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

This webinar on demand aims to provide a comprehensive overview of Extractables and Leachables (E&L) in pharmaceutical products, highlighting regulatory complexities, toxicological challenges, and practical approaches to study design and risk assessment across the product lifecycle.

Let's decode E&L risks and safeguard product safety and regulatory compliance!

On demand

Pharma

English

About the webinar on demand

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.

webinar - riesgo de las nitrosaminas - QbD Group

What you'll learn

The fundamentals of Extractables and Leachables (E&L), including definitions, sources, and their impact on drug safety.
Current regulatory framework, including gaps, challenges, and relevant global guidelines.
Insight on toxicological risk assessment strategies for E&L throughout the pharmaceutical product lifecycle.
Best practices for designing and executing E&L studies, from planning to reporting.
Review real-world study examples to understand practical applications and common pitfalls in E&L evaluations.

Speakers

Meet our expert speakers who will share valuable insights and practical knowledge drawn from extensive industry experience.

Natalia Herrera

Global Toxicology Liason

Natalia holds a PhD in Pharmacy from the University of Medical Sciences of Costa Rica and a Master's degree in Drug Research, Development and Innovation from the University of Navarra. With a strong background in business development, Natalia previously worked in a preclinical CRO, where she excelled in driving growth and establishing strategic alliances. Her career also includes outstanding contributions as Medical Sales Representative in different companies, such as Abbott. In addition, Natalia has valuable experience in quality assurance from her time at Pfizer and other pharmaceutical manufacturing sites, ensuring compliance with industry standards.

Javier López

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.