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Interview with NAMSA

Featuring Sheri KrajewskiSenior Global Product Marketing Manager, Biological Evaluation of Medical Devices at NAMSA. She previews the medical device session and panel she will moderate on Day 2 of E&L US 2026.

Q: Why was it important for NAMSA to help shape and host this particular session on chemical characterization?

Smithers brings together a highly technical, engaged audience, which makes this collaboration particularly valuable. It allows NAMSA to contribute directly to meaningful industry dialogue and to share practical insights drawn from real regulatory and scientific challenges our clients face.

Q: Why is this topic especially timely for the industry right now?

Regulatory expectations around materials, extractables, and leachables continue to be challenging, while development timelines are tightening. Many organizations are also reassessing legacy data and strategies, making this a very relevant moment to step back and discuss best practices.

Q: From a technical perspective, what is one key challenge or question in chemical characterization and E&L that you expect the panel to explore?

A key challenge is how to appropriately utilize chemical characterization and E&L strategies while balancing scientific rigor, regulatory expectations, and practical constraints. And the focus still needs to remain to create data that meaningfully supports patient safety, our whole purpose.

Q: NAMSA has been a long-time partner of the conference — what makes this collaboration with Smithers valuable for you and your team?

Smithers brings together a highly technical, engaged audience, which makes this collaboration particularly valuable. It allows NAMSA to contribute directly to meaningful industry dialogue and to share practical insights drawn from real regulatory and scientific challenges our clients face.

Q: For delegates considering attending, what are the key reasons they shouldn’t miss this event?

Attendees will gain practical, immediately applicable insights around E&L strategy, regulatory expectations, or common pitfalls. Just as importantly, it’s a strong forum for peer-to-peer discussion with people who truly understand the space.