“Just returned from the Extractables & Leachables Summit, and it was a truly insightful and inspiring experience! A big thank you to Pharma ED Resources, Inc. and Kim Hubbard for organizing a well-structured event with a uniquely warm and engaging atmosphere.”

~ Biocompatibility & Material Science Specialist, Gerresheimer

Event Summary

This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. We will focus closely on the keys to satisfying recent revisions to several applicable USP chapters, FDA guidances & other international regulatory requirements for best practices in materials and chemistry characterization for drugs, biologics, delivery systems, and primary & secondary packaging.

Why Attend:

• Two full days of presentations, panel discussions, and networking
• The industry’s top experts share their knowledge and lessons learned
• Learn what you need to know to meet regulatory expectations for E/Ls in drug products, delivery systems, medical devices, and packaging
• Focus on overcoming common analytical challenges in E/L study design
• Gain insight into AET’s and uncertainty factors in E/L analysis
• Explore E&L Assessment in Cell & Gene Therapies

What People Are Saying about Pharma Ed’s Extractables & Leachables Annual Summit!

Pharma Ed’s Extractables & Leachables West 2025 is Sponsored by:

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