Nitrosamines are emerging as a significant concern in the pharmaceutical industry, posing regulatory and safety challenges for manufacturers. Are you prepared to address these risks effectively?
Our panel of expert speakers discussed why nitrosamines have become a growing concern and the latest regulatory developments in Argentina and Mexico. This webinar also introduced innovative in silico solutions designed to streamline and enhance nitrosamine risk assessment, ensuring compliance and safety.
- 4th February
- 12:00 – 14:00, Argentinian time
- Spanish
1. Why are nitrosamines a risk?
Presented by: Maria Celeste del Fueyo, Lhasa Limited
- What are nitrosamines and why are they a growing concern in pharmaceuticals?
- Examine the impact on industry and the urgency for effective solutions.
2. Status of nitrosamine regulation in Argentina
Presenter: Pablo Quiroga, Faculty of Exact Sciences – National University of La Plata
- Nitrosamine impurities: Mechanisms of genetic toxicity and in vitro and in vivo assays for mutagenicity.
- Approaches and criteria for determining acceptable intake of Nitrosamine Drug Substance-Related Impurities (NDSRI).
- Standards and requirements that must be met by analytical methods used in the detection and evaluation of impurities.
3. Regulatory Overview: Mexico’s Perspective
Presenter: Mariah Ultramari, Consult Lhasa
- Overview of regulatory requirements and guidance for nitrosamines in Mexico.
- What this means for pharmaceutical companies operating in the region.
- Explore how Consult Lhasa’s services can help businesses meet these challenges.
4. Solutions to the nitrosamine problem: in silico tools for risk assessment
Presenter: Lucia Toscano, Lhasa Limited
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- Lhasa Limited’s approach to nitrosamine risk assessment.
- Step-by-step tour of the Lhasa in silico workflow, featuring Derek Nexus, Sarah Nexus, Zeneth, Mirabilis and Vitic Nitrites Data Sharing Consortium.
5. Live Q&A Session
- Engage directly with our speakers and get answers to your questions.
Why attend?
- Gain insights into nitrosamine risks and their regulatory implications in Mexico and Latin America.
- Learn how innovative in silico tools can enhance your risk assessment processes.
- Discover practical applications through real-world examples.