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10:15am • Lokavant, Inc Innovation Theater: Applying the Scientific Method to Clinical Trials: Building the Evidence for AI-Driven Transformation
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10:15am • IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI
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11:00am • A Regulator's View on the Future Vision for Pharmacovigilance
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11:00am • Why do Good Clinical Practice Inspectors Do Things Differently and How can Approaches be Both Harmonized and Optimized
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11:00am • Putting Patients First: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives
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11:00am • From Approval to Access: Integrating Patient Insights into Coverage Decisions
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11:00am • Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation
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11:00am • Is Real-World Evidence Always a Last Resort?
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11:00am • Advancing Innovation Through Essential Drug Delivery Outputs
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11:00am • Moving Toward Pragmatism in Clinical Trials
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11:00am • Project Orbis: Six Years Later
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11:00am • Advancing Clinical Outcomes through Digital Health Technology Innovation
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11:00am • Accelerating Global Access to Drugs for Chronic Diseases
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12:10pm • CH: Leading Teams Through Organizational Change and Layoffs - Best Practices for Change Management
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12:50pm • CH: Regulatory Intelligence to Drive Regulatory Strategy
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12:55pm • PCM Trials Innovation Theater: Insights from Across the Care Continuum - How Community-Based Research Supports Trial Success
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12:55pm • AlphaLife Science Innovation Theater: GenAI in Action - Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma
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1:30pm • CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
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1:35pm • Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce
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1:35pm • Taimei Technology Innovation Theater: Transforming eClinical Platform - The New Era of Agentic AI in Data and TMF Management
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1:35pm • Evernorth Health Services Innovation Theater: Empowering Case Managers - Bridging Patient Education and Oncology Clinical Trial Enrollment
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2:15pm • Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management
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2:15pm • Models of Collaborations to Advance Regulatory Science: Lessons Learned
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2:15pm • FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding?
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2:15pm • Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases
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2:15pm • Clinical Care vs Research: Walking the Ethical Tightrope Between Advocacy and Coercion
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2:15pm • Health Canada Town Hall
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2:15pm • A Masterclass: Patient Recruitment Campaign Management
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2:15pm • Best Practices for Navigating Divergent Regulatory Feedback
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2:15pm • International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here
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2:15pm • Ushering in a New Era of Africa Healthcare
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2:15pm • Leveraging the Capabilities of Artificial Intelligence and Digital Pathology in Precision Medicine
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2:15pm • Tech-Enabled Clinical Development: Public Sector Innovation Leading the Charge
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2:15pm • Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence
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2:15pm • Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights
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2:15pm • Building a Regulatory Landscape to Support CMC Innovation
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3:45pm • AI in Patient Care: Aspirations and Considerations
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3:45pm • Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation
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3:45pm • Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
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3:45pm • Enhancing Evidence Generation Across Pharmaceutical Life Cycle: The Importance of Integrating the Patient Lived Experience
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3:45pm • Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication
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3:45pm • Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management
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3:45pm • Ethics in the Era of Precision Medicine and Advancing Technologies
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3:45pm • Efficient Data Exchange: Drivers for End-to-End Standards Adoption
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3:45pm • Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
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3:45pm • WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation
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3:45pm • Advances in Clinical Trial Linkage to Real-World Data: Bridging the Gap in Hybrid Clinical Trials
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3:45pm • Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C
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3:45pm • Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders
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3:45pm • How Soon is Too Soon? Enhancing Early Regulatory Engagement and Harmonization to Streamline Patient-Focused Drug Development
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3:45pm • Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting
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3:45pm • FDA Accelerated Approval Program: Putting Withdrawals in Context
