Webinar - ICH Q3E: Opportunities for Early Adoption and Challenges

As the first dedicated ICH guideline focused on extractables and leachables, Q3E is expected to shape future regulatory expectations and harmonise approaches across global markets. In this first webinar of Intertek's Extractables & Leachables Readiness Series, our expert will examine the draft guideline, comparing its requirements and recommendations with existing industry guidance and standards.

ICH Q3E, as indicated in the guidance document, aims to provide “a holistic framework and process for the assessment and control of leachable impurities.” The guidance goes beyond current regulatory guidance in providing expanded thresholds based on route of administration and duration of treatment. The guidance also expands upon the classification of leachables and provides limits applicable for leachables from the different classes. Opportunities exist to leverage the approaches presented within the guidance. However, as with most new guidance, additional detail may result in expanded analytical workflows. This webinar, presented by Louis Fleck, Laboratory Manager, Trace Organic Analysis Group, will review the content of the guidance and will discuss opportunities for early adoption, including examples where the expanded thresholds may provide opportunities for simplified study implementation.  

Key learning points:

• Understand the scope, objectives and key provisions of draft ICH Q3E
• Compare Q3E with existing global E&L guidance and standards.
• Identify opportunities for early adoption and implementation.
• Explore implications for study design.
• Highlight opportunities for simplified study implementation.

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