Please note this webinar will be in Japanese and dubbed in Japanese with Japanese subtitles only.
15:30 (JST)
In this webinar we explore the scientific and regulatory challenges of applying ICH M7 Control Options 3 and 4 to manage nitrosamine impurities in pharmaceuticals. Drawing on real-world case studies from the recently published journal article Industrial Case Studies Demonstrating Applicability of ICH M7 Control Options 3 and 4 for Nitrosamine Control, the authors present evidence-based strategies to justify process-driven control strategies (Option 4) and hybrid approaches (Option 3) for these high-potency impurities. Attendees will gain insights into balancing regulatory expectations, scientific rationale, and practical implementation.
- Author and Lhasa Principal Scientist Michael Burns introduces the research.
- Authors Mike Urquhart (GSK), Marzia Galli (Merck) and Paula Tomlin (AstraZeneca) each present on a real-world case study showing how purge calculations could be leveraged for nitrosamine impurity control.
- Jack Yung (Lhasa Limited) demonstrated the value of using in silico tool Mirabilis to carry out nitrosamine risk assessment.
- There will be a live Q&A following the presentations where attendees had the opportunity to ask any questions to our team in Japan, Satoshi Mashiko and Yu Jin.