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Monday, June 16
 

11:00am EDT

Accelerating Global Access to Drugs for Chronic Diseases

11:00am EDT

Moving Toward Pragmatism in Clinical Trials

11:00am EDT

Project Orbis: Six Years Later

11:00am EDT

Unintended Consequences: Effects of Inflation Reduction Act on the Future of Pharmaceutical Innovation

11:00am EDT

Advancing Innovation Through Essential Drug Delivery Outputs

11:00am EDT

Putting Patients First: Leveraging Global Identification of Medicinal Products Standards to Strengthen the Drug Supply Chain and Improve Lives

12:50pm EDT

CH: Regulatory Intelligence to Drive Regulatory Strategy

2:15pm EDT

FDA Legislation 2025: How is Congress Preparing to Advance Innovation, Medical Product Safety, and FDA Funding?

2:15pm EDT

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

2:15pm EDT

Health Canada Town Hall

2:15pm EDT

Setting the Bar High: Facilitating Quality and Acceptability of Decision-Grade Real-world Evidence

2:15pm EDT

Best Practices for Navigating Divergent Regulatory Feedback

3:45pm EDT

Applying Principles of Global Regulatory Collaboration to Address Chronic Disease

3:45pm EDT

FDA Accelerated Approval Program: Putting Withdrawals in Context

3:45pm EDT

Generative Artificial Intelligence in Regulatory Affairs: A Journey of Industry Implementation

3:45pm EDT

WHO Town Hall: Driving Innovation and Access - Global Collaboration in Medical Product Regulation

3:45pm EDT

Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders

3:45pm EDT

Spinning Plates and Juggling Chainsaws: Mastering the Art of Complex Project Management

3:45pm EDT

AI in Patient Care: Aspirations and Considerations
 
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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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  • Level
    Advanced
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    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
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Thursday, June 19
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
  • 15: Content-Hubs
  • 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