• RE: Marketing Status Reporting

    Thank you very much for this fast and comprehensive answer :-)
  • Marketing Status Reporting

    Dear All

    My colleagues in regulatory affairs have several questions concerning the upcoming use of IRIS for marketing status reporting e.g. :
    is it still planned to launch of marking status reporting in IRIS in the first week of December (this date is mentioned here in the forum)?
    Will there be a staggered roll-out? Meaning the newly granted MA first, followed by older authorised CP products?
    Will the launch data be available for the public?
    Will the use become immediately mandatory or optional?
    Will marking status data of CP products be migrated or do users have the enter all dates?
    Will the same granularity be used as for the current EMA template/notification?
    Will training to be offered?

    Kind regards, Susanne

  • RE: IRIS Release Information - Week of 14 September 2020

    Dear Carlotte,
    thank you for this nice overview on what is new!
    I did a transfer of a RPI - and it work well.

    With the update of the "Regulatory Entitlement" tab the attribute "Status" is no longer available: now it is no more possible to distinguish between active or withdrawn applications.
    Is it planned to add this attribute again?
    Kind regards, Susanne
  • RE: Technical specification

    Thank you, Paolo!
    For SPOR also the technical doucments are available on the SPOR homepage. Perhaps IRIS techincal documents could also be made public available on the nice new IRIS homepage?
    Kind regards, Susanne
  • RE: Technical specification

    Dear Paolo

    our RIM team is interested in the IRIS data model: which data objects and attributes are needed in which context (relation) and the correspondig RMS list to be used.
    Therefore, it would be great if you could provide a technical specification of all data fields in the IRIS portal (e.g. label, type (date, numeric value, String), related picklist values, ...).

    These information is required in order to support the processes around the IRIS portal in an optimal way.
    Many thanks in advance, Susanne

  • Technical specification

    Where can I find the technical specification document for IRIS?