• RE: Issues with log-in for new IRIS users

    When login is not possible and the message above appears, the causes can be multiple. One attempt that can be made is to use a different browser, and if possible a "InPrivate" window (also called "Incognito" window) to access the system. It has been reported that when a user has multiple Microsoft accounts, of which one with EMA, the browser may become confused and try to open the IRIS portal using the credentials of the other Microsoft account. Using an "InPrivate" window could sort that.

    If this fails, it is necessary to open a Servicedesk ticket to request a re-sync of the account.

    Due to a problem with the integration routine between the EMA Identity and Account Management meeting system and IRIS, and to an increase in submissions and requests due to the return from holidays, EMA Servicedesk is experiencing a surge of requests, so it may take more than usual to perform the re-sync, for which we apologize. EMA IT is aware of the background issue in the integration routine and is working towards a solution. 
  • New "External Organisation Administrator" role in the EMA Account Management system (Super User)

    As detailed in the IRIS Guide to Registration, Industry staff who wish to operate in IRIS on behalf of their organisation(s) need to request affiliation to their organisation's Industry IRIS User Admin, via the EMA Account Management system. Different systems ar EMA however have separate Industry User Admin for each system, which may create complication.

    To address the issue, EMA has created a new "super user" role, the "External Organisation Administrator", which sits on top of the user hierarchy at each organisation. An "External Organisation Administrator" can nominate other Industry User Admins (including the IRIS User Admin) for that organisation, and will directly receive access requests when there is no specific Industry User Admin for a specific EMA system at the organisation.

    The use of the new role is optional. For further information, please consult the "User Administrator Guide" in the EMA Account Management System.  

  • RE: Updated IRIS guide for applicants - Registering an i-SPOC

    Dear Isabelle Picard, as reported in the Home page of these Forums, for access and registration requests and for reporting faults please open a request in EMA ServiceDesk providing as much information as possible (e.g. screenshots)
  • New IRIS affiliation role available: IRIS Industry Coordinator

    The new IRIS affiliation type "IRIS Industry Coordinator" can now be requested in IAM (the EMA Account Management system). 

    Users with this role can  visualize and edit any submission/application made on behalf of the specific organization of affiliation, in addition to those where the user is the creator or has been added as a manager/contributor (as is the case for users with simply an "IRIS Industry Manager" or "IRIS Industry Contributor" affiliation to an organization).

    This is useful, for example, if a previous or ongoing submission was created by a user who then left the company, without any other company users associated to that application. An "IRIS Industry Coordinator" can now see the submission, add himself/herself or any other user affiliated to the same organization as a manager for that submission, and finally change the submission contact (the person who receives all the emails) of the procedure.

    The features above are particularly relevant for Inspection procedures, where the submission record is created by EMA and not the applicant, and assigned automatically to the Product contact person as submission contact: if this person is unavailable or has left the company, it is now possible for any "IRIS Industry Coordinator" to add new Managers and then change the submission contact as desired. 
    Please note that the "IRIS Industry Coordinator" affiliation does not allow to create a new submission of any kind: for that, it is necessary to have the role of "IRIS Industry Manager", in addition to that of "IRIS Industry Coordinator"  for the same organization.  
  • RE: When will MAHs become available for i-SPOC registration?

    Yes the new functionality is already available, no changes in the approval process were introduced, approval of roles can take:
    • up to 2 days for the first user approved by the EMA, which has to be a user with the IRIS Industry Admin role;
    • for all subsequent users and affiliation, approval times depend on the IRIS Industry Admin user(s) at each organisation.
  • RE: When will MAHs become available for i-SPOC registration?

    In general, if an affiliation is visible in the EMA Account Management System, but the organisation is not shown in IRIS when attempting to create a new submission, this suggests that the propagation between the two systems has failed. The re-sync can be obtained via a request to EMA Servicedesk.
  • RE: Organisation affiliation

    Dear Alex Xuereb, your screenshot does display the affiliation in the EMA Account Management System, however this affiliation has not been propagated to IRIS due to a bug, unfortunately. Please submit a Servicedesk Request to have your account re-synced.

    In general, if an affiliation is visible in the EMA Account Management System, but the organisation is not shown when attempting to create a new submission, this suggests that the propagation has failed. The re-sync can be obtained via a request to EMA Servicedesk.
  • RE: When will MAHs become available for i-SPOC registration?

    Dear Susanne Hense, please raise a ticket with Servicedesk. There may be additional problems, specific to your account - a re-sync may be needed. Meanwhile, please make sure that you request the "IRIS Industry Manager" affiliation in the EMA Account Management System, for all organisations on whose behalf you intend to create submissions.  
  • RE: When will MAHs become available for i-SPOC registration?

    Dear Susanne Hense, I have checked your account and you have the IRIS Industry Manager role for only three organisations, and therefore when creating a new submission you will see only those three. You also have the IRIS Industry Coordinator role for many other organisations (>30), but that does not grant you the right to create new submissions on their behalf; it grants you only the possibility to see all existing submissions for those organisations, and add/remove participants (Managers or Contributors) to those existing submissions. We ackonwledge that, unfortunately, the currently published guidance is not clear on this aspect, and the revised version has not been published yet due to a mistake (but it will be soon).

    To be able to create submissions for the companies where you already have only the affiliation as Industry Coordinator, you need to request also (or instead) the affiliation as Industry Manager to each of them. 
  • RE: IRIS doesnt display my Organisation

    Please create a Servicedesk ticket for this type of access problems, as individual requests are necessary.