Extractables & Leachables West 2025

Extractables & Leachables West 2025 is organized by PharmaEd Resources, Inc. and will be held from Nov 04 - 05, 2025 at Sheraton La Jolla Hotel, La Jolla, California, United States of America.

Theme: Quality, Safety, Biocompatibility & Regulatory Compliance for Drugs, Biologics, & Med Devices

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