4th Extractables & Leachables

About 4th Extractables & Leachables

The characterisation of extractables and leachables (E&L) for drugs, biologics, medical devices and drug-device combination products to ensure product safety has matured in the last periods, and today we all are waiting in anticipation for the publication of the ICH Q3E guideline on E&L.

Since more new and complex pharmaceutical manufacturing and delivery systems are progressing towards development, a variety of ongoing practical considerations and insights around E&L are accumulated, the current E&L regulations are evolving, and new regulatory requirements are coming.

The analytical, toxicological, and regulatory experts in the E&L area will elaborate on ensuring the safety, quality, compatibility, and regulatory compliance for drugs, biologics, medical devices, and combination products.

Explore technical presentations and practical case studies, participate in Q&As and interactive panel discussions, and leverage win-win strategies, perspectives, and partnership opportunities at the 4th Extractables & Leachables (E&L) on May 10-11, 2023.

Presentations

Sandi Schaible, Senior Director of Analytical Chemistry & Toxicology, WuXi AppTec

Date: May 11th, 2023

Designing E/L studies with the Risk Assessment in Mind

Regardless of what type of extractable or leachable study is being conducted or what product is being tested (medical device, combination product, single-use system, container closure), one thing is consistent. The study should be designed with the risk assessment in mind.

• 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