Neotron, together with a guest speaker from Innovatune, is pleased to invite you to a webinar taking place on 25 June 2025 at 11:00 A.M. CEST.
As the demand for safety and regulatory compliance intensifies across the pharmaceutical, biopharmaceutical, and medical device industries, a robust understanding of Extractables and Leachables (E&L) has become essential.
Join us for this comprehensive webinar, hosted by Neotron and featuring a guest speaker from Innovatune, as they provide critical insights into the science of E&L, regulatory expectations, and practical strategies for effective testing and risk assessment. The session will cover the basics of extractables and leachables (E&L), explore the regulatory landscape, and provide an overview of current E&L requirements.
Key Takeaways:
Clarity on Core Concepts: Understanding of what extractables and leachable are, and why they are critical to product safety and regulatory compliance.
Regulatory Readiness: Learn about the current regulatory expectations for E&L across pharmaceuticals, biopharmaceuticals, and medical devices, including key standards (e.g., ISO 10993, USP <1663>/<1664>/<1665>) and how to proactively meet them.
Integrated Risk Assessment: Learn how E&L data supports toxicological risk assessment, material selection, and overall product safety evaluations.
Strategic Testing Approaches: Discover how to design efficient, scientifically sound E&L studies, including approaches for single-product testing and leveraging data across multiple products through smart testing strategies.
Analytical Methodologies: Understand the various analytical techniques used in E&L testing.
ICH Q3E and toxicological risk assessment frameworks: What’s between data-rich and data-poor substances, guiding the use of experimental data or predictive tools like (Q)SAR and read-across to assess E&L safety.
Permitted Daily Exposure (PDE) values: Centrality of risk assessment, derived from high-quality toxicological data or supported by alternative methods when data are limited, ensuring a scientifically sound and patient-protective approach.
Attendees will learn how to design project strategies aligned with global standards through testing, validation, and risk-based approaches. A detailed section on analytical techniques will focus on key methodologies for E&L detection, emphasizing smart testing strategies.
We look forward to your participation in this valuable session!
To secure your spot, click here to register.