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 TBD Diversity Action Plans in Rare Genetic Disease Drug Development: Obstacles and Opportunities TBD From Measuring to Modeling the Patient Burden: An Interactive Take on What Defines the Patient Experience in the AI-Age TBD Real-World Data Traceability: Challenges and Solutions When Generating Regulatory-Grade Data TBD Realizing Value Through Responsible AI in Clinical Trials TBD Revolutionizing Medical Writing: Evaluating and Building the Assistive Technology Ecosystem TBD Alphabet Soup: Utilization of Quality-by-Design and Risk-Based Quality Management in Clinical Trials Data Governance - A Multi-Regulator Inspection Perspective TBD International Harmonization in Real-World Evidence: Recent Efforts, Barriers and Future Enablers TBD Japan Town Hall TBD Redesigning Research and Development Policies with Women in Mind: Turning Ambition to Impact TBD

10:30am EDT

The Globalization of Risk Management TBD The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What? TBD Case Studies of Application of AI in Risk-Based Quality Management TBD Innovation Reimagined: How Intelligent Automation is Redefining Research and Development Excellence TBD Resilient Leadership: Overcoming Isolation and Adversity TBD Enhancing Sustained Diversity in Clinical Trials: A New Framework and Case Study for Community-Centered Collaborations TBD Participant Compensation in Clinical Trials: Exploring Today’s Landscape and Unlocking Opportunities TBD Innovative Regulatory Approaches for Developing Diagnostic Tests for Rare Biomarkers TBD Transforming the Project Management Role to Meet the Emerging Needs in Pharma: Extending Scope from R&D Focus to Launch Projects TBD FDA, MHRA, Health Canada Views on Data Flow: The Backbone of Effective Risk Assessments in Innovative Clinical Trial Design and Conduct TBD ANVISA Town Hall TBD Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development TBD US and EU Orphan Drug Regulations: Shaping the Ecosystem for Rare Diseases TBD Advancing a Global Regulatory Approach to Pharmaceutical Quality Knowledge Management TBD Bayesian Benefit-Risk Analysis: A Framework for Quantitative Evidence-Based Decision Making in Medical Product Development TBD Banishing Burnout: A Practice of Mindfulness Tools to Reduce Stress and Improve Well-Being TBD

1:45pm EDT

Real-World Evidence to Optimize Risk Minimization Programs: How to Move from Art to Science TBD Has Decentralized Trials Crashed, or Are We Just Getting Started? An Inflection Point for Clinical Operations in Oncology TBD Updating Ethics: What’s New (and why it Matters!) in the 2024 Declaration of Helsinki Revision TBD Reliable AI in Biomedical Settings: A Framework for Trust and Innovation in an Evolving Landscape TBD How Medical Writing Can Support Accelerating the Development of Rare Disease Therapies: Insights from the FDA’s START Program Pilot TBD Addressing Participation Burden in Clinical Trials: Evidence, Participant Feedback, and Signal Interpretation to Drive Impact TBD The Adoption of Artificial Intelligence and Machine Learning in Clinical Research TBD The Laboratory-Developed Tests Final Rule: New Developments and Compliance Insights TBD Forging a New Framework for Strategic Project Delivery: The Dynamic Phased Delivery Model TBD Embracing ICH E6(R3) with Risk-Based Quality Management and Data Governance TBD China Town Hall TBD Harmonizing Data Quality Frameworks: Bridging Regulatory Perspectives TBD Pediatric Cluster Town Hall TBD Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency TBD Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint TBD Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development TBD

4:00pm EDT

Advancing Premarketing Safety Analytics through FDA and Industry Partnerships TBD Overcoming Site Burden: Driving Adoption of Automation and End-to-End Integration TBD Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation TBD How Do We Get from Here to There: Putting Real-World Data Quality Assessments into Practice TBD Breaking Barriers: Making Health Information Accessible to All TBD Enhancing the Integration of Patient Experience in Assessing Treatment Tolerability TBD Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development TBD Delivering Effective Business Transformations and How to Apply them to Drug Development TBD Pharmacovigilance Inspector Fireside Chat TBD Updated Tufts Center for the Study of Drug Development Benchmarks on Vendor Qualification Practices: Insights from the Evolving Pharma Landscape TBD Enhancing Global Access to Innovative Therapies: Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products TBD Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance TBD Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk TBD Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies TBD Exploring Regulator Career Paths: The Impact of Diversity on Decision Making and Medicines Development TBD 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 TBD

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