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Virtual

Jan 27, 2025 9:00 AM - Jan 31, 2025 1:30 PM

(Central Europe Standard Time)

Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System

Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS.

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Tech Requirements

  • Communication Platform

    Zoom will be used as our communication platform for this training course. To test your system compatibility, click on this link: https://diaglobal.zoom.us/test

  • EMA platform for practical exercises and post course exam (XCOMP)

    The practical exercises and post course exam will be performed in the EMA XEVMPD testing environment (XCOMP). Access requires mandatory pre-course installations.

    1. 1. Attendees need an active EMA account. Please refer to this link for more information: https://register.ema.europa.eu/identityiq/home.html
    2. 2. Detailed step-by-step instructions on how to request the applicable participant role in EMA XCOMP will be shared upon registration.
    3. 3. It is advantageous utilising dual screens.

    1. Note

      DIA is not responsible if system set up is not performed correctly prior to the course and attendees are not able to complete the post-course assessment. Terms and conditions do apply.


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