ICSR submission to EudraVigilance: Safety DB to comply with new format

February 21, 2022

As of June 30th, 2022, your Safety Database should comply with the new format E2B-R3 for the submission of ICSR to EudraVigilance.

From Asphalion we do not want to miss the opportunity to remind you that, if you are still in process of the new database implementation, we can give you support in various aspects in this transition.

Regarding the configuration of the database, once implemented it is important to take into account the adaptation of the SOPs of the PV system related to the database, including:

    • Sources, workflow and management of Safety Information
    • Data Entry conventions
    • Case management
    • Case Reporting
    • Transmission with Gateway
    • Maintenance of Product Library
    • DB User Manual
    • Quality Control ICSR of Safety Database

Should you need extra support to complete the configuration of the new Safety Database or if you interested in having further details about the support that Asphalion can provide you with, please do not hesitate to book a free 30 min. meeting in the following link:

Asphalion (office365.com)

Alternatively, you can send us an e-mail at: info@asphalion.com


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