Would users of the exchange and/or their networks find it useful if USP held a joint workshop or other with US FDA, EMA, and other Health Authorities to review the nitrosamine guidance documents in the subject region and develop risk assessment best practices for consistency within the pharmaceutical industry? Attendees could also
ask questions and receive answers to avoid misinterpretation of the guidance and align with the respective agency’s expectations as well as get any upcoming news on this topic. Please let me know if you would find this useful or suggest any topics!!! While my focus was originally on the risk assessments and requirements, I think other topics can be added as well.
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I would find this extremely useful. If not for myself at least for our regulatory person to support.
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It would certainly be helpful to clarify a few topics
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This would be definitely useful!
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This would certainly be very useful! Every effort to facilitate the communication between industry and regulators is welcome!
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This idea is very welcome, particularly because we’re discussing a subject that requires frequent updates involving different areas of knowledge.
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Any interaction with regulatory agencies on nitrosamine guidelines is always good to have, particularly due to the lack of consistency within the guidelines and between regional guidelines. From past experience, we will probably not get answers during such a workshop, but to surface the issues that concern industry is always good.
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