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Coming Soon · WEBINAR 02
The EU-FDA Gap: What European Biotechs Need to Know Before They File
European biotechs expanding to the US consistently underestimate FDA's requirements. EMA approval does not transfer. This session covers the three gaps that cost companies 12–24 months — and how to close them before they become delays.
What You Will Learn
- —The three EU to FDA gaps that cost European biotechs 12 to 24 months — and why EMA approval does not transfer.
- —How CMC, clinical, and nonclinical expectations diverge between the agencies, with concrete examples.
- —A practical sequencing plan to close the gaps before you file, not after FDA flags them.
Who This Is For
European biotech founders, VP Regulatory, CSOs expanding to the US
Format
45-minute session + 15-minute Q&A
Date
To be confirmed — reserve your spot to be notified.