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Nitrosoureas and beyond: What to do when the CPCA doesn’t apply – Japan

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 […]

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Nitrosoureas and beyond: What to do when the CPCA doesn’t apply

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

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4th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2024

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

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Classification of Potentially Mutagenic Impurities under the ICH M7 Guideline (in Japanese)

This webinar is specially prepared for the Japanese-speaking scientific community. Presentations will be delivered in English, with Japanese subtitles provided. It is designed for scientists, researchers, and regulatory professionals who want to strengthen their understanding of the ICH M7 guideline and its impact on the classification of mutagenic impurities. By attending, you will: Gain up-to-date

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Ensuring API safety: Strategies for impurity and degradant management under ICH M7

Managing impurities in Active Pharmaceutical Ingredients (APIs) while meeting ICH M7 can be challenging. The need to quickly identify potential impurities, assess their toxicological risk and ensure compliance with mutagenicity and carcinogenicity guidelines demands a streamlined, reliable process. Held in Spanish, this webinar showcased how in silico tools Zeneth, Derek Nexus, and Sarah Nexus can

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How to develop impurity control strategies without analytical testing

10 am (EST) / 3 pm (GMT) / 4pm (CET) This webinar detailed how to develop control strategies in line with ICH M7 guidelines without expensive and time-consuming analytical testing. We showed how you can assess carryover risk for potentially mutagenic impurities (including nitrosamines) in your drug development workflow. We were delighted to have Senior

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Prediction of degradation products: In silico tools for analytical development (in Spanish)

Predicción de productos de degradación: Herramientas in silico para el desarrollo analítico We are delighted to be hosting this upcoming Spanish-language webinar tailored toward analytical chemists based in Latin America. We introduce the concept of theoretical degradation prediction and run through some case studies relating to: – Structural elucidations of unknowns – Rationalising the formation

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Your forced degradation problem-solving session (Portuguese)

Please note this session will be in Portuguese only.  We are looking forward to holding our upcoming webinar all about supporting forced degradation studies with in silico tools as part of your workflow. With Scientist Meire Kawamura and Senior Global Alliances Manager Diego Gomes, this session will cover four case studies demonstrating how in silico

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ICH S1B(R1) industry and regulatory best practice for confident carcinogenicity assessment

The ICH S1B(R1) addendum is a globally recognised guideline that introduces a weight-of-evidence (WoE) approach to assessing the carcinogenic potential of pharmaceuticals.  It helps pharmaceutical organisations determine whether a two-year rat carcinogenicity study would provide additional insight into human safety. In this session, you will hear directly from former regulatory and industry experts who contributed

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Analytical challenges and the effective management of nitrosamines: The evolving landscape of NDSRI analysis

We were delighted to take part in an online seminar and panel discussion with ThermoFisher Scientific on 29th October. Nitrosamine Drug Substance related impurities (NDSRIs) remain a topic of significant concern to the pharmaceutical industry with multiple batch recalls in 2022+ across different drug classes including beta blockers and ACE inhibitors to name but a

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