Posted Tue, 04 Feb 2025 11:17:33 GMT by Angela Pizzatti

I need to submit a PIP modification to remove two Studies from the initial agreed plan. When completing the field in IRIS, coming to "Scientific information" how should I complete the part : Please provide all details on each proposed study/measure to be included in the new PIP Decision. For modified studies, include the same number/code as in the latest decision received for this PIP.?

Should I add the two studies that I want to be removed? and in this case how can I make clear that these studies are not new and instead they need to be removed? Could you please advise on the correct steps to follow?
 
Posted Thu, 06 Feb 2025 08:46:18 GMT by Giovanni Lesa Dr
In IRIS you should only include the key elements of the studies that are proposed to remain in the PIP. 
You should also fill-in the form entitled "Request for Modification of an agreed Paediatric Investigation Plan", where you should specify all the requested changes, including the studies that you want to be removed and justify why. If you want to remove an entire study, you need to mention the study number in the form; you don't need to write down each key element.
Please also refer to the guidance document published on the EMA web site entitled "Procedural advice on paediatric applications".
Posted Thu, 06 Feb 2025 13:39:02 GMT by Angela Pizzatti
Thank you for your response. I am still unclear about what needs to be included in the "Scientific Information" section. Should I include all the studies except the two we plan to remove, even if no changes are being made to the remaining studies? The guidelines state that we should "Include only the proposed modified key elements. If key element is not changing please add N/A in the mandatory field." However, the system requires at least one entry to validate the section and proceed. Is there a way to bypass this requirement?
Thanks
Posted Mon, 17 Feb 2025 12:59:11 GMT by Giovanni Lesa Dr
Yours is a case we see rarely: you would like to delete two studies from the PIP without proposing any study to replace them or any change in the other PIP studies.
The IRIS form requires at least one study to be entered and there is no way to bypass it. Thus, you could enter the details of all the studies that you request to remain in the PIP Opinion, even though you do not ask for any change in them.
In the scientific part you will send with your request of PIP modification, please make the above clear and explain what you have entered in the IRIS form and why.

You must be signed in to post in this forum.