Fireside Chat: What Regulators and Notified Bodies Want to See – A First-Hand Perspective

11:30am – 12:30pm EST, 11 December 2026 ‐ 1 hour

Global Perspectives, Practical Insights and Exercises

Designing a Cross-regional Development and Regulatory Plan OR Fire-chat: What Regulators and Notified Bodies Want to See – 1st Hand Perspective Notified Bodies

Speakers

James Bertram

Director, Office of Combination Products, FDA