3-year work plan for EMA Nitrosamine Safety Operational Expert Group

As I examined the recently published EMA 3-year Work plan for the non-clinical domain, I wanted to share a few of the Nitrosamine related highlights plan for 2023

  • Facilitate access and knowledge to in silico/QSAR applications for assessment of mutagenic
    impurities (e.g. nitrosamines). There is a need to harmonize approaches in this area in the EU
    with proper training of non-clinical assessors. [short-term]

  • Continuous support of Committees and active participation in international fora related to
    genotoxic impurities (including nitrosamines). [long-term]

  • Organise 1-2 meetings with interested parties on nitrosamines [Stakeholder activities - European level]

  • Co-operation with international regulators on nitrosamines [Communication activities - International level]

Link: https://www.ema.europa.eu/en/documents/other/non-clinical-working-party-ncwp-work-plan-2022-2024_en.pdf

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