PIP Initial Submission and use of IRIS from 04 June 2024

We are aware of the introduction of the extension of the IRIS platform from 04-Jun-24 where initial PIP will have to be submitted using the IRIS platform.
We would like to ask for advice on initial PIP applications that are submitted before this deadline using the previous process and how the application will be handled once the 04-Jun-24 timepoint has passed for example if there are validation issues.
Many thanks.
Kind regards

A final decision has still to be made on this issue, however it is likely that for submissions sent before 4 Jun the current (non-IRIS) process will apply, for validation and the initial assessment. Special arrangements may prove indicated for applications for initial Paediatric Investigation Plans, if a Request for Modifications is issued. Please check the What's New in IRIS forum regularly, closer to the go-live of IRIS for Paediatrics, for updated information. 

4thJune is quickly approaching, are you planning to organise a webinar on the use of IRIS for PIP related submissions? I've also noticed the IRIS guidance document do not include any reference to PIP submissions yet. Thanks

There is no plan to hold a webinar specifically for paediatric submissions in the IRIS Industry portal. However, please note that the Paediatric submissions in IRIS were shown in the EMA Quarterly System Demo Q1 - 2024, and that the processes shares most of the steps with the other procedures already managed in IRIS, for example Orphan designations, Scientific Advice or PRIME designation. Video recordings of previous webinars for these procedures are available in the Guidance and Support Section of the IRIS homepage. 
Regarding the IRIS Guide to Applicants (creation of submissions), this is in progress and the updated guidance will be available by the go-live date. 

Could you please clarify how to update the Contact person (for communication with EMA) reflected in IRIS Reg entitlement when is it not correct? According to the What's new forum related post "For Regulatory entitlement the contact person from the applicant and the email for interested parties have been added to the records. It is possible for holder to edit these data directly in the IRIS portal, and to add a telephone number for interested parties, simply by clicking on each blue Entitlement Number (decision number) in the tab “Org. Reg. Entitl.”. However it appears that in case the mentioned name is not in line with the latest submitted record, change of name is not possible, only deletion is. Thanks

For specific issues with a Regulatory entitlement, please Report an issue with IRIS which will create an incident ticket in ServiceNow. Please provide as much information as possible, including screenshots of the portal, any error messages shown, the list of contact persons displayed, and the email of the user attempting to update the information.

For PIP submissions, users are saying that only one contact point can be added so when they are on holiday, how can we add backups. They have confirmed that contributors have been added but the emails are only going to the contact named contact person. . 

While only one "portal contact" (submission contact) at a time is allowed in IRIS, it is possible to change the portal contact any number of times, in IRIS. For draft or ongoing submissions, this allows to replace the portal contact (the only receiver of IRIS communication) among the users associated to the submission as Industry Managers, either temporarily or permanently. This applies to any type of IRIS submissions, not just for Paediatric ones. 
Please see chapter 2.4 of the IRIS Guide to applicants (creation of submissions) document for instructions.