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Full Schedule

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*Program and presenters are subject to change. Please check back frequently for updates.

Full Schedule

  • 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