We were delighted to attend the Extractables & Leachables Europe 2025 conference, held in Amsterdam, Netherlands.
The 25 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 actively contributed 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, Dr Jack Yung and Senior Global Alliance Manager, Diego Gomes, along with industry voices, Dr Lance Molnar, Head of Nonclinical Operations and Risk Assessment, Viatris and Patricia Parris, Toxicology Impurity Risk Management, Research Fellow at Pfizer, discussed the complexities of E&L risk assessment, particularly in light of the new ICH Q3E guideline.
They talked 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 was 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 explored:
- 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 analogues and building confidence in read-across
- Integrating read-across into PDE derivation for regulatory and risk-based decision-making
If you’re interested in learning more about in silico E&L management, please contact our team here.