We are delighted to attend the Extractables & Leachables Europe 2025 conference, held in Amsterdam, Netherlands.
The E&L Europe conference is dedicated to discussing extractables and leachables examination as the importance of this area continues to grow. Given the release of the ICH Q3E draft guidelines, understanding the best practice and guidelines to carry out extractables and leachables studies is imperative in order to eliminate risk and potential development delays.
In line with this theme, Lhasa Limited will be actively contributing to the scientific programme with an expert-led workshop and speaker session:
E&Ls RISK ASSESSMENT UNDER ICH Q3E, ensuring quality method design and incorporating in silico approaches alongside existing safety data
Monday 3 November | 15:00 – 17:30
Scientist, Dr Julia Martins, Global Alliance Manager, Jack Yung and Senior Global Alliance Manager, Dr Diego Gomes, along with industry voices, will discuss the complexities of E&L risk assessment, particularly in light of the new ICH Q3E guideline.
They will talk through how to efficiently design target methods based on a complete understanding of leachable risk within drug formulation and how to then effectively link leachable studies to extractable results. Another key focus will be working through practical workflows and optimisation techniques, highlighting how advanced in silico tools can overcome common challenges in E&L safety assessments, leading to faster, more cost-effective, and defensible outcomes for both the pharmaceutical and medical device industries.
Performing confident read-across for E&L impurity safety assessments
Wednesday 5 November | 14:50 – 15:15
Dr Julia Martins will explore:
- Key considerations in conducting robust E&L safety assessments
- Addressing emerging toxicological challenges through structured approaches
- Leveraging in silico tools to strengthen read-across justification
- Strategies for selecting appropriate analogs and building confidence in read-across
- Integrating read-across into PDE derivation for regulatory and risk-based decision-making
We look forward to connecting with fellow scientists and sharing how Lhasa Limited collaborates with science-led solutions to shape the future of chemical safety assessments.
If you’re interested in learning more about in silico E&L management, please contact our team here.