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  • 1.  Multi-jurisdictional clinical trials

    Posted 14-Sep-2023 16:15

    Does anyone have experience filing investigational drug applications (INDs, CTAs, CTNs) in multiple jurisdictions simultaneously to perform a global clinical trial? If so, what are the procedural considerations, and are there any collaborative pathways between ICH regulators to streamline the review and approval of multijurisdictional trial applications?



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    Marshall Hoke
    Director of Regulatory Affairs
    Lafayette CO
    United States
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  • 2.  RE: Multi-jurisdictional clinical trials

    Posted 18-Sep-2023 06:27

    Hello Marshall,

    This is a very broad question. The short answer to it is - if you plan clinical trial in multiple countries you need to check the requirements in each country and submit separately. In EU you have 1 submission for multiple countries but you still need to consider the requirements in the different countries. Personally, I strongly recommend that you find local experts in the different countries who are familiar with the process. This way you will avoid a lot of confusions and delays of the study.

    Have a great 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


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