Chat with us, powered by LiveChat

Past

FDA and the Center for Research on Complex Generics (CRCG) workshop

We were thrilled to  attend this workshop to discuss: ‘Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products’. This event featured vital discussions around risks of forming NDSRIs in certain drug products, strategies to mitigate these risks, and considerations in assessing the safety risks of NDSRI. Lhasa Limited Principal […]

FDA and the Center for Research on Complex Generics (CRCG) workshop Read More »

FDA/HESI Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs workshop

We were pleased to attend the FDA/HESI Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs workshop. Organised by the FDA and HESI, this exciting event offered attendees the opportunity to engage in important discussions around the assessment of nitrosamines, including Nitrosamine Drug Substance-related Impurities (NDSRI). Lhasa Principal Scientist, David Ponting presented

FDA/HESI Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs workshop Read More »

Nonclinical Carcinogenicity Studies: Fundamentals, Case Studies and Regulatory Trends

Dr. Susanne Stalford, Lhasa Principal Scientist, presented within a Pharmaceutical & BioScience Society workshop, on the topic of Nonclinical Carcinogenicity Studies. The workshop included presentations from regulatory and industry perspectives, on topics relating to carcinogenicity assessment of pharmaceuticals, including: The challenges faced with carcinogenicity assessments, in the development of pharmaceuticals Regulatory and industry perspectives on

Nonclinical Carcinogenicity Studies: Fundamentals, Case Studies and Regulatory Trends Read More »

Extractables & Leachables USA

We thoroughly enjoyed attending Extractables and Leachables USA! This event offered a unique opportunity for E&L industry experts to gather and discuss the latest updates on regulations, best practices, compliance, case studies, biocompatibility, and more. Lhasa Application Scientist, Charlie Modlin presented “Using expert knowledge and machine learning to assess the mutagenicity and skin sensitisation potential

Extractables & Leachables USA Read More »

Pharmaceutical Industry and Regulators Symposium

We were delighted to return to Brasilia to host the Pharmaceutical Industry and Regulators Symposium! Held at the the Auditório do Conselho Federal de Farmácia, this two-day event featured insightful presentations from speakers from both industry and regulators. The Symposium brought together like-minded researchers and regulators, offering attendees a unique opportunity to gain a greater

Pharmaceutical Industry and Regulators Symposium Read More »

Society of Toxicology (SOT) 62nd Annual Meeting and ToxExpo

Held in Nashville, Tennessee, the SOT 62nd Annual Meeting and ToxExpo featured an array of scientific sessions, posters and presentations. A team of us from Lhasa attended the event, where we hosted two exhibitor-hosted sessions: Tackling ICH S1B using AOPs Supporting drug development using in silico solutions Lhasa Limited scientific posters, in date order. Poster Title: Mechanisms

Society of Toxicology (SOT) 62nd Annual Meeting and ToxExpo Read More »

7th Impurities: Genotoxic, Nitrosamine & Beyond Summit

We were delighted to attend the 7th Impurities: Genotoxic, Nitrosamine & Beyond summit in Milan, Italy. In addition to focusing on N-nitrosamines, this event explored detecting and reporting genotoxic impurities, as well as recent advances, further development and future considerations towards the different types of impurities present in drugs. Lhasa Principal Scientist, Michael Burns presented

7th Impurities: Genotoxic, Nitrosamine & Beyond Summit Read More »