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Please note this webinar was hosted in Japanese. 15:30 (JST) In this webinar we explored 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 […]

니트로사민 관리 전략 – ICH M7 옵션 3 및 4의 실제 적용 Please note this webinar will be in Korean, or dubbed in Korean with Korean subtitles only. 15:30 (KST) In this webinar from Lhasa Limited and BITEK, we explore the scientific and regulatory challenges of applying ICH M7 Control Options 3 and 4 to

Regulatory frameworks like ICH M7 have established in silico tools as a trusted method for evaluating the mutagenic potential of impurities, reducing reliance on animal testing and accelerating risk assessments. While these tools are widely accepted for mutagenicity, researchers and regulators are now looking at their potential for broader genotoxicity evaluations, including chromosome damage. As

In this webinar we explored 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 presented

Co-hosted with BITEK CHEMS on April 16th, this bilingual event was hosted in Korean, and include translated presentations from expert Lhasa and Consult Lhasa scientists. Experts David Ponting (Principal Scientist, Lhasa Limited) and Natan Segretti (CSO, Consult Lhasa) presented an explorative webinar on the recently updated EMA guidelines for nitrosoureas risk assessment.   Natan provided

This bilingual event was hosted in Japanese, and included translated presentations from expert Lhasa and Consult Lhasa scientists. Experts David Ponting (Principal Scientist, Lhasa Limited) and Natan Segretti (CSO, Consult Lhasa) presented an explorative webinar on the recently updated EMA guidelines for nitrosoureas risk assessment.   Natan provided a comprehensive overview of this critical regulatory

Experts David Ponting (Principal Scientist, Lhasa Limited) and Natan Segretti (CSO, Consult Lhasa), delivered an explorative webinar on the recently updated EMA guidelines for nitrosoureas risk assessment.   Natan provided a comprehensive overview of this critical regulatory update, explaining why nitrosoureas are classified within the cohort of concern and the reasoning behind these new regulatory

We were delighted to be on the programme at the 4th Annual Genotoxic Impurities Summit. Lhasa Principal Scientist Michael Burns presented ‘Reactivities of N-nitrosamines against Common Reagents and Reaction Conditions’. Impurities may have a negative effect on the efficacy, safety, and quality of pharmaceutical components and products. The successful development and manufacturing of novel medications now