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Full Schedule

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Full Schedule

  • Wednesday, June 5, 2024
  • 8:00 AM – 9:00 AM EDT
    Workshop Breakfast
  • 8:00 AM – 4:00 PM EDT
    Registration
  • 9:00 AM – 4:00 PM EDT
    Locating and Analyzing Regulatory Precedent for Drugs and Biologics
  • 10:30 AM – 11:00 AM EDT
    Coffee Break
  • 12:00 PM – 1:00 PM EDT
    Workshop Lunch
  • 2:30 PM – 3:00 PM EDT
    Coffee Break
  • Thursday, June 6, 2024
  • 8:00 AM – 9:00 AM EDT
    Breakfast - Sponsored by Cedience
  • 8:00 AM – 5:00 PM EDT
    Registration
  • 9:00 AM – 10:15 AM EDT
    Opening Plenary: Preparing for the Next Round of User Fee Negotiations
  • 10:15 AM – 10:45 AM EDT
    Coffee Break
  • 10:45 AM – 11:45 AM EDT
    A Strategic Approach: Best Practices for Commenting on Draft FDA Guidance Documents for Drug and Device Companies
  • 10:45 AM – 11:45 AM EDT
    Driving Strategic Value: Establishing KPIs to Advocate for a Dedicated Regulatory Policy & Intelligence Team in Drug and Device Companies
  • 11:55 AM – 12:55 PM EDT
    Mastering the Art of Communication: Enhancing Regulatory Policy & Intelligence Dissemination within Drug and Device Organizations
  • 11:55 AM – 12:55 PM EDT
    Staying Ahead of the Curve: The Nuts and Bolts of Monitoring and Disseminating External Regulatory Agency News and Publications in Drug and Device Companies
  • 1:00 PM – 2:30 PM EDT
    Lunch - Sponsored by Freyr
  • 2:30 PM – 3:30 PM EDT
    Advancing Policy Initiatives: The Regulatory Policy Value of Drug and Device Companies' Participation in Trade Associations and Industry Consortia
  • 2:30 PM – 3:30 PM EDT
    Paving Your Path in Regulatory Policy & Intelligence: Skill Development and Transition Strategies for Drug and Device Professionals
  • 3:30 PM – 4:00 PM EDT
    Coffee Break
  • 4:00 PM – 5:00 PM EDT
    Homegrown Regulatory Intelligence Tools in the Drugs and Biologics Space
  • 4:00 PM – 5:00 PM EDT
    Medical Device Hot Topics and Troubleshooting Q&A
  • 5:00 PM – 6:00 PM EDT
    Networking Reception - Sponsored by InfoDesk
  • Friday, June 7, 2024
  • 8:00 AM – 9:00 AM EDT
    Breakfast
  • 8:00 AM – 12:00 PM EDT
    Registration
  • 9:00 AM – 10:00 AM EDT
    Navigating the Complex Landscape: Understanding the Impact of New Guidance and Laws on Drug Development Companies
  • 9:00 AM – 10:00 AM EDT
    Navigating the Complex Landscape: Understanding the Impact of New Guidance and Laws on Medical Device Companies
  • 10:00 AM – 10:30 AM EDT
    Coffee Break
  • 10:30 AM – 11:30 AM EDT
    Designing and Maintaining a Robust Regulatory Intelligence Program
  • 10:30 AM – 11:30 AM EDT
    Hidden Gems: Discovering Regulatory Intelligence Within Your Records
  • 11:40 AM – 12:40 PM EDT
    Harnessing Regulatory Intelligence: Supporting Drug Regulatory Strategies Across the Product Lifecycle
  • 11:40 AM – 12:40 PM EDT
    Harnessing Regulatory Intelligence: Supporting Medical Device Development and Approval Pathway Strategies
  • 12:40 PM – 1:45 PM EDT
    Lunch
  • 1:45 PM – 2:45 PM EDT
    Closing Plenary: Embracing the Digital Revolution: Applying AI and ML Technology within the Regulatory Policy & Intelligence Functions of Drug and Device Companies