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Full Schedule

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Full Schedule

  • Monday, March 10, 2025
  • 8:00 AM – 9:00 AM EST
    Breakfast
  • 9:00 AM – 4:00 PM EST
    Regulatory Maestro! The Role of an Effective Global Regulatory Lead
  • 10:30 AM – 11:00 AM EST
    Refreshments Break
  • 12:00 PM – 1:00 PM EST
    Lunch
  • 2:30 PM – 3:00 PM EST
    Refreshments Break
  • Tuesday, March 11, 2025
  • 8:00 AM – 9:00 AM EST
    Breakfast
  • 8:00 AM – 5:00 PM EST
    Registration
  • 9:00 AM – 10:15 AM EST
    Opening Plenary: AI in Regulatory Science - Past, Present and Future
  • 10:15 AM – 10:45 AM EST
    Coffee and Refreshments Break
  • 10:45 AM – 11:45 AM EST
    AI Governance in Healthcare: A Cross-Jurisdictional Global Analysis of Regulatory Approaches
  • 10:45 AM – 11:45 AM EST
    Strategic Authoring in Clinical Study Reports to Leverage AI for Data Privacy and Public Disclosure
  • 11:55 AM – 12:55 PM EST
    Just How Minimal Can Minimal Manipulation Be to Remain Minimal
  • 11:55 AM – 12:55 PM EST
    Mastering Intended Use for Complex and Emerging Medical Technologies
  • 12:55 PM – 2:25 PM EST
    Lunch.
  • 1:45 PM – 2:15 PM EST
    Table 1: Solutions Circle: AI and Drug Development: Regulatory Perspective
  • 1:45 PM – 2:15 PM EST
    Table 2: Solutions Circle: Applying a Risk-Based Approach to AI: Risk Management for AI in Drug Development, IVDs, and SaMD
  • 1:45 PM – 2:15 PM EST
    Table 3: Solutions Circle: De-risking regulatory strategy with evidence-driven insights from across the global landscape, powered by AI
  • 1:45 PM – 2:15 PM EST
    Table 4: Solutions Circle: Designing Clinical Trials for Complex and Branded Generics - Global Development Challenges and Mitigation Strategy
  • 1:45 PM – 2:15 PM EST
    Table 5: Solutions Circle: Establishing and Maintaining the Right Level of Clinical Evidence Under the EU IVDR
  • 1:45 PM – 2:15 PM EST
    Table 6: Solutions Circle: Finding a Path to Yes: Demonstrating the Value of Regulatory Affairs
  • 1:45 PM – 2:15 PM EST
    Table 7: Solutions Circle: Impending Product Shortages and Potential Changes from the European Commission
  • 1:45 PM – 2:15 PM EST
    Table 8: Solutions Circle: Optimizing Probability of Technical and Regulatory Success Leveraging Precedent Intelligence through Digital and AI
  • 1:45 PM – 2:15 PM EST
    Table 9: Solutions Circle: Strategies to Incorporate Conflicting Notified Body Feedback During MDR Review and Minimize Registration Impact
  • 2:25 PM – 3:25 PM EST
    It’s all in the Label: Leveraging Labels to drive regulatory, clinical and commercial strategy
  • 2:25 PM – 3:25 PM EST
    Structured methods for a robust benefit risk assessment throughout the device lifecycle
  • 3:35 PM – 4:35 PM EST
    Bridging the Gap from Product Development to Pivotal IDE Study Readiness
  • 3:35 PM – 4:35 PM EST
    Diversity in Clinical Trials: An Analysis of FDA Guidances to Inform Best Practices
  • 4:35 PM – 5:50 PM EST
    Coffee and Refreshments Break
  • 4:50 PM – 5:50 PM EST
    Practical and Comparative Analysis of CDS Software Regulations in the US and LATAM
  • 4:50 PM – 5:50 PM EST
    Strategic Considerations for Joint Review Procedures of CTAs – Lessons Learned from EU and Africa
  • 6:00 PM – 7:00 PM EST
    Opening Night Networking Reception
  • Wednesday, March 12, 2025
  • 8:00 AM – 9:00 AM EST
    Breakfast
  • 8:00 AM – 4:00 PM EST
    Registration
  • 9:00 AM – 10:00 AM EST
    EU Pharmaceutical Legislation Update
  • 9:00 AM – 10:00 AM EST
    Story Building Your Submissions for Improved Collaboration With Reviewers and Cross-Functional Team Members
  • 10:00 AM – 10:30 AM EST
    Coffee and Refreshments Break
  • 10:30 AM – 11:30 AM EST
    Recent Trends in US and EU Health Authority Comments
  • 10:30 AM – 11:30 AM EST
    The Twisting and Turning of the EU Legislation on Medical Devices and IVDs
  • 11:40 AM – 12:40 PM EST
    Regulatory Data: Warning Letter Trends and Insights
  • 11:40 AM – 12:40 PM EST
    Throughout the Product Lifecycle: EU IVDR Compliance Beyond Certification
  • 12:40 PM – 1:40 PM EST
    Lunch Break
  • 1:40 PM – 2:40 PM EST
    ATMPs and CGTs – Nonclinical and CMC Regulatory Challenges
  • 1:40 PM – 2:40 PM EST
    From Development to Market: Validation and Updates for CDS Software
  • 2:40 PM – 3:00 PM EST
    Coffee and Refreshments Break
  • 3:00 PM – 4:00 PM EST
    Closing Plenary: Bringing it all Together: Adapting Regulatory Strategies to the Evolving Landscape