Paolo Tomasi EMA

To use IRIS, you need to have been granted at least one of the following affiliation roles for the organisation on whose behalf you will be acting:

A) Scientific procedures (e.g. for Inspections, Scientific Advice, Orphan Designation or Innovation Task Force briefing meeting)

Individual role:

• IRIS Individual User: this role is assigned automatically by system for new accounts, or approved automatically. You should use this role if you will be submitting applications as an individual user, not on behalf of an organisation.

Affiliated roles:

• IRIS Industry User Admin: can assign the other roles to those who request then for the organisation. Please note that an Industry User Admin cannot access IRIS, or create submission, unless the User also gives himself the role of Industry Manager (below).
• IRIS Industry Manager: can create new applications, and edit, submit and withdraw the created applications or any other where the user has been specifically added as Industry Manager.
• IRIS Industry Contributor (this role is automatically assigned also to IRIS Industry Managers): can edit submissions where he/she has been added as a Contributor by a Manager. An Industry Contributor cannot create, submit or withdraw a submission.
• IRIS Industry Coordinator : users with this role can access any submission/application made on behalf of an organisation, and not only those where the user is the creator or has been added as a manager/contributor, with the functions of IRIS Industry Manager. Please note that this role does NOT allow to create new submissions of any kind: for that, it is necessary to also have the role of Industry Manager, for the same organisation.

B) Parallel Distribution procedures

Affiliated roles

• IRIS Parallel Distribution User Admin: can assign the other roles to those who request then for the organisation. Please note that an Industry User Admin cannot access IRIS, or create submission, unless the User also gives himself the role of Industry Manager (below).
• IRIS Parallel Distribution Manager: can create, edit, submit and withdraw applications.
• IRIS Parallel Distribution Contributor: can edit applications (but not create, submit or withdraw them)

Additional information on what individual roles can see in the system is included in the IRIS guide to registration. 

To all IRIS users, and more in general all Industry stakeholders. 

In alignment with the Agency's cloud strategy and the information security strategy, a new IT service management solution called ServiceNow will replace our current tool (Jira), with a target go-live date of 12 September. The first stage of the transition will include the customer portal, IT incidents and IT service requests (IT equipment, applications, audio-visual and virtual meetings), basic configuration management database (CMDB) and the mobile app. From 12 September 2022, Jira will not be any longer available for raising any IT Service request or Incident.

The aim of this improvement is to adapt EMA's processes to the industry best practices and enhance End-user experience, by delivering a more user-oriented service. To familiarize yourself with the new platform, a short Instructional video is available (4 min).

Please follow the link below and enter the password.

Instructional video URL:   https://vimeo.com/showcase/9785767

Password:                         SNtraining2022!!!

For any questions or comments, please send an email to servicenow@ema.europa.eu

For specific problems in IRIS, rather than general aspects of the function of the system, please raise a Servicedesk ticket, including additional information and screenshots. It is not possible to assess and solve/answer this type of requests in a Forum thread, unfortunately.

Due to a problem with the integration routine between the EMA Identity and Account Management meeting system and IRIS, and also because of an increase in submissions and Servicedesk requests due to the return from holidays coupled with the iSpoc deadline, 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.

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. 

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.  
 

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)

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.  

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.

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.