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Full Schedule

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Full Schedule

  • Wednesday, March 4, 2026
  • 8:00 AM - 9:00 AM East Coast USA Time
    Workshop Breakfast
  • 9:00 AM - 4:00 PM East Coast USA Time
    Pre-Conference Workshop: Spelling out PCCP's
  • 1:00 PM - 2:00 PM East Coast USA Time
    Workshop Lunch Break
  • Thursday, March 5, 2026
  • 8:00 AM - 9:00 AM East Coast USA Time
    Networking Breakfast
  • 9:00 AM - 10:00 AM East Coast USA Time
    Opening Plenary: RWE & RWD
  • 10:00 AM - 10:30 AM East Coast USA Time
    Coffee & Refreshment Break
  • 10:30 AM - 11:30 AM East Coast USA Time
    The Compliance Matrix: Futureproofing Regulatory Professionals in the Age of AI
  • 10:30 AM - 11:30 AM East Coast USA Time
    When the Model Becomes the Molecule: Regulating AI in Drug Development
  • 10:45 AM - 12:45 PM East Coast USA Time
    From Change to Clearance: Leveraging Predetermined Change Control Plans to Accelerate Regulatory Approvals and Innovation
  • 11:45 AM - 12:45 PM East Coast USA Time
    Regulatory Considerations and Strategies for the Use of Artificial Intelligence in US Advertising and Promotion
  • 12:45 PM - 1:45 PM East Coast USA Time
    Lunch and Sponsored Presentations
  • 1:45 PM - 2:15 PM East Coast USA Time
    Solutions Circle: AI to Securely Cut IND Assembly Time to Quality - Expert Panel on Case Studies
  • 1:45 PM - 2:15 PM East Coast USA Time
    Solutions Circle: From Chaos to Compliance: Scaling MLR Systems for Global Readiness
  • 1:45 PM - 2:15 PM East Coast USA Time
    Solutions Circle: Global Regulatory Strategy for Orphan and Early-Stage Drug Development: Aligning IND and IMPD Pathways
  • 2:30 PM - 3:30 PM East Coast USA Time
    Evolving Landscape of Regulatory Affairs for Cell and Gene Therapy
  • 2:30 PM - 3:30 PM East Coast USA Time
    From Risk to Readiness: Lessons Learned in Medical Device Cybersecurity Documentation for FDA Submissions”
  • 3:30 PM - 4:00 PM East Coast USA Time
    Afternoon Refreshment Break
  • 4:00 PM - 5:00 PM East Coast USA Time
    From Nonconformities to Insight: Leveraging Biocompatibility Assessment Trends for Regulatory Intelligence and Strategic Compliance
  • 4:00 PM - 5:00 PM East Coast USA Time
    Reimagining Global Regulatory Strategy for Agility and Impact
  • 6:00 PM - 7:00 PM East Coast USA Time
    Opening Night Networking Reception
  • Friday, March 6, 2026
  • 8:00 AM - 9:00 AM East Coast USA Time
    Networking Breakfast
  • 8:30 AM - 9:00 AM East Coast USA Time
    Solutions Circle: How Can a Strong Quality System Support a Manufacturer's Regulatory Strategy?
  • 8:30 AM - 9:00 AM East Coast USA Time
    Solutions Circle: Managing the Lifecycle for Artificial Intelligence in Medicine
  • 8:30 AM - 9:00 AM East Coast USA Time
    Solutions Circle: Navigating the Post-Market Cybersecurity Maze: Managing Vulnerabilities in Complex Medical Devices
  • 9:15 AM - 10:15 AM East Coast USA Time
    From Insight to Impact: A Practical Guide to Reviewing and Shaping Regulatory Guidance
  • 9:15 AM - 10:15 AM East Coast USA Time
    QMS for Adaptive AI/ML Devices: What You Can’t Miss
  • 10:15 AM - 10:45 AM East Coast USA Time
    Coffee & Refreshment Break
  • 10:45 AM - 11:45 AM East Coast USA Time
    Devices that Help: Demystifying the Regulatory Expectations Around Showing “Benefit”
  • 10:45 AM - 11:45 AM East Coast USA Time
    No Site, No Problem? Regulating Evidence in a Decentralized Trial World
  • 12:00 PM - 1:00 PM East Coast USA Time
    Cybersecurity and Data Integrity in Cloud-Based Regulatory Submissions
  • 12:00 PM - 1:00 PM East Coast USA Time
    Global registration planning consideration: Integrated strategy to solve the complex registration sample challenge
  • 1:00 PM - 2:00 PM East Coast USA Time
    Lunch and Sponsored Presentations
  • 2:00 PM - 3:00 PM East Coast USA Time
    Integrated Approach to CTD Module 3 Submission for Drug-Device Combination Products
  • 2:00 PM - 3:00 PM East Coast USA Time
    New Session Topic: Post-Market Performance Follow-up & Post-Market Surveillance
  • 3:00 PM - 3:30 PM East Coast USA Time
    Afternoon Refreshment Break
  • 3:30 PM - 4:30 PM East Coast USA Time
    Closing Plenary: Biomedical Ethical Concerns of Artificial Intelligence-Driven Diagnosis in Precision Medicine