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Thursday, March 5, 2026
8:00 AM - 9:00 AM East Coast USA Time
Attendee Breakfast

8:00 AM - 5:00 PM East Coast USA Time
Registration Hours

9:00 AM - 10:00 AM East Coast USA Time
Opening Plenary: From Data to Decisions: The Expanding Role of Real‑World Evidence in Regulatory Submissions

10:00 AM - 10:30 AM East Coast USA Time
Coffee & Refreshment Break

10:30 AM - 11:30 AM East Coast USA Time
Biomedical Ethical Concerns of Artificial Intelligence-Driven Diagnosis in Precision Medicine

10:30 AM - 11:30 AM East Coast USA Time
Regulatory Intelligence in Motion: Embedding Strategic Value Across an Evolving Biopharma Enterprise

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

1:15 PM - 1:40 PM East Coast USA Time
Sponsored Presentation: Making Your SOTA and Device Literature Search Count: The Expectation Values of the Notified Bodies on Literature Searches

1:45 PM - 2:15 PM East Coast USA Time
Solutions Circle (3): AI to Securely Cut IND Assembly Time to Quality

1:45 PM - 2:15 PM East Coast USA Time
Solutions Circle (4): From Chaos to Compliance: Scaling MLR Systems for Global Readiness

1:45 PM - 2:15 PM East Coast USA Time
Solutions Circle (5): How Can a Strong Quality System Support Manufacturers’ Regulatory Strategy?

1:45 PM - 2:15 PM East Coast USA Time
Sponsored Solutions Circle (1): Modernizing Regulatory Information Management (RIM): From Legacy Systems to Data-Driven Operations

1:45 PM - 2:15 PM East Coast USA Time
Sponsored Solutions Circle (2): Best Practices for Compliance and Certification Road Mapping

2:30 PM - 3:30 PM East Coast USA Time
From Risk to Readiness: Lessons Learned in Medical Device Cybersecurity Documentation for FDA Submissions

2:30 PM - 3:30 PM East Coast USA Time
Gen AI Era: Evolving Landscape of Regulatory Affairs for Cell and Gene Therapy

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

5:00 PM - 6:00 PM East Coast USA Time
Opening Night Networking Reception

6:30 PM - 8:30 PM East Coast USA Time
Ticketed Networking Event: Leinie's Lodge and Beer Garden

Friday, March 6, 2026
8:00 AM - 9:00 AM East Coast USA Time
Networking Breakfast

8:00 AM - 12:00 PM East Coast USA Time
Registration Hours

8:30 AM - 9:00 AM East Coast USA Time
Solutions Circle (1): Navigating the Post-Market Cybersecurity Maze: Managing Vulnerabilities in Complex Medical Devices

8:30 AM - 9:00 AM East Coast USA Time
Solutions Circle (3): Global Regulatory Strategy for Orphan Early Stage Drug Development

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
Regulatory Challenges Demystified: Tips, Tools, and Expert Advice

12:00 PM - 1:00 PM East Coast USA Time
New Video Cybersecurity and Data Integrity in Cloud-Based Regulatory Submissions

12:00 PM - 1:00 PM East Coast USA Time
NEW Discussions on Critical Issues

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 Break

2:00 PM - 3:00 PM East Coast USA Time
Chasing an Easier Method for Specific PMPF: Can Surveys Play a Role?

2:00 PM - 3:00 PM East Coast USA Time
Integrated Approach to CTD Module 3 Submission for Drug-Device Combination Products

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: The Compliance Matrix: Futureproofing Regulatory Professionals in the Age of AI