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Monday, June 16
 

8:30am EDT

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

10:15am EDT

IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI TBD Lokavant, Inc Innovation Theater: Applying the Scientific Method to Clinical Trials: Building the Evidence for AI-Driven Transformation 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 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 Advancing Innovation Through Essential Drug Delivery Outputs TBD Putting Patients First: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives TBD

12:00pm EDT

Student Poster Session I EH

12:55pm EDT

PCM Trials Innovation Theater: Insights from Across the Care Continuum - How Community-Based Research Supports Trial Success TBD AlphaLife Science Innovation Theater: GenAI in Action - Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma TBD

1:35pm EDT

Evernorth Health Services Innovation Theater: Empowering Case Managers - Bridging Patient Education and Oncology Clinical Trial Enrollment TBD Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce TBD Taimei Technology Innovation Theater: Transforming eClinical Platform - The New Era of Agentic AI in Data and TMF Management TBD

2:15pm EDT

Expanding Innovative Master Protocol Trial Designs to Cell and Gene Therapies for Rare Diseases TBD A Masterclass: Patient Recruitment Campaign Management 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 International Regulatory Harmonization for Development of Medicines: A Look at How far We’ve Come and Where We Go From Here TBD Health Canada Town Hall TBD Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence TBD Best Practices for Navigating Divergent Regulatory Feedback 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 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 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 Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation TBD WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation TBD Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders TBD Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management 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
 
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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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    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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    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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  • Level
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  • Keyword
    Advanced Analytics
    Artificial Intelligence (AI)
    Bioethics
    Biomarkers
    Cell and Gene Therapy
    Clinical Trial Design
    Diagnostics
    Digital Technology
    Global Perspectives
    Non-CE
    Patient Experience
    Payers
    Pediatrics
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    Real-World Data (RWD) / Real-World Evidence (RWE)
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EH
TBD
Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming