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.

Presentations

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