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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

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

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

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

Watch our Lhasa webinar to deepen your understanding of the ICH M7 guidelines and their application in classifying mutagenic impurities.   Learn from regulatory and industry leaders through expert presentations and real-world case studies. The webinar agenda includes: Introduction to ICH M7 guidelines Dr Roland Froetschl, from the Federal Institute for Drugs and Medical Devices,

We co-hosted this exciting webinar with BITEK CHEMS on July 17th! The bilingual event was hosted in Korean and included presentations in English from expert Lhasa scientists. BITEK CHEMS are a trusted distributor of Lhasa Limited solutions in South Korea. We were thrilled to be co-hosting this event with BITEK, 14:00 – 15:00 (KST). Featured