DIA 2025 Global Annual Meeting

DIA 2025 Global Annual Meeting

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8:30am EDT

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

8:30am EDT

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

8:30am EDT

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

8:30am EDT

Realizing Value Through Responsible AI in Clinical Development

8:30am EDT

Revolutionizing Medical Writing: Evaluating and Building the Assistive Technology Ecosystem

8:30am EDT

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

8:30am EDT

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

8:30am EDT

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

8:30am EDT

Japan Town Hall

8:30am EDT

MHRA Town Hall

8:30am EDT

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

8:30am EDT

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

9:45am EDT

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

9:45am EDT

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

9:45am EDT

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

10:30am EDT

The Globalization of Risk Management

10:30am EDT

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

10:30am EDT

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

10:30am EDT

Resilient Leadership: Overcoming Isolation and Adversity

10:30am EDT

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

10:30am EDT

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

10:30am EDT

Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers

10:30am EDT

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

10:30am EDT

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

10:30am EDT

ANVISA Town Hall

10:30am EDT

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

10:30am EDT

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

10:30am EDT

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

10:30am EDT

Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management

10:30am EDT

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

10:30am EDT

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

11:30am EDT

Professional Poster Session II

11:40am EDT

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

11:45am EDT

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

12:00pm EDT

Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease

12:00pm EDT

Roundtable Discussion: Building a Regulatory Landscape to Support CMC Innovation

12:20pm EDT

CH: Diversity Action Plans - Listen, Learn, and Execute

12:25pm EDT

Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies

1:00pm EDT

CH: Navigating AI Regulation in Pharma - Global Trends, Compliance Challenges, and Harmonization Efforts

1:05pm EDT

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

1:45pm EDT

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

1:45pm EDT

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

1:45pm EDT

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

1:45pm EDT

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

1:45pm EDT

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

1:45pm EDT

The Adoption of Artificial Intelligence and Machine Learning in Clinical Research

1:45pm EDT

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

1:45pm EDT

US Executive Orders: Impact on Precision Medicine and Diagnostic Development

1:45pm EDT

Guerrilla Strategic Delivery

1:45pm EDT

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

1:45pm EDT

Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives

1:45pm EDT

Pediatric Cluster Town Hall

1:45pm EDT

China Town Hall

1:45pm EDT

Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency

1:45pm EDT

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

1:45pm EDT

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

2:55pm EDT

Roundtable Discussion: Alphabet Soup - Utilization of Quality by Design and Risk Based Quality Management in Clinical Trials Data Goverernance

2:55pm EDT

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

3:00pm EDT

CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development

3:00pm EDT

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

3:00pm EDT

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

3:00pm EDT

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

4:00pm EDT

Advancing Premarketing Safety Analytics through FDA and Industry Partnerships

4:00pm EDT

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

4:00pm EDT

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

4:00pm EDT

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

4:00pm EDT

Breaking Barriers: Making Health Information Accessible to All

4:00pm EDT

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

4:00pm EDT

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

4:00pm EDT

New Data and Insights on the Vendor Qualification Process in Drug Development

4:00pm EDT

Pharmacovigilance Inspections Fireside Chat

4:00pm EDT

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

4:00pm EDT

Towards Instantaneous Regulatory Decisions and Better Predictability

4:00pm EDT

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

4:00pm EDT

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

4:00pm EDT

Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies

4:00pm EDT

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

4:00pm EDT

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

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Jun 9 - 19, 2025

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Washington, D.C., USA

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00: Plenary

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01: ClinSafety-PV

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02: ClinTrials-Ops

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03: Data-Tech

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04: MedAffairs-SciComm

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05: Patient-Impact-Product-Dev

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06: PersonalizedMed-ComboProd-Diagnostics

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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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13: Spotlight

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14: DIAmond

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15: Content-Hubs

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16: Community-Rounds

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17: Posters

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18: InnovationTheaters

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20: Short-Courses

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Advanced Analytics

Artificial Intelligence (AI)

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Clinical Trial Design

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Non-CE

Patient Experience

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Real-World Data (RWD) / Real-World Evidence (RWE)

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