DIA 2025 Global Annual Meeting

DIA 2025 Global Annual Meeting

11:00am EDT

#106: Real-World Evidence: First Choice or Last Resort? 207B #107: From Approval to Access: Integrating Patient Insights into Coverage Decisions 202A #109: Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized 152AB #111: Project Orbis: Six Years Later 147AB #112: Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation 201 #113: Accelerating Global Access to Drugs for Chronic Diseases Salon B #108: Advancing Innovation Through Essential Drug Delivery Outputs 204ABC #114: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives 146BC

2:15pm EDT

#124: Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases 209ABC #123: A Masterclass: Patient Recruitment Campaign Management 207A #130: Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management 152AB #131: International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here 150AB #132: FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding? 147AB #133: Health Canada Town Hall 145AB #125: Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence 207B #126: Best Practices for Navigating Divergent Regulatory Feedback 151A

3:45pm EDT

#138: Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials 209ABC #139: Efficient Data Exchange: Drivers for End-to-End Standards Adoption 207B #141: How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development 202A #142: Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience 144ABC #143: Ethics in the Era of Precision Medicine and Advancing Technologies 204ABC #145: Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How 152AB #146: FDA Accelerated Approval Program: Putting Withdrawals in Context 147AB #148: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease 145AB #149: WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation 150AB #140: Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders 151A #144: Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management 151B #151: Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication 206

8:30am EDT

#201: Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates 207A #202: From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age 206 #203: Realizing Value Through Responsible AI in Clinical Development 207B #205: Revolutionizing Medical Writing: Building the Assistive Technology Ecosystem 151A #207: Japan Town Hall 147AB #208: International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers 144ABC #209: A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge 145AB #210: MHRA Town Hall 151B #204: Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence 143ABC

10:30am EDT

#215: The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What? 150AB #216: The Globalization of Risk Management 207A #217: Case Studies of Application of AI in Risk-Based Quality Management 209ABC #219: Resilient Leadership: Overcoming Isolation and Adversity 151A #220: Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation 202A #221: Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities 201 #223: Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects 151B #224: FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct 152AB #225: Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development 147AB #226: US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases 146BC #227: ANVISA Town Hall 145AB

11:40am EDT

#231 CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials TBD

1:00pm EDT

#238 CH: Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts L Street Bridge

1:45pm EDT

#240: Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology 207A #241: Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision 204ABC #242: Not all AI is Equal: Ensuring Reliable, Responsible AI to Accelerate Adoption, Innovation, and Impact 150AB #244: How Medical Writing and Regulatory Strategy Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot 151A #245: Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact 202A #246: US Executive Orders: Impact on Precision Medicine and Diagnostic Development 146BC #247: Guerrilla Strategic Delivery 151B #248: Embracing ICH E6(R3) with Risk-Based Quality Management 152AB #249: Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives 147AB #250: Pediatric Cluster Town Hall 209ABC #251: China Town Hall 145AB #252: Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency 143ABC #253: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint 144ABC #254: Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development 206

2:55pm EDT

#255 RT: Roundtable Discussion: International Regulatory Harmonization for Development of Medicines - A Look at How far We’ve Come and Where We Go From Here Exhibit Hall / Zone A

4:00pm EDT

#261: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships 207A #262: Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration 202A #270: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance 146BC #266: Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics 204ABC #267: Delivering Effective Business Transformations and How to Apply them to Drug Development 151B #268: New Data and Insights on the Vendor Qualification Process in Drug Development 150AB #269: Pharmacovigilance Inspections Fireside Chat 152AB #271: Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products 147AB #272: Towards Instantaneous Regulatory Decisions and Better Predictability 145AB #273: Regulatory Cooperation Between US and Japan Salon B #274: Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk 143ABC #275: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies 144ABC #277: Getting the Work of Medicines Development and Manufacturing Done by Hook or by Crook: Attracting, Retaining and Developing Key Talent in the New World of Work 201

8:30am EDT

#301: Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report 204ABC #303: Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime? 207A #304: Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities 209ABC #306: Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives 152AB #307: Regulators and Communication in a Changing World: The ICMRA Role Room 151A #308: The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways 147AB #309: Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum 150AB #310: Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards 145AB #311: How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance 143ABC #312: Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges 146BC

10:30am EDT

#314: From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14 145AB #315: Data and Methods for Signal Detection: Where are we Today and What is the Current State of the Art 207A #317: Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa 209ABC #318: Patient Referral: Is It Hope or Hype? 201 #320: Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing 151A #321: Why Patient/Site Collaboration is a Must Have to Ensure Accessibility of Digital Health Technologies and Development of Patient Relevant Clinical Endpoints 202A #323: Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development 151B #325: Practical Implementation of MRCTs Based on ICH E17 Guidelines 144ABC #326: Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance 147AB #322: Navigating the Challenges of Drug Delivery Using a Novel Device 204ABC #327: Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval 143ABC #328: Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health 146BC

11:40am EDT

#330 CH: Pharmacoequity: The Route to Representative Clinical Trials in the Current Political Environment L Street Bridge

12:20pm EDT

#334 CH: Addressing Key Challenges in Global Biosimilar Development and Regulation L Street Bridge

1:00pm EDT

#335 CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases? L Street Bridge

1:45pm EDT

#337: AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research 207A #338: Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan 204ABC #340: Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe 201 #341: Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research 207B #343: Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations 151B #344: Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go? 152AB #345: Africa's Evolving Regulatory Landscape 145AB #347: EMA Town Hall 146BC #342: Evolving Regulatory Considerations for Medical Affairs Communications 151A #339: Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation 209ABC

3:00pm EDT

#355 CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out L Street Bridge

4:00pm EDT

#356: Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels 207A #357: Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders 151B #358: Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges 207B #359: Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now? 209ABC #360: Maximizing the Voice of the Patient in Healthcare Decision-Making: Integrating Patient Experience Data into Regulatory, Value Assessment, and Payer Decision-Making 204ABC #362: Collaborating for Equity: Reaching Communities Through Partnerships with Federally Qualified Health Centers and Community Health Workers 201 #363: Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders 152AB #365: International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs 150AB #366: FDA Rare Disease Town Hall 146BC #367: Beyond Weight Loss: Pioneering the Future of Obesity Drug Development 147AB #368: Perspectives on the Adoption of Advanced Manufacturing Technologies 143ABC #370: Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development 145AB #364: Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators 151A #371: Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations 206

9:00am EDT

#401: Implementing the Aggregate Safety Assessment Planning and Aggregate Safety Review with an Interactive Application: Learnings and Enhancements 151A #402: Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders 145AB #403: How AI is Transforming the Area of Data Standards and Access to Source Data 207B #404: Embedding and Leveraging AI for Quality and Compliance in Pharma 152AB #405: EMA - FDA Question Time 146BC #406: Beyond the Frequentist Approach in Hard to Recruit Populations: Acceptance of Bayesian Methods for Registration/Pivotal Trial 144ABC #407: Bridging Science and Business: A Roadmap from Pharmaceutical Research to Successful Entrepreneurship 151B

10:30am EDT

#408: FDA Town Hall 146ABC

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