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 […]
Nitrosamine control: Real-world applications of ICH M7 Options 3 & 4 (Korean) Read More »
We were delighted to host the Lhasa Brazil Symposium: Aligning Pharma & Regulatory Standards Globally, which took place in São Paulo, Brazil. The one-day event on Monday, 14th July, brought together key representatives from the pharmaceutical industry and regulatory bodies, encouraging collaboration and aligning Brazil with global best practices. Throughout the day, attendees gained
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We were excited to attend the 65th Annual Meeting of the Society for Birth Defects Research and Prevention, which took place at the Hilton Denver City Centre in Denver, Colorado. The Society brings together experts from diverse scientific fields to better understand and protect against potential hazards to developing embryos, fetuses, children, and adults. The
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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
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We attended the 21st International Workshop on Quantitative Structure-Activity Relationships in Environmental and Health Sciences (QSAR2025), at the Mario Negri Institute in Milan. The event brought together leading researchers from academia, industry, regulatory bodies, and beyond to explore the latest developments, challenges, and future directions in the application of (Q)SARs for health and environmental safety.
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We attended the 13th International Conference on Chemical Structures at the Conference Centre in Noordwijkerhout, The Netherlands. The exciting four-day conference focused on the usage of Artificial Intelligence and Computer Aided Drug methods in Drug Discovery. By bringing together experts from cheminformatics, computational chemistry, and the pharmaceutical industry the event explored the latest innovations
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We were delighted to attend Extractables and Leachables US! Senior Global Alliances Manager Diego Gomes spoke at the event about our solution for mitigating Extractables and Leachables (E&L) risk, ‘Standardising Leachables Risk Management: A Collaborative Approach with Industry Experts’. To support consistent and informed decision-making, we present a Leachable Risk Management (LRM) tool designed to
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Where the world’s leading stability experts present the latest advances in stability science We were delighted to co-hosting the annual Science of Stability conference again with FreeThink Technologies as it returned for its 9th year! The conference was held at the Science History Institute in Philadelphia – May 19 – 21, 2025. The Science
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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
Nitrosamine control: Real-world applications of ICH M7 Options 3 & 4 Read More »
This year we are partnering with the Joint Pharmaceutical Analysis Group (JPAG) to bring you a fantastic one day event in London at the Royal Society of Chemistry. Stability VIII is essential for professionals managing drug stability, including respiratory products and unlicensed medicines. Expert speakers from academia, industry, and regulatory bodies will share insights on stability