In this free webinar, best practices for conducting extractables and leachables testing specific to drug-device combination products, ensuring safety and compliance. Attendees will gain insight into how to perform toxicological qualification of leachables using methodologies aligned with regulatory expectations, leveraging frameworks like ISO 10993-17 and ICH/PQRI. The featured speakers will discuss how to effectively integrate ISO 10993-12/-18 and USP 1663/1664 standards to develop a comprehensive and unified strategy for chemical assessment in combination products.
TORONTO, April 24, 2025 /PRNewswire-PRWeb/ -- Drug-device combination products offer patients and healthcare providers convenient access to safe and effective treatments.
However, integrating drugs and devices into a single product introduces unique challenges—particularly in ensuring patient safety through rigorous evaluation of extractables and leachables (E&L). One of the most complex aspects of E&L testing for combination products is aligning the often differing regulatory expectations from both drug and device health authorities.
This webinar will explore the contrasting standards for chemical characterization and toxicological qualification of E&L substances and propose a unified, dual-purpose strategy that satisfies both perspectives.
By integrating ISO 10993-12/-18 and USP 1663/1664 for chemical assessment, along with ISO 10993-17 and ICH/PQRI-based frameworks for toxicological qualification, attendees will gain practical guidance on developing a compliant and comprehensive E&L program for combination products. In this webinar, the expert speakers will focus on the following topics:
- Best practices for E&L testing in drug-device combination products
- Approaches to toxicological qualification of leachables using regulatory-aligned methodologies
- How to effectively apply both ISO 10993 and USP 1663/1664 standards in a unified E&L strategy
- Regulatory considerations for navigating drug and device requirements in combination product development
Register for this webinar today to gain insights into developing a compliant, dual-purpose extractables and leachables program for drug-device combination products.
Join Eric Hill, Chief Scientific Officer, Chemistry and Extractables & Leachables Labs, BA Sciences; and Dr. Isaac Mohar, Principal Scientist/Toxicologist Gradient, for the live webinar on Wednesday, May 14, 2025, at 1pm EDT (10am PDT).
For more information, or to register for this event, visit Qualification of Extractables and Leachables for Combination Products.
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