Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges

Extractables and Leachables (E&L) are critical impurities that can migrate from pharmaceutical packaging into the drug product, potentially compromising patient safety. This webinar offers a foundational understanding of what E&L are, why they matter, how E&L can impact drug safety and stability, and how they are assessed in pharmaceutical manufacturing.

Participants will gain insights into the current, often fragmented, regulatory landscape and learn about evolving global guidelines that influence E&L evaluations. A special focus will be placed on the toxicological assessment of E&L, including their classification, integration into risk assessment strategies, and their role across the product lifecycle. The session will also explore the practicalities of designing and executing E&L studies, supported by real-world examples. 

Whether you're new to the topic or looking to deepen your expertise, this webinar provides the critical knowledge needed to navigate the complex regulatory and scientific terrain surrounding E&L.