Planning Early for European Market Entry: Navigating Regulatory & Access Differences Between the US & EU

• Highlight the importance of early strategic planning for US biotechs expanding into Europe to avoid rushed launches and regulatory setbacks
• Compare FDA prerequisites and EMA expectations to identify critical divergences that can impact timelines and trial readiness
• Discuss market access procedures and lessons learned from companies like Cabaletta on how to successfully prepare for European entry

Speakers:

Leon Stross

Executive Director - Medical Affairs & New Product Planning

Cabaletta Bio