DIA 2025 Global Annual Meeting

DIA 2025 Global Annual Meeting

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6:30am EDT

CISCRP's Annual 2025 Medical Heroes Appreciation 5K Run & Walk

8:00am EDT

Coffee and Light Refreshments Room 145-147 Lobby Registration West Salon

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 #206: Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective 152AB #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 #211: Redesigning Research and Development with Women in Mind: Turning Ambition to Impact 146BC

9:30am EDT

Coffee Break EH

9:45am EDT

#212 IT: IQVIA Innovation Theater: The Future is Now - Transforming Regulatory Processes through AI, ML, NLP, and RPAs Innovation Theater 1 #213 IT: Clario Innovation Theater: Striking the Balance - Integrating Patient-Friendly Solutions Without Compromising Quality Science Innovation Theater 2 #214 IT: Aris Global Innovation Theater: Successful Implementation of Gen AI in Pharma - Strategy, ROI, and Cultural Transformation Innovation Theater 3

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 #222: Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers 204ABC #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 #218: Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence 207B #228: Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management 143ABC #229: Bayesian Benefit-Risk Analysis: A Framework for Quantitative Evidence-Based Decision Making in Medical Product Development 144ABC #230: Banishing Burnout: A Practice of Mindfulness Tools to Reduce Stress and Improve Well-Being 206

11:00am EDT

DIA Global Annual Meeting Blood Drive Exhibit Hall Lunch

11:30am EDT

#POS 2: Professional Poster Session II EH Luncheon Service EH

11:40am EDT

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

11:45am EDT

#232: Arnold Ventures Innovation Theater: Biosimilars Today - Who is Winning the Global Race? Innovation Theater 1 #233 IT: Yseop Innovation Theater: Scaling Regulatory Automation - The One-Click Vision Innovation Theater 2 #233.1 IT: Microsoft Innovation Theater: Innovating Responsibly - AI in Regulated Environments Innovation Theater 3

12:00pm EDT

#234 RT: Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease Exhibit Hall / Zone A #235.1 RT: Roundtable Discussion: Clinical Care vs Research - Walking the Ethical Tightrope Between Advocacy and Coercion and Updating Ethics What's New in Declaration of Helsinki Exhibit Hall / Zone C #235 RT: Roundtable Discussion: Building a Regulatory Landscape to Support CMC Innovation Exhibit Hall / Zone B

12:25pm EDT

#236.1 IT: Whatfix Innovation Theater: Closing the Digital Execution Gap in Life Science - A Practical Path to Compliance, Efficiency, and Speed Innovation Theater 1 #237 IT: Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies Innovation Theater 3 #237.1 IT: Salesforce Innovation Theater: Life Sciences Cloud - An Intelligent Clinical Engagement Platform Innovation Theater 2

1:00pm EDT

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

1:05pm EDT

#239 IT: Syneos Health Innovation Theater: From Pilot to Powerhouse - Scaling AI for Life Sciences Innovation Theater 1 #239.1 IT: Faro Health, Inc Innovation Theater: Real World Applications of AI to Clinical Development Innovation Theater 3

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 #243: The Adoption of Artificial Intelligence and Machine Learning in Clinical Research 207B #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

2:45pm EDT

Refreshment Break EH

2:55pm EDT

#256 RT: Roundtable Discussion: Alphabet Soup - Utilization of Quality by Design and Risk Based Quality Management in Clinical Trials Data Goverernance Exhibit Hall / Zone B #256.1 RT: Roundtable Discussion: Participant Compensation in Clinical Trials and Using Generative AI to Explore our Track Record on Paying Participants Exhibit Hall / Zone C #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

3:00pm EDT

#257 CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development L Street Bridge #258 IT: Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier Innovation Theater 2 #259 IT: Milliman IntelliScript Innovation Theater: What are you Missing in Recruitment and Enrollment? Innovation Theater 3 #260 IT: Weave Bio Innovation Theater: Advancing the Regulatory Lifecycle - Evolution of the Weave Platform Innovation Theater 1

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 #263: Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation 209ABC #264: How Do We Get from Here to There: Putting Real-World Data Quality Assessments into Practice 207B #265: Breaking Barriers: Making Health Information Accessible to All 151A #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 #276: Exploring Regulator Career Paths: How Breadth of Experience Informs Decision Making and Medicines Development? 206 #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

6:45pm EDT

DIA at the Nationals Park Nationals Park

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Ballroom Foyer 3rd Floor
EH
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Exhibit Hall Lunch
Innovation Theater 1
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Nationals Park
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Room 151A
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