Biotech innovation moves fast — but regulatory strategy often lags behind. If you’re building toward your first CTA or IND, you need more than good intentions. You need clarity on what agencies expect, how to engage them, and when to act.
This webinar is designed for biotech founders, CEOs, and early-stage teams looking to sharpen their regulatory approach before it becomes a bottleneck.
Here’s what you’ll learn:
- Who and how – Understanding guidelines and using reviews to your advantage
- Scientific advice – When to ask, what to ask, and how to prepare
- Regulatory procedures – SME status, orphan designation, CTA and IND essentials
This session is built for startups. We’ll keep it sharp, practical, and focused on what you can act on now.
- Date: June 5th
- Time: 16:00 – 16:45 CET
Speaker:
- Maria Ana Gomez Ferreria – Senior Regulatory Affairs Specialist: Maria Ana holds a PhD in Molecular Biology and has an international background as a scientist in both the US and Canada. She later served as R&D Director at a biotech company in Barcelona, where she led early-stage oncology drug development. For the past ten years, she has worked as a regulatory consultant, supporting biotech startups through the early development of a wide range of products, including cell and gene therapies. Her expertise spans scientific advice procedures, clinical trial applications, and strategic regulatory planning for first-in-human studies.
Reserve your spot and prepare to make regulatory strategy one of your strengths.
