Dear IRIS Support Team,
I am currently completing a PIP modification in IRIS and need some clarification.
In the EMA’s new KEF V8.0 template, the row names have been updated for an aspect where we are proposing a KBE change. Should the sponsor update and align the terminology accordingly in the relevant row(s) of the Section 2 tables in the Request for Modification, or is alignment not required?
If alignment is required, should we do this for all aspects that have changed in EMA's KEF V8.0 template irrespective of if we propose a change or not?
Thank you in advance for your support.
Tina Bhakta