Join pharmaceutical scientists, toxicologists, regulatory professionals and industry experts at the Lhasa South Korea Symposium 2026 in collaboration with BITEK CHEMS, for a day dedicated to practical solutions for today’s most pressing safety and regulatory challenges.
Through a combination of scientific presentations, regulatory perspectives and real-world industry case studies, attendees will explore effective approaches to impurity assessment, formulation development, nitrosamine management, extractables and leachables risk assessment, and mutagenic impurity control. The programme will highlight how in silico science is helping organisations make more informed decisions, respond to evolving regulatory expectations and strengthen submission strategies.
Designed for professionals working across pharmaceutical development, regulatory affairs, toxicology, quality and risk assessment, the symposium offers valuable insight into how scientific innovation can support more efficient development programmes and greater confidence in regulatory decision-making.
Event Details
Date: Tuesday 20th October 2026
Location: Seoul, South Korea
Symposium Agenda
Integrated strategies for impurity assessment and confident chemical safety decisions
Modern impurity assessment requires a connected approach that brings together predictive science, expert knowledge and regulatory understanding. This opening session explores how integrated in silico workflows can support impurity identification, safety assessment and regulatory decision-making throughout pharmaceutical development. Using practical examples from the generics industry, attendees will learn how scientific teams can streamline workflows, strengthen justifications and make more confident decisions when evaluating complex impurity challenges.
Practical safety strategies for nitrosamines and potentially mutagenic impurities
Regulatory expectations for nitrosamine assessment continue to evolve globally. This session examines practical approaches to assessing potentially mutagenic impurities, responding to regulatory questions and establishing scientifically justified nitrosamine limits. Through real-world case studies, attendees will learn how organisations can navigate uncertainty, adapt to changing guidance and build stronger, science-based safety assessments.
From formulation to nitrosamine risk assessment: Managing degradation & impurity challenges
Discover how in silico approaches are transforming formulation development and degradation risk assessment. Through practical examples and industry case studies, this session will explore how scientists can identify potential degradation pathways, assess nitrosamine impurity risks and support formulation decision-making earlier in development. Attendees will also gain insights into current regulatory perspectives and emerging considerations around nitrosamine formation.
Applying read-across to support modern extractables & leachables risk assessments
As extractables and leachables assessments become increasingly important, understanding both regulatory expectations and scientific justification is critical. This session will examine current approaches to E&L risk assessment and provide practical insight into how experts apply read-across methodologies to support regulatory decision-making with greater confidence.
From deficiency letters to effective control strategies: Managing mutagenic impurities in practice
Successfully controlling mutagenic impurities requires more than regulatory knowledge alone. This session focuses on real-world approaches to impurity control, including lessons learned from regulatory feedback, deficiency letter responses and practical implementation of purge-based strategies. Through industry case studies and nitrosamine-focused examples, attendees will gain a clearer understanding of how scientific justification and in silico approaches can be combined to support robust regulatory submissions and effective impurity control programmes.