Catch up on the latest Lhasa webinars
Featured webinars:
Nitrosamine control: Real-world applications of ICH M7 Options 3 & 4
Learn from industry leaders through expert presentations and real-world case studies.
- 15 May 2025
Catch up on our webinar where 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 evidence-based strategies to justify process-driven control strategies (Option 4) and hybrid approaches (Option 3) for these high-potency impurities.
- Authors Mike Urquhart (GSK), Marzia Galli (Merck) and Paula Tomlin (AstraZeneca) each presented on a real-world case study showing how purge calculations could be leveraged for nitrosamine impurity control.
- Jack Yung (Lhasa Limited) demonstrated the value of using in silico tool Mirabilis to carry out nitrosamine risk assessment.
- There was a live Q&A following the presentations where attendees had the opportunity to ask any questions to the speakers.
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.
- 26 March 2025
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 changes.
Following this, David delivered a practical demonstration of our in silico read-across tool, Acrostic. Through a detailed nitrosourea case study, attendees witnessed first hand how the software can be effectively utilised to determine acceptable intake limits for nitrosoureas in accordance with the latest EMA requirements.
Webinar learning objectives:
- A comprehensive understanding of the updated EMA guidelines on nitrosoureas and why these compounds require regulatory attention.
- Practical insights into applying in silico read-across methodology for nitrosoureas evaluation using Acrostic.
- Effective strategies for establishing evidence-based acceptable intake limits that align with regulatory expectations while supporting your scientific goal.
How to develop impurity control strategies without analytical testing
Learn from regulatory and industry leaders through expert presentations and real-world case studies.
- 26 November 2024
Catch up on our webinar on how to develop control strategies for potentially mutagenic impurities in line with ICH M7 guidelines, without expensive and time-consuming analytical testing. We show you how you can assess carryover risk for potentially mutagenic impurities in your drug development workflow. The webinar includes the talks by two presenters as follows:
Dr Andy Teasdale, Senior Principal Scientist at AstraZeneca
Andy described the concept of purge factors and purge scoring for controlling potentially mutagenic impurities outside of the lab.
Dr Emma Pye, Scientist at Lhasa Limited
Emma introduced Mirabilis and discussed how they can be combined to provide an overall ICH M7 classification. Robert demonstrated how Nexus can support expert review which is important for all predictions used in a regulatory submission.
Classification of potentially mutagenic impurities under the ICH M7 guideline
Learn from regulatory and industry leaders through expert presentations and real-world case studies.
- 5 September 2024
Watch our webinar to deepen your understanding of the ICH M7 guidelines, and their application in classifying mutagenic impurities. Topics our speakers covered included:
Dr Roland Froetschl, Federal Institute for Drugs and Medical Devices
Roland opened the webinar by introducing the ICH M7 guidelines and explained how expert-based and statistical systems can be used together to classify mutagenic impurities. Roland also discussed the benefits of using in silico methods for assessing new drug candidates.
Dr Robert Foster, Principal Scientist at Lhasa Limited
Robert introduced Derek Nexus and Sarah Nexus and discussed how they can be combined to provide an overall ICH M7 classification. Robert demonstrated how Nexus can support expert review which is important for all predictions used in a regulatory submission.
Dr Alyssa Musso, Global Risk Assessment Services Toxicologist within Drug Safety Research and Development at Pfizer
Alyssa demonstrated a detailed case study showcasing how Pfizer implements Derek Nexus and Sarah Nexus for ICH M7 submissions.
Read-across masterclass webinar
How to facilitate your acceptable intake limit setting for nitrosamines.
- 25 April 2024
Read-across is a popular data gap filling technique which has recently gained recognition in regulatory guidance as a valuable tool for identifying suitable surrogates in establishing Acceptable Intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).
We held an informative webinar where we unveiled Acrostic, our novel read-across solution designed to facilitate decision-making when determining AI limits for nitrosamine compounds. Attendees learnt about how Acrostic utilises a standardised, reliable and transparent framework through worked NDSRI examples.
Dr David Ponting, Principal Scientist at Lhasa Limited
David discussed the Carcinogenic Potency Categorisation Approach (CPCA) for N-nitrosamine impurity assignment and demonstrated how Acrostic complements the CPCA in calculating appropriate AI limits.
Dr Charlie Modlin, Senior Application Scientist at Lhasa Limited
Dr Modlin introduced Acrostic, our innovative in silico read-across tool, and showcased its purposeful workflow through examples, offering insights into how Acrostic evaluates nitrosamine carcinogenicity.
Identifying the formation of nitrosamines via degradation pathways using an in silico approach
Identification and mitigation of potentially mutagenic impurities in APIs.
- 25 April 2024
Ensuring the safety of active pharmaceutical ingredients (APIs) is of great importance. A critical aspect of this process involves the identification and mitigation of potentially mutagenic impurities, like nitrosamines. Our in silico tool Zeneth has been used within exploratory formulation departments to understand and account for potential degradation problems within the API at an early stage, resulting in advanced understanding of possible degradants.
This event featured presentations followed by a Q&A session facilitated by Principal Scientist, Dr Rachel Hemingway – lead scientist for Zeneth.
Dr Lawrence Tam, Scientist at Lhasa Limited
Dr Tam demonstrated how to use Zeneth to detect degradation problems early in the drug development workflow.
Dr Manoj Kumar Singh and Rimita Chakraborty, MicroLabs
Manoj and Rimita present a case study on how to use Zeneth to support nitrosamine risk assessment.
How to predict for the formation of NDSRIs
- 29 November 2023
Nitrosamine Drug Substance-Related Impurities (NDSRIs) have become a major concern in the pharmaceutical industry due to their potential to pose serious health risks to patients. Understanding how to predict and manage the formation of NDSRIs is vital to ensure the highest quality and safety standards are met in drug development and manufacturing processes.
In this webinar, we assembled a distinguished panel of experts who specialize in the fields of pharmaceutical process chemistry and quality control. Their vast knowledge and experience guided us through the complexities of predicting the formation of NDSRIs and the practical approaches to mitigate these risks effectively.
Dr Leonardo Allain, Scientist at Merck
Dr Allain discussed excipient nitrite risk assessment, mitigation strategies Merck have considered and how using data can support a nitrosamine assessment.
Dr Giorgio Blom, Senior Trace Analysis Lead at AstraZeneca
Dr Blom presented on Nitrite test methods, their associated challenges and ongoing comparative testing.
Dr James McManus, Senior Scientist at Lhasa Limited
Dr McManus presented on Lhasa’s most recent work surrounding nitrosamine impurities, including nitrosamine formation risk technology within Mirabilis and nitrosating pathway prediction in Zeneth.
Interested in being a part of a Lhasa webinar?
If you’re interested in presenting within a Lhasa webinar, reach out to a member of our marketing team for more information.