E&L West (PharmaEd)
Extractables & Leachables – West
November 2-3, 2023 | La Jolla, California
WuXi AppTec is proud to be exhibiting at the Extractables and Leachables – West on November 2-3, 2023.
About Extractables & Leachables – West
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.
Sandi Schaible, Senior Director of Analytical Chemistry & Toxicology, WuXi AppTec
Date: April 18th, 2023
Biological Risk Assessment in E&L Study Design
Regulatory bodies are looking for objective evidence of safety. Designing your studies should take into account the biological risk assessment process (ISO 10993-1). This presentation will cover several key topics in this field, including:
- Importance of the Risk Assessment and overview of the process
- Key inputs for the Risk Assessment and how they relate to the E/L study
- Essential components of an E/L Study