Where do you obtain your latest regulatory information for continuous manufacturing adoption, innovation, and implementation?

Hello Regulatory Science Community,

Where do you obtain your latest regulatory information for continuous manufacturing adoption, innovation, and implementation? Share your key and reliable sources of information:

  • Official Regulatory Websites:
    • Do you have go-to website resources that allow you to stay updated?
    • Do they provide comprehensive guidelines, standards, etc critical for successful continuous manufacturing adoption?
    • What about international regulatory landscape and resources?
  • Journals and Papers:
    • Do you have any recommendations on academic journals that offer studies, analysis for continuous manufacturing regulatory landscape development?
    • Any international sources that offer articles on the global regulatory landscape in the continuous manufacturing field?
  • Databases and Search Engines:
    • Do you have go-to search tools?
    • What about AI capabilities?
  • Industry Conferences, Workshops, and Meeting:
    • Any conferences, meetings, etc offer first-hand insights into regulatory changes, and discuss continuous manufacturing processes and practices, regulatory issues and strategies?
  • Professional Organizations:
    • Any professional organizations, groups or associations that give you access to the latest regulatory information domestically and internationally?

Do you leverage other resources that you can share?

Parents Reply
  • Katie, thank you for sharing the article above. Discussion regarding the process modeling vs testing certainly captured my attention. 

    "The US pharmaceutical industry has told the US Food and Drug Administration (FDA) that using process models alone is sufficient for assessing batch uniformity in advanced manufacturing. They believe that it is not necessary to combine this approach with in-process material testing to demonstrate uniformity."

    Will be curious to hear from others their thoughts on this insightful point - can we rely on the process modeling alone? I am certain this is probably a fundamental regulatory consideration and question – how much do we trust predictive testing vs actual testing?

    Do not hesitate to share your thoughts and experiences!

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