: Strategies and Insights fr... 1:45pm - 2:45pm

#357: Examining Bias in Lung Cancer Study Protocols: Lessons Lea... 4:00pm - 5:00pm

#306: Tackling Fraud and Misconduct in Clinical Trials: Regulato... 8:30am - 9:30am

#324: Do Flexible Trial Approaches Impede Data Quality? Percepti... 10:30am - 11:30am

#344: Pharmacovigilance Inspections: How Do Inspectors Decide Wh... 1:45pm - 2:45pm

#363: Critical to Quality Assessment Reports from Inception to O... 4:00pm - 5:00pm

#318: Patient Referral: Is It Hope or Hype? 10:30am - 11:30am

#340: Post-Marketing Safety Management in Asia Using Real-World... 1:45pm - 2:45pm

#362: Collaborating for Equity: Reaching Communities Through Par... 4:00pm - 5:00pm

#302: From Bedside to Bench to Bedside: How Adverse Events Conve... 8:30am - 9:30am

#321: Why Patient/Site Collaboration is a Must Have to Ensure Ac... 10:30am - 11:30am

#336: Addressing Challenges in Devices Safety Monitoring 1:45pm - 2:45pm

#361: Enhancing the Integration of Patient Experience in Assessi... 4:00pm - 5:00pm

#301: Newly Released Benefit-Risk Balance for Medicinal Products... 8:30am - 9:30am

#322: Navigating the Challenges of Drug Delivery Using a Novel D... 10:30am - 11:30am

#338: Clinical Development of Orphan and Pediatric Drugs, Along... 1:45pm - 2:45pm

#360: Maximizing the Voice of the Patient in Healthcare Decision... 4:00pm - 5:00pm

#329: Leader Effectiveness: Inclusive Leadership Practices to Im... 10:30am - 11:30am

#351: Transforming Industry through Mentorship 1:45pm - 2:45pm

#371: Business Agility: Recognizing Global Business Environment... 4:00pm - 5:00pm

#303: Electronic Submission of Safety Reports using E2B R3 stand... 8:30am - 9:30am

#315: Data and Methods for Signal Detection: Where are we Today... 10:30am - 11:30am

#337: AI, Virtual Control Groups, and Organoids: How New Technol... 1:45pm - 2:45pm

#356: Enhancing Pharmacovigilance and Reducing Medication Errors... 4:00pm - 5:00pm

#305: Transforming the Protocol from a Document-Centric to a Dat... 8:30am - 9:30am

#319: Regulatory and HTA Considerations When Using External Evid... 10:30am - 11:30am

#341: Techquity in Digital Trials: Tech, Data, and Operationaliz... 1:45pm - 2:45pm

#358: Privacy-Preserving Data Access and Collaboration for RWE G... 4:00pm - 5:00pm

#304: Expanding Research Participation through Local Health Care... 8:30am - 9:30am

#317: Partnerships and Collaboration: How to Drive Clinical Tria... 10:30am - 11:30am

#339: Pharmaceutical Quality Knowledge Management Platform Suppo... 1:45pm - 2:45pm

#359: Cutting Through the Hype: How are AI and Emerging Technolo... 4:00pm - 5:00pm

Coffee Break 9:30am - 10:30am

#POS 3: Professional Poster Session III 11:30am - 1:30pm

Refreshment Break 2:45pm - 3:45pm

#331 RT: Roundtable Discussion: Transforming the Project Managem... 12:00pm - 1:00pm

#352 RT: Roundtable Discussion: Enhancing Global Access to Innov... 2:55pm - 3:55pm

#332 RT: Roundtable Discussion: Statistical Challenges and Innov... 12:00pm - 1:00pm

#353 RT: Roundtable Discussion: Portfolio Management in Pharma -... 2:55pm - 3:55pm

#333 RT: Roundtable Discussion: Advancing Premarketing Safety An... 12:00pm - 1:00pm

#354 RT: Roundtable Discussion: Towards Instantaneous Regulatory... 2:55pm - 3:55pm

Luncheon Service 11:30am - 1:30pm

#313 IT: IQVIA Innovation Theate... 9:45am - 10:15am

#313.1 IT: Synterex, Inc Innovat... 9:45am - 10:15am

#330 CH: Pharmacoequity: The Rou... 11:40am - 12:10pm

#334 CH: Addressing Key Challeng... 12:20pm - 12:50pm

#335 CH: Can Drug Repurposing Be... 1:00pm - 1:30pm

#355 CH: Business Agility in the... 3:00pm - 3:30pm

#307: Regulators and Communication in a Changing World: The ICMR... 8:30am - 9:30am

#406: Beyond the Frequentist Approach in Hard to Recruit Populat... 9:00am - 10:00am

#402: Quality Risk Management for a Decentralized/Hybrid Clinica... 9:00am - 10:00am

#408: FDA Town Hall 10:30am - 12:00pm

#405: EMA - FDA Question Time 9:00am - 10:00am

#401: Implementing the Aggregate Safety Assessment Planning and... 9:00am - 10:00am

#407: Bridging Science and Business: A Roadmap from Pharmaceutic... 9:00am - 10:00am

#404: Embedding and Leveraging AI for Quality and Compliance in... 9:00am - 10:00am

#403: How AI is Transforming the Area of Data Standards and Acce... 9:00am - 10:00am

Coffee and Light Refreshments 8:00am - 9:00am

Coffee Break 10:00am - 10:30am