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Ask the Experts: Navigating FDA & EMA CMC Expectations for Cell and Gene Therapy Product Development
Live date: 17:00 CET Mar 13th, 2025
Join our CMC regulatory experts as they share firsthand insights on FDA and EMA expectations for cell and gene therapy (CGT) product development. Drawing from extensive experience across multiple projects and direct interactions with regulatory agencies, our experts will discuss key feedback trends, common challenges, and best practices for a smooth regulatory pathway.
Questions will include:
- How do FDA and EMA expectations differ for CGT CMC requirements?
- How should companies approach regulatory interactions to optimize feedback?
- What are the key elements of a robust CMC strategy for early-stage development?
Don’t miss this opportunity to gain practical, real-world knowledge to optimize your CMC strategy and accelerate your CGT program.
Register for this webinar now
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Ask the Experts: Navigating FDA & EMA CMC Expectations for Cell and Gene Therapy Product Development
13/3/20255:00pm CET1 hour
Join our CMC regulatory experts as they share firsthand insights on FDA and EMA expectations for cell and gene therapy (CGT) product development. Drawing from extensive experience across multiple projects and direct interactions with regulatory agencies, our experts will discuss key feedback trends, common challenges, and best practices for a smooth regulatory pathway. Questions will include:
- How do FDA and EMA expectations differ for CGT CMC requirements?
- How should companies approach regulatory interactions to optimize feedback?
- What are the key elements of a robust CMC strategy for early-stage development?
Don't miss this opportunity to gain practical, real-world knowledge to optimize your CMC strategy and accelerate your CGT program.