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Walter E. Washington Convention Center

Jun 15, 2025 7:00 AM - Jun 19, 2025 3:00 PM

801 Allen Y. Lew Place, NW, Washington, DC 20001-3614, USA

DIA 2025 Global Annual Meeting

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Agenda

8:30 AM — 10:00 AM

Opening Plenary and Keynote Address: From Personal Journeys to Global Solutions – Collaborating for Innovation and Patient Impact

10:15 AM — 10:45 AM

IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI

10:15 AM — 10:45 AM

Lokavant, Inc Innovation Theater: Applying the Scientific Method to Clinical Trials: Building the Evidence for AI-Driven Transformation

11:00 AM — 12:00 PM

A Regulator's View on the Future Vision for Pharmacovigilance

11:00 AM — 12:00 PM

Advancing Clinical Outcomes through Digital Health Technology Innovation

11:00 AM — 12:00 PM

Advancing Innovation Through Essential Drug Delivery Outputs

11:00 AM — 12:00 PM

From Approval to Access: Integrating Patient Insights into Coverage Decisions

11:00 AM — 12:00 PM

Is Real-World Evidence Always a Last Resort?

11:00 AM — 12:00 PM

Moving Toward Pragmatism in Clinical Trials

11:00 AM — 12:00 PM

Project Orbis: Six Years Later

11:00 AM — 12:00 PM

Putting Patients First: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives

11:00 AM — 12:00 PM

Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation

11:00 AM — 12:00 PM

Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized

12:00 PM — 2:00 PM

DIAmond Session Solution Room: The Role of Identification of Medicinal Products in the Future of Global Healthcare

12:00 PM — 2:00 PM

Professional and Student Poster Session 1

12:55 PM — 1:55 PM

AlphaLife Science Innovation Theater: GenAI in Action - Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma

12:55 PM — 1:25 PM

PCM Trials Innovation Theater: Insights from Across the Care Continuum - How Community-Based Research Supports Trial Success

1:35 PM — 2:05 PM

Evernorth Health Services Innovation Theater: Empowering Case Managers - Bridging Patient Education and Oncology Clinical Trial Enrollment

1:35 PM — 2:05 PM

Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce

1:35 PM — 2:05 PM

Taimei Technology Innovation Theater: Transforming eClinical Platform - The New Era of Agentic AI in Data and TMF Management

2:15 PM — 3:15 PM

A Masterclass: Patient Recruitment Campaign Management

2:15 PM — 3:15 PM

Best Practices for Navigating Divergent Regulatory Feedback

2:15 PM — 3:15 PM

Building a Regulatory Landscape to Support CMC Innovation

2:15 PM — 3:15 PM

Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion

2:15 PM — 3:15 PM

Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases

2:15 PM — 3:15 PM

FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding?

2:15 PM — 3:15 PM

Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights

2:15 PM — 3:15 PM

Health Canada Town Hall

2:15 PM — 3:15 PM

Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management

2:15 PM — 3:15 PM

International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here

2:15 PM — 3:15 PM

Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine

2:15 PM — 3:15 PM

Models of Collaborations to Advance Regulatory Science: Lessons Learned

2:15 PM — 3:15 PM

Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence

2:15 PM — 3:15 PM

Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge

2:15 PM — 3:15 PM

Ushering in a New Era of Africa Healthcare

3:45 PM — 4:45 PM

Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials

3:45 PM — 4:45 PM

AI in Patient Care: Aspirations and Considerations

3:45 PM — 4:45 PM

Applying Principles of Global Regulatory Collaboration to Address Chronic Disease

3:45 PM — 4:45 PM

Efficient Data Exchange: Drivers for End-to-End Standards Adoption

3:45 PM — 4:45 PM

Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience

3:45 PM — 4:45 PM

Ethics in the Era of Precision Medicine and Advancing Technologies

3:45 PM — 4:45 PM

FDA Accelerated Approval Program: Putting Withdrawals in Context

3:45 PM — 4:45 PM

Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation

3:45 PM — 4:45 PM

How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development

3:45 PM — 4:45 PM

Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How

3:45 PM — 4:45 PM

Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication

3:45 PM — 4:45 PM

Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting

3:45 PM — 4:45 PM

Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C

3:45 PM — 4:45 PM

Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management

3:45 PM — 4:45 PM

Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders

3:45 PM — 4:45 PM

WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation

8:30 AM — 9:30 AM

A Platform for Platforms? The Intersection of the Platform Tech Designation and Prior Knowledge

8:30 AM — 9:30 AM

Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective

8:30 AM — 9:30 AM

Diversity Action Plans in Rare Genetic Disease Drug Development: Obstacles and Opportunities

8:30 AM — 9:30 AM

From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age

8:30 AM — 9:30 AM

Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates

8:30 AM — 9:30 AM

International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers

8:30 AM — 9:30 AM

Japan Town Hall

8:30 AM — 9:30 AM

Realizing Value Through Responsible AI in Clinical Development

8:30 AM — 9:30 AM

Real-World Data Traceability: Challenges and Solutions When Generating Real-World Evidence

8:30 AM — 9:30 AM

Redesigning Research and Development Policies with Women in Mind: Turning Ambition to Impact

8:30 AM — 9:30 AM

Revolutionizing Medical Writing: Evaluating and Building the Assistive Technology Ecosystem

9:45 AM — 10:15 AM

Aris Global Innovation Theater: Successful Implementation of Gen AI in Pharma - Strategy, ROI, and Cultural Transformation

9:45 AM — 10:15 AM

Clario Innovation Theater: Striking the Balance - Integrating Patient-Friendly Solutions Without Compromising Quality Science

9:45 AM — 10:15 AM

IQVIA Innovation Theater: The Future is Now - Transforming Regulatory Processes through AI, ML, NLP, and RPAs

10:30 AM — 11:30 AM

Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management

10:30 AM — 11:30 AM

ANVISA Town Hall

10:30 AM — 11:30 AM

Banishing Burnout: A Practice of Mindfulness Tools to Reduce Stress and Improve Well-Being

10:30 AM — 11:30 AM

Bayesian Benefit-Risk Analysis: A Framework for Quantitative Evidence-Based Decision Making in Medical Product Development

10:30 AM — 11:30 AM

Case Studies of Application of AI in Risk-Based Quality Management

10:30 AM — 11:30 AM

FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct

10:30 AM — 11:30 AM

Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence

10:30 AM — 11:30 AM

Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers

10:30 AM — 11:30 AM

Novel Framework and Case Study to Support Scientific Rigor: A New Community-Focused Model for Sustainable Clinical Trial Participation

10:30 AM — 11:30 AM

Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities

10:30 AM — 11:30 AM

Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development

10:30 AM — 11:30 AM

Resilient Leadership: Overcoming Isolation and Adversity

10:30 AM — 11:30 AM

The Globalization of Risk Management

10:30 AM — 11:30 AM

The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?

10:30 AM — 11:30 AM

Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects

10:30 AM — 11:30 AM

US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases

11:30 AM — 1:30 PM

DIAmond Session Solution Room: Redesigning Research and Development Policies with Women in Mind - Turning Ambition to Impact

11:30 AM — 1:30 PM

Professional Poster Session 2

11:45 AM — 12:15 PM

Arnold Ventures Innovation Theater: Biosimilars Today - Who is Winning the Global Race?

1:05 PM — 1:35 PM

Syneos Health Innovation Theater: From Pilot to Powerhouse - Scaling AI for Life Sciences

1:45 PM — 2:45 PM

Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact

1:45 PM — 2:45 PM

Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development

1:45 PM — 2:45 PM

China Town Hall

1:45 PM — 2:45 PM

Embracing ICH E6(R3) with Risk-Based Quality Management

1:45 PM — 2:45 PM

Guerrilla Strategic Delivery

1:45 PM — 2:45 PM

Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives

1:45 PM — 2:45 PM

Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency

1:45 PM — 2:45 PM

Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology

1:45 PM — 2:45 PM

How Medical Writing Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot

1:45 PM — 2:45 PM

Pediatric Cluster Town Hall

1:45 PM — 2:45 PM

Real-World Evidence to Optimize Risk Minimization Programs: How to Move from Art to Science

1:45 PM — 2:45 PM

Reliable AI in Biomedical Settings: A Framework for Trust and Innovation in an Evolving Landscape

1:45 PM — 2:45 PM

Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint

1:45 PM — 2:45 PM

The Adoption of Artificial Intelligence and Machine Learning in Clinical Research

1:45 PM — 2:45 PM

The Laboratory-Developed Tests Final Rule: New Developments and Compliance Insights

1:45 PM — 2:45 PM

Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision

3:00 PM — 3:30 PM

Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier

3:00 PM — 3:30 PM

Milliman IntelliScript Innovation Theater: What are you Missing in Recruitment and Enrollment?

3:00 PM — 3:30 PM

Weave Bio Innovation Theater: Advancing the Regulatory Lifecycle - Evolution of the Weave Platform

4:00 PM — 5:00 PM

Advancing Premarketing Safety Analytics through FDA and Industry Partnerships

4:00 PM — 5:00 PM

Breaking Barriers: Making Health Information Accessible to All

4:00 PM — 5:00 PM

Delivering Effective Business Transformations and How to Apply them to Drug Development

4:00 PM — 5:00 PM

Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products

4:00 PM — 5:00 PM

Exploring Regulator Career Paths: The Impact of Diversity on Decision Making and Medicines Development

4:00 PM — 5:00 PM

Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies

4:00 PM — 5:00 PM

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

4:00 PM — 5:00 PM

Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk

4:00 PM — 5:00 PM

How Do We Get from Here to There: Putting Real-World Data Quality Assessments into Practice

4:00 PM — 5:00 PM

Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics

4:00 PM — 5:00 PM

Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration

4:00 PM — 5:00 PM

Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance

4:00 PM — 5:00 PM

Pharmacovigilance Inspector Fireside Chat

4:00 PM — 5:00 PM

Towards Instantaneous Regulatory Decisions and Better Predictability

4:00 PM — 5:00 PM

Updated Tufts Center for the Study of Drug Development Benchmarks on Vendor Qualification Practices: Insights from the Evolving Pharma Landscape

4:00 PM — 5:00 PM

Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation

8:30 AM — 9:30 AM

Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum

8:30 AM — 9:30 AM

Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?

8:30 AM — 9:30 AM

Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities

8:30 AM — 9:30 AM

From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care

8:30 AM — 9:30 AM

Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards

8:30 AM — 9:30 AM

How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance

8:30 AM — 9:30 AM

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report

8:30 AM — 9:30 AM

Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges

8:30 AM — 9:30 AM

Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives

8:30 AM — 9:30 AM

The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways

8:30 AM — 9:30 AM

Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Automation and Regulatory Review

9:45 AM — 10:15 AM

IQVIA Innovation Theater: Harnessing the Power of Artificial Intelligence in Medical Affairs - Driving Efficiencies and Preserving Trustworthiness

10:30 AM — 11:30 AM

Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health

10:30 AM — 11:30 AM

Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance

10:30 AM — 11:30 AM

Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing

10:30 AM — 11:30 AM

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality

10:30 AM — 11:30 AM

From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14

10:30 AM — 11:30 AM

Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance

10:30 AM — 11:30 AM

Navigating the Challenges of Drug Delivery Using a Novel Device

10:30 AM — 11:30 AM

Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa

10:30 AM — 11:30 AM

Patient Referral: Is It Hope or Hype?

10:30 AM — 11:30 AM

Practical Implementation of MRCTs Based on ICH E17 Guidelines

10:30 AM — 11:30 AM

Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval

10:30 AM — 11:30 AM

Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development

10:30 AM — 11:30 AM

Research in Participants with Progressive Cognitive Impairment: Best Practices for Ensuring Continuing Informed Consent

10:30 AM — 11:30 AM

Trustworthy AI Solutions for Next-Generation Pharmacovigilance

10:30 AM — 11:30 AM

Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development

10:30 AM — 11:30 AM

Why Patient/Site Collaboration is a Must Have to Ensure Accessibility to Digital Health Technologies and Development of Patient Relevant Clinical Endpoints

1:45 PM — 2:45 PM

Addressing Challenges in Devices Safety Monitoring

1:45 PM — 2:45 PM

Africa's Evolving Regulatory Landscape

1:45 PM — 2:45 PM

AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research

1:45 PM — 2:45 PM

Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan

1:45 PM — 2:45 PM

EMA Town Hall

1:45 PM — 2:45 PM

Evolving Regulatory Considerations for Medical Affairs Communications

1:45 PM — 2:45 PM

Indonesia Town Hall

1:45 PM — 2:45 PM

Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success

1:45 PM — 2:45 PM

Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation

1:45 PM — 2:45 PM

Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?

1:45 PM — 2:45 PM

Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations

1:45 PM — 2:45 PM

Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe

1:45 PM — 2:45 PM

Potency Measurements for Cellular and Gene Therapy Products

1:45 PM — 2:45 PM

Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research

1:45 PM — 2:45 PM

Transforming Industry through Mentorship

1:45 PM — 2:45 PM

Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Drug Development

2:45 PM — 3:45 PM

Workshop: AI in Healthcare (Industry and Regulators)

4:00 PM — 5:00 PM

Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators

4:00 PM — 5:00 PM

Beyond Weight Loss: Pioneering the Future of Obesity Drug Development

4:00 PM — 5:00 PM

Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations

4:00 PM — 5:00 PM

Collaborating for Equity: Reaching Communities Through Partnerships with Federally Qualified Health Centers and Community Health Workers

4:00 PM — 5:00 PM

Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20

4:00 PM — 5:00 PM

Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders

4:00 PM — 5:00 PM

Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?

4:00 PM — 5:00 PM

Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels

4:00 PM — 5:00 PM

Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability

4:00 PM — 5:00 PM

Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders

4:00 PM — 5:00 PM

FDA Rare Disease Town Hall

4:00 PM — 5:00 PM

International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs

4:00 PM — 5:00 PM

Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development

4:00 PM — 5:00 PM

Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges

4:00 PM — 5:00 PM

Regulatory Perspectives on the Adoption of Advanced Manufacturing Technologies

4:00 PM — 5:00 PM

Successful Patient Input to Regulatory and Health Technology Assessment Processes Along the Development Path: Examples of How to Optimize Impact

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