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Wednesday, June 18
 

8:30am EDT

Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum

8:30am EDT

Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards

8:30am EDT

The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways

10:30am EDT

Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance

10:30am EDT

Practical Implementation of MRCTs Based on ICH E17 Guidelines

10:30am EDT

Navigating the Challenges of Drug Delivery Using a Novel Device

12:20pm EDT

CH: Addressing Key Challenges in Global Biosimilar Development and Regulation

1:45pm EDT

Africa's Evolving Regulatory Landscape

1:45pm EDT

EMA Town Hall

1:45pm EDT

Indonesia Town Hall

1:45pm EDT

Evolving Regulatory Considerations for Medical Affairs Communications

1:45pm EDT

Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success

2:55pm EDT

Roundtable Discussion: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products

2:55pm EDT

Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability

4:00pm EDT

International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs

4:00pm EDT

Beyond Weight Loss: Pioneering the Future of Obesity Drug Development

4:00pm EDT

FDA Rare Disease Town Hall

4:00pm EDT

Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20

4:00pm EDT

Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators
 
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    00: Plenary
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    01: ClinSafety-PV
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    02: ClinTrials-Ops
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    Tutorial
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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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    Tutorial
    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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  • 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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Monday, June 9
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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
  • 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