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

11am – 12pm 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

Christelle Bouygues, PharmD.

Christelle Bouygues, PharmD.

Senior Regulatory Affairs Specialist, EMA

Sabina Van Hoekstra-van den Bosch, PharmD, FRAPS

Sabina Van Hoekstra-van den Bosch, PharmD, FRAPS

Global Director Regulatory Strategy Medical & Health Services, TÜV SÜD