Regulatory Open Forum

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  • 1.  What topics would you like to see on RegEx more often?

    Posted 4 days ago

    Folks, I know we’re very medical device-heavy on this forum. What other topics would you like to see us talking about here on the Regulatory Open Forum? Let me know and I’ll work on it!



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    Ryan Connors
    Social Media and Communications Specialist
    RAPS
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  • 2.  RE: What topics would you like to see on RegEx more often?

    Posted 3 days ago
    I'm interested in seeing more topics around biologics.  From biologic drug development to safety reporting to ODD request strategies (use of animal models in supporting information) in the US as well as globally.

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    Kelly Patrick, RAC
    Regulatory Affairs Project Manager
    Exeter, NH
    USA
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  • 3.  RE: What topics would you like to see on RegEx more often?

    This message was posted by a user wishing to remain anonymous
    Posted 3 days ago
    This message was posted by a user wishing to remain anonymous

    I would like to see more discussions on detailed nuances for best practices to manage documents in the eCTD. For example, when a CMC change is being proposed that requires Prior Approval, in which section(s) does one place the proposed revised eCTD section documents or supporting documents? Then when the proposed change is approved, when do the proposed documents replace the current documents in Module 3? Or, under what circumstances would a 3.2.P.2 Pharmaceutical Development section document be updated?


  • 4.  RE: What topics would you like to see on RegEx more often?

    This message was posted by a user wishing to remain anonymous
    Posted 2 days ago
    This message was posted by a user wishing to remain anonymous

    I agree, this would be helpful.


  • 5.  RE: What topics would you like to see on RegEx more often?

    Posted 2 days ago
    As you said, Ryan, it's a good place for medical device questions because there are lots of active medical device folks here because it's a good place for medical device questions...

    Speculating, maybe medical device companies are more likely to have tiny regulatory groups (or just individuals), where pharma companies may tend to have regulatory groups large enough to provide some peer support.

    Of course some aspects of devices are more thoroughly covered than others. Some parts of the pharma space are pretty well covered. Veterinary, cosmetic, food, and cannabis questions are more rare, though they generally find answers, too. Some countries are better covered than others. Related disciplines and regulations sometimes appear - biology, engineering, quality, privacy, import/export, and so on... The diversity is fun.

    A question for you. How many early-career and later-career RAPS members do we have working in each definable area? And what fraction from each subset are reasonably active in the forum?

    If there are smaller groups inactive because they don't see themselves here, but they're large enough for a potential critical mass of shared discussion areas, maybe invite them in all at once with some seed topics and see if it turns out to work for them.

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    Anne LeBlanc
    United States
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