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  • 1.  Use of Investigational Device in Clinical Trial in EU Phase 1

    Posted 19-May-2023 11:03
    Edited by Ed Panek 19-May-2023 11:16

    Without knowing the country, how long would the ask for approval take from an in-country competent authority? Is there an expert available reading this for private messaging questions and assistance?



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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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  • 2.  RE: Use of Investigational Device in Clinical Trial in EU Phase 1

    Posted 22-May-2023 04:40

    Hello Ed,

    It depends which country you need. I can tell you about the UK as I am involved in setting up clinical trials there. MHRA approval process takes about 3 months and about 2 months to REC approval. You can submit in parallel. How long it will take depends on how organised you are to address validation questions and pre-clinical review questions. Some clients take a long time to respond to these and in that case the approval takes longer.

    Have a good week.
    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
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    Original Message


  • 3.  RE: Use of Investigational Device in Clinical Trial in EU Phase 1

    Posted 23-May-2023 02:12

    That depends on a bunch of factors, so impossible to say in abstract. As Olga observed, quality of documentation and level of organisation on client side can make a huge difference. In my own country (the Netherlands) a pre-discussion with the METC involved to help clear any issues before the sponsor submits helps a lot to keep things moving at speed.



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


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