Wednesday 12 November – 15:00-16:00 CET / 14:00-15:00 GMT / 9:00-10:00 ET
The potential presence of nitrosamines in drug products continues to be a global concern and remains a focus of regulatory agencies worldwide.
IPEC Federation revised its Nitrosamine Questionnaire to ensure alignment with the latest scientific and regulatory developments and to support communication across the pharmaceutical supply chain.
This webinar will provide an overview of the updated version of the Questionnaire, explaining how it assists both excipient manufacturers and marketing authorization holders (MAHs) in gathering and sharing relevant data to support drug product nitrosamine risk assessments, and enabling MAHs to fulfil their regulatory responsibilities.
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