Regulatory Open Forum

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  • 1.  Ukraine and Ongoing Clinical Trials

    Posted 09-Mar-2022 16:40
    Hello everyone, given the issues in the Ukraine, how are you managing trials that are ongoing (ie, actively tx pts, data collection, monitoring, data submission, drug supply, safety reporting, HA notifications?).  Thank you!

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    Cynthia Wojtaszek
    VP Regulatory
    Jackson NJ
    United States
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  • 2.  RE: Ukraine and Ongoing Clinical Trials

    Posted 10-Mar-2022 13:15
    I've been monitoring the regulatory space for this and so far have only seen guidance from the Czech Republic. The SUKL (State Institute for Drug Control) has prepared an opinion on the inclusion of Ukrainian patients in clinical trials in the Czech Republic, you can find it here. Based on that, they also issued this guidance to patients:
    Can Ukrainian patients continue in clinical trials after arrival in the Czech Republic?, State Institute for Drug Control (www-sukl-cz.translate.goog)

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    Susan Laufer BA, MSc
    Senior Consultant
    Chicago IL
    United States
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    Original Message


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