Change of a contact person in IRIS Regulatory Entitlements

I am reaching out to discuss an issue I've encountered during the transition of Paediatric procedures to IRIS.

EMA has allocated a specific Industry organization and location as the Paediatric Regulatory Entitlement (Sponsor) for each PIP in IRIS. However, many PIPs need to move to a different Paediatric Regulatory Entitlements, either to a different location within the same organization or to a different organization altogether due to wrong entitlement being assigned by the EMA. This is being accomplished directly in IRIS using the "transfer of PIP or waiver" process type.

The problem I'm facing is that I can't seem to alter the contact person assigned to the individual PIPs after the transfer has been completed. When I attempt to search for a new contact in the "Lookup records" section, no results are displayed, even though my search is limited to individuals with both eAF Applicant Manager and Industry Manager access.

I would greatly appreciate your guidance on how to resolve this issue. If this is something that needs to be addressed from your end, I kindly request your assistance. We would appreciate being able to check who the PIP Point of Contact is within the IRIS database ahead of any potential future PIP-related submissions.

A contact person is assigned for most paediatric regulatory entitlements (PIPs or waivers granted) and is visible to the IRIS Industry users who are affiliated to the organization, only in the IRIS Industry portal. This contact person can usually be reassigned to another IRIS manager associated to that organisation. However, due to a glitch in the synchronization between OMS, IAM and IRIS, newer locations of a pre-existing parent organization are not associated automatically to all the users who are affiliated to the parent organization. As the popup list shows only users affiliated to the location that owns the Regulatory Entitlement, it may contain a reduced number of individuals, or none at all. EMA is aware of the issue and a fix is under development; meanwhile, a potential workaround is transfer the RE to another location of the same parent organization, such as the legal seat or an older location, where more users are associated.

Please note that the contact person for a regulatory entitlement is not published, and is only stored in case EMA needs to contact the RE holder outside of an ongoing procedure. Consequently, there is no obligation for Industry to ensure that information is updated frequently.

On the other hand, the contact email and telephone number for interested parties are not affected by the described glitch; since EMA plans to make that information public in the IRIS Paediatric Register in the near future, it is important to maintain the information in those two fields updated.