DIA 2025 Global Annual Meeting

DIA 2025 Global Annual Meeting

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6:00am EDT

Rise, Shine & Flow: 30 Minute Morning Yoga at DIA 2025 Ballroom Foyer 3rd Floor

8:00am EDT

Registration West Salon

8:30am EDT

#301: Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report 204ABC #302: From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care 202A #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 #305: Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Automation and Regulatory Review 207B #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

9:30am EDT

Coffee Break EH

9:45am EDT

#313 IT: IQVIA Innovation Theater: Harnessing the Power of Artificial Intelligence in Medical Affairs - Driving Efficiencies and Preserving Trustworthiness Innovation Theater 1 #313.1 IT: Synterex, Inc Innovation Theater: AgileWriter.ai™ - Your All-in-One Solution for Authoring and Managing Clinical Trial Documentation Innovation Theater 2

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 #316: Research in Participants with Progressive Cognitive Impairment: Best Practices for Ensuring Continuing Informed Consent 150AB #317: Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa 209ABC #318: Patient Referral: Is It Hope or Hype? 201 #319: Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development 207B #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 #324: Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality 152AB #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 #329: Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance 206

11:30am EDT

#POS 3: Professional Poster Session III EH Luncheon Service Exhibit Hall Lunch

11:40am EDT

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

12:00pm EDT

#332 RT: Roundtable Discussion: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint Exhibit Hall / Zone B #333 RT: Roundtable Discussion: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships Exhibit Hall / Zone C #331 RT: Roundtable Discussion: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects Exhibit Hall / Zone A

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

#336: Addressing Challenges in Devices Safety Monitoring 202A #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 #348: Indonesia Town Hall 150AB #342: Evolving Regulatory Considerations for Medical Affairs Communications 151A #346: Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success 147AB #349: Potency Measurements for Cellular and Gene Therapy Products 143ABC #339: Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation 209ABC #350: Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Drug Development 144ABC #351: Transforming Industry through Mentorship 206

2:45pm EDT

Refreshment Break EH

2:55pm EDT

#353 RT: Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma Exhibit Hall / Zone B #352 RT: Roundtable Discussion: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products Exhibit Hall / Zone A #354 RT: Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability Exhibit Hall / Zone C

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 #361: Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability 202A #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 #369: Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20 144ABC #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

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Jun 9 - 19, 2025

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Washington, D.C., USA

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206
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209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
Exhibit Hall / Zone C
Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Room 151A
Salon B
TBD
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West Salon
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07: ProjectManagement-StrategicPlanning

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08: RD-Quality-Compliance

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09: Regulatory

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10: RegCMC-Product Quality

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11: Statistics-Data Science

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12: ProfDevelopment

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