Navigating Evolving Regulations and Toxicological Challenges
This webinar offers a foundational understanding of Extractables and Leachables (E&L), highlighting their impact on drug safety and stability, and current regulatory frameworks. It covers toxicological assessments and best practices in study design, supported by real-world examples to navigate the complex landscape surrounding E&L.
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.
向最优秀的人学习
Meet our expert speakers who will share valuable insights and practical knowledge drawn from extensive industry experience.
Global Toxicology Liason
Natalia holds a PharmD and a Master's degree in Drug Research, Development and Innovation. With a strong background in business development, her career also...
Consultant Toxicology
Javier holds a degree in Chemistry and a Master’s in Drug Discovery. He began his career in public research, focusing on the synthesis and structural characterization of cannabinoids, gaining valuable experience in organic chemistry and analytical techniques, moving later to the pharmaceutical industry focusing method validation and risk assessment of extractables and leachables (E&L) and elemental impurities in accordance with ICH Q3D guidelines.
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QbD Group offers a set of Toxicology services, for your processes, applications, and equipment. We are EUROTOX certified and are members of AETOX.
