Extractables & Leachables Summit 2024
Extractables & Leachables Summit 2024
April 18-19, 2024 | Philadelphia, Pennsylvania
WuXi AppTec is proud to be exhibiting at Extractables & Leachables Summit April 18-19, 2024.
About the Extractables & Leachables Summit 2024
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. Among other agenda items, topics of discussion 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 and secondary packaging.
Kim Ehman, Ph.D., will speak on April 19 at 9:40 a.m. in a session titled “Approaches and Challenges with Chemical Characterization and Toxicological Risk Assessment for Absorbable Medical Devices.”
Speakers
- Dr. Kimberly Ehman, Director of Regulatory Toxicology & Consulting
- Molly Haan, Senior Technical Customer Support Scientist
Title: Approaches and Challenges with Chemical Characterization and Toxicological Risk Assessment for Absorbable Medical Devices
Abstract: Absorbable medical devices pose unique concerns for both chemical characterization and toxicological risk assessment (TRA). This presentation will provide a high-level overview of chemical characterization studies for absorbable medical devices, including exhaustive extractions, dissolution studies, and simulated-use approaches. The associated challenges will be addressed with specific case studies and proposed approaches for evaluation in the TRA. Additionally, chemical characterization and TRA may not always provide the full story for assessment of an absorbable device. Situations where additional data would be helpful (e.g., in vivo biocompatibility data) will also be discussed.
About the Extractables & Leachables Summit 2024? Meet With an Expert
Plan a visit to our booth or plan a virtual visit, and schedule time to speak with one of our subject matter experts in the area of medical device lab testing.