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.

Tech Requirements

For this online training course, it is advantageous utilising dual screens.

Zoom will be used as communication platform. Please check system requirements: View the System Requirements

EMA EV XCOMP platform

The practical exercises will be performed in the EMA EV testing platform (XCOMP).

As a pre-requisite,

attendees need an active EMA account. Please refer to this link for more information: https://register.ema.europa.eu/identityiq/home.html

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

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

Tech Requirements

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