Join us for our upcoming webinar, ‘How to establish acceptable intake limits for NDSRIs’. This webinar will be hosted in Japanese and will contain pre-recorded videos with Japanese subtitles. This virtual event will begin at 15.00 (JST) and last approximately 2 hours.
Nitrosamine Drug Substance-Related Impurities (NDSRIs) have emerged as a significant cause for concern within the pharmaceutical industry due to their potential to pose serious health risks to patients. In order to facilitate nitrosamine safety assessments, regulatory bodies such as the US FDA, EMA, and Health Canada have issued guidelines outlining recommended AI limits for NDSRIs. In this webinar, we will explore nitrosamine safety assessment and discuss strategies to facilitate regulatory compliance within the pharmaceutical industry for NDSRIs.
Dr Martin Walter, Assessor at the Austrian Medicines and Medical Devices Agency will present on nitrosamine safety assessment and the most recent updates issued by the EMA surrounding the Enhanced Ames Test (EAT) and Carcinogenic Potency Categorisation Approach (CPCA).
Dr Raphael Nudelman, Senior Director Impurity Expert from Teva will discuss the bacterial reverse mutation (Ames) test in relation to nitrosamines, using read-across assessment to determine a suitable surrogates for higher AI intake limits and the complex nitrosamines data sharing initiative.
Dr David Ponting, Principal Scientist at Lhasa Limited will present on Lhasa’s recent work surrounding read-across and nitrosamine related Lhasa data sharing initiatives.
Finally, Satoshi Mashiko, Business Partnerships Manager will give a live demonstration of Acrostic, Lhasa’s new in silico read-across solution.