This event will bring together industry experts and researchers to explore key topics including impurity degradation, genotoxic impurity classification and evaluation, control strategies, and chemical safety decision-making. The symposium will share the latest scientific developments, practical experience, and regulatory insights to help attendees apply innovative technologies and best practices in impurity assessment and control.
Simultaneous translation between Korean and English will be provided.
Date: Tuesday, 25 November 2025
Location: Korea Institute of Science and Technology Center, Seoul, South Korea
Meeting highlights
The agenda is structured around four main themes:
1. Degradation, compatibility and strategies for impurity assessment
This session will focus on a crucial aspect of drug stability research – degradation and compatibility assessment.
Experts will introduce the Zeneth, demonstrating how it can identify potential degradation pathways, assess impurity risks, and optimise formulation strategies. Attendees will also learn how computational evaluation methods can support data-driven and scientifically sound decision-making in impurity management.
2. Classifying mutagenic impurities under ICH M7: Expert insights
This session will examine the evaluation and control of genotoxic impurities in alignment with the ICH M7 guideline. Through case studies, shared experience, and interactive discussion, experts will present the complete workflow – from in silico prediction to expert review. Topics will include practical control strategies, integration of computational and expert assessments, and approaches to ensure scientific rigour and regulatory compliance.
3. Comprehensive strategies for potentially mutagenic impurity (PMI) formation and control
Experts will explore the mechanisms and control of PMIs, focusing on clearance-based strategies to effectively manage N-nitrosamine impurities. This session will redefine the scientific framework for clearance evaluation across the pharmaceutical lifecycle and introduce the latest insights into NDSRIs (Nitrosamine Drug Substance Related Impurities).
4. Making confident chemical safety decisions with support from Lhasa
This session will demonstrate how Lhasa tools can be applied throughout the drug development process to enable confident, scientifically justified chemical safety decisions. Topics include nitrosamine risk assessment from discovery through to commercialisation, the use of read-across strategies, and how Consult Lhasa, a Lhasa Limited subsidiary, can support effective risk management and regulatory submissions.
Download the agenda in full here.
We warmly invite you to join this event to exchange ideas, share expertise, and advance impurity research in pharmaceutical development, register today using the button below.