DIA 2025 Global Annual Meeting

DIA 2025 Global Annual Meeting

1:00pm EDT

12P: Real-World Evidence: Navigating the Evolving Landscape of Regulation, Data, and Integration TBD

9:30am EDT

21A: Risk-Based Quality Management in Action: Hands-On with a Real Study Protocol TBD

1:00pm EDT

22P: Accelerating Breakthroughs: Project Management Strategies in Drug Development Virtual

9:30am EDT

31A: Cell and Gene Therapies 101: Specific Regulatory, CMC, Non-Clinical, and Clinical Requirements and Considerations TBD

1:00pm EDT

32P: Introduction to Artificial intelligence (AI) Regulations and Governance for Life Sciences TBD

9:30am EDT

41A: Talking Statistics: Interpreting Statistical Results for Non-Statisticians Involved with Clinical Trials TBD

1:00pm EDT

42P: Regulatory Strategy Development for Complex Devices and Combination Products TBD

9:00am EDT

62F: Electronic Patient-Reported Outcomes (ePRO): An Implementation Masterclass TBD 61F: Root Cause Analysis and CAPA Management: Your Essential Toolkit for Best Practices TBD

11:00am EDT

A Regulator's View on the Future Vision for Pharmacovigilance TBD Advancing Clinical Outcomes through Digital Health Technology Innovation TBD Is Real-World Evidence Always a Last Resort? TBD From Approval to Access: Integrating Patient Insights into Coverage Decisions TBD Advancing Innovation through Essential Drug Delivery Design Outputs TBD Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized TBD Moving Toward Pragmatism in Clinical Trials TBD Project Orbis: Six Years Later TBD Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation TBD The Role of Identification of Medicinal Products in the Future of Global Healthcare TBD

2:15pm EDT

A Masterclass: Patient Recruitment Campaign Management TBD Expanding Basket Trials to Cell and Gene Therapies for Rare Diseases TBD Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence TBD Divergent Regulations and a Call for Regulatory Harmonization TBD Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion TBD Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine TBD Models of Collaborations to Advance Regulatory Science: Lessons Learned TBD Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management TBD FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding? TBD Health Canada Town Hall TBD International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here TBD Building a Regulatory Landscape to Support CMC Innovation TBD Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights TBD Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge TBD Ushering in a New Era of Africa Healthcare TBD

3:45pm EDT

Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting TBD Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials TBD Efficient Data Exchange: Drivers for End-to-End Standards Adoption TBD Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders TBD Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience TBD How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development TBD Ethics in the Era of Precision Medicine and Advancing Technologies TBD Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management TBD Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How TBD Applying Principles of Global Regulatory Collaboration to Address Chronic Disease TBD FDA Accelerated Approval Program: Putting Withdrawals in Context TBD Generative Intelligence in Regulatory Affairs: A Journey of Industry Implementation TBD WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation TBD Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C TBD Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication TBD AI in Patient Care: Aspirations and Considerations TBD

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

8:30am EDT

Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime? TBD From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care TBD Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities TBD Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Efficiencies and Regulatory Review TBD Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives TBD How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance TBD Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges TBD Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report TBD

10:30am EDT

From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14 TBD Trustworthy AI Solutions for Next-Generation Pharmacovigilance TBD Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa TBD Patient Referral: Is It Hope or Hype? TBD Research in Participants with Progressive Cognitive Impairment: Best practices for ensuring continuing informed consent TBD Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development TBD Leveraging AI and Structured Content Authoring Tools in Regulatory Medical Writing: A 1-Year Look TBD Why Patient Involvement is a Must Have to Ensure Accessibility to Digital Health Technologies and Development of Patient Relevant Clinical Endpoints TBD Navigating the Challenges of Drug Delivery Using a Novel Device TBD Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development TBD Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality TBD Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance TBD Practical Implementation of MRCTs Based on ICH E17 Guidelines TBD Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval TBD Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health TBD Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance TBD

1:45pm EDT

Addressing Challenges in Devices Safety Monitoring TBD AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research TBD Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan TBD ICH Pharmaceutical Quality Knowledge Management Platform Global Regulatory Assessment and Industry-Vision to Reality TBD Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe TBD Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research TBD Evolving Regulatory Considerations for Medical Affairs Communications TBD Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations TBD Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go? TBD Africa's Evolving Regulatory Landscape TBD EMA Town Hall TBD Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success TBD Potency Measurements for Cellular and Gene Therapy Products TBD Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Medical Product Development TBD Transforming Industry through Mentorship TBD

2:45pm EDT

Workshop: AI in Healthcare (Industry and Regulators) TBD

4:00pm EDT

Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels TBD Examining Bias in Lung Cancer Study Protocols: Lessons Learned TBD Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now? TBD Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges TBD Collaborating for Equity: The FDA OMHHE REACH Consortium's Partnership with Federally Qualified Health Centers and Community Health Workers TBD Successful Patient Input to Regulatory and Health Technology Assessment Processes Along the Development Path: Examples of How to Optimize Impact TBD Quality Briefs from Inception to Operationalization: How to Engage Internal Stakeholders TBD Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators TBD Beyond Weight Loss: Pioneering the Future of Obesity Drug Development TBD FDA Rare Disease Town Hall TBD International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs TBD Regulatory Perspectives on the Adoption of Advanced Manufacturing Technologies TBD Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20 TBD Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development TBD Business Agility: Applying Strategic and Critical Thinking to Recognize Global Business Environment and Adopt Strategies TBD

9:00am EDT

Implementing the Aggregate Safety Assessment Planning and Aggregate Safety Review with an Interactive Application: Learnings and Enhancements TBD Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders TBD How AI is Transforming the Area of Data Standards and Access to Source Data TBD Embedding and Leveraging AI for Quality and Compliance in Pharma TBD EMA - FDA Question Time TBD Beyond the Frequentist Approach in Hard to Recruit Populations: Acceptance of Bayesian Methods for Registration/Pivotal Trial TBD Bridging Science and Business: A Roadmap from Pharmaceutical Research to Successful Entrepreneurship TBD

10:30am EDT

FDA Town Hall TBD

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