In this Lhasa webinar we discussed alternative approaches to carcinogenicity assessment with Dr. Todd Bourcier (FDA) and Dr. Gina Hilton (PETA). Within many sectors of the life sciences industry, animal testing is still considered a primary option for toxicity testing, and as a result is used heavily. The limitations of this model are now well […]
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 »
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
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 »
We recently held our first webinar of 2023, ‘Supporting mutagenic impurity and degradant risk assessment using an in silico approach’. This free-to-attend webinar featured talks from Dr. Andreas Broehl, Laboratory Head at Bayer Pharmaceuticals, and Lhasa Limited Senior Scientist, Dr. Ash Ali. In this exciting virtual event, we explored how our in silico software solution Zeneth, can
Supporting mutagenic impurity and degradant risk assessment using an in silico approach Read More »
We were excited to attend USP’s Workshop on Nitrosamine Impurities, organised by United States Pharmacopeia (USP) in collaboration with Indian Pharmaceutical Alliance (IPA). Lhasa Principal Scientist, David Ponting presented within the Toxicity Assessment session, his presentation was titled ‘Application of in silico tools (QSAR) to predict toxicity’.
United States Pharmacopeia (USP) Workshop on Nitrosamine Impurities Read More »
We were thrilled to participate in the Extractables and Leachables Safety Information Exchange (ELSIE) Consortium webinar, titled ‘Framework for Sensitization Assessment of E&Ls and Practical Application’. Lhasa Principal Scientist, Martyn Chilton was a presenter and panellist at this event. Martyn’s talk detailed his work analysing the sensitisation potency of extractables and leachables in collaboration with
ELSIE Webinar: Framework for Sensitization Assessment of E&Ls and Practical Application Read More »
We were delighted to bring you a 2022 Global Zeneth Webinar series. Our Zeneth webinar series ran throughout June 2022 and consisted of a total of 7 Zeneth focused webinars held at different time, and in some cases, different languages, to accommodate different audiences around the world. The main topics discussed in this webinar were: – How Zeneth works, and how Zeneth is aligned with regulatory guidelines – Mechanistic understanding of degradation pathways – Use
We were delighted to bring you the webinar: An Introduction to Nitrite in Excipient Testing to Accelerate Route Cause Investigation of Nitrosamines. This exciting event included presentations from: Name:Dr. Joerg Schlingemann Title/Organisation:Merck Bio: Joerg Schlingemann is a Director and Principal Expert for Quality Control Systems within Merck KGaA’s / EMD Serono’s Healthcare Quality Unit. Joerg studied Molecular Biology in Uppsala and Heidelberg, where he completed a Doctorate degree
We were delighted to welcome Andrew Teasdale PhD and Muzaffar Khan PhD to present within our webinar; Controlling potentially mutagenic impurities – hear from industry experts! Andrew is currently the chair of AstraZeneca’s Impurity Advisory Board and has a wealth of knowledge developed over the last 20 years of working within the pharmaceutical industry. He is a leading AZ expert for a number of key impurity
Webinar | Controlling potentially mutagenic impurities – hear from industry experts! Read More »
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