Isha Arora Dr.

Hi, following my last question, I was wondering if the same could/will be applied for the email for public enquiries for Paediatrics Submissions?
1- Can we maintain that via IRIS as well ?
2- If not, how can we request update of emails displayed on EMA webpages ?
Thanks, Isha 

Thank you for your quick reply. This is very helpful.
We appreciate that the EMA standard website will be updated in a timely manner (as currently there may be some mismatch).
 

Hello,
I have a question in regards to the Public List of Opinions on Orphan Medicinal Product Designation, where the email for public enquiries is visible.
1- How is this email maintained, in IRIS or not ?
2- If correct in above mentioned public list, How is the correct email reflected in related EMA webpage ?
Thanks,
Isha 

In the IRIS guide to registration and RPIs, section 5.4, it states the following:
''Every IRIS Industry Manager or Contributor affiliated to an Organisation can see all Regulatory Entitlements associated to the Organisation (such as Orphan Designations and Scientific Advice outcome).''
Where can we see all SA outcomes for an ORG ? can we also extract/download the list for SA?

Hi,
According to IRIS Guide of applicants, "Upon adoption of a GCP inspection, [...] you must update the submission with the necessary information (i.e. Purchase Order (PO) number and requested documents) within 10 working days of the inspection announcement".

1. In regards to PO number, can it be the study sponsor PO number ?
2. Can you confirm it does not have to be the MAH PO number ? (in which case it does not even make sense to ask for it)

I would appreciate your prompt reply please as it could significantly impact the way our internal organisation for fees payment is setup.
Best Regards,
Isha

Hi, I would like to confirm if the deadline of 30-April-2022 for submission of marketing status baselines is still valid, as related EMA tickets have been suspended due to IT improvements/upgrades ongoing in the background.
It's only 9 working days left and it still does not work.
Thanks, Isha

After getting few GMP inspections submissions opened in IRIS, how shall we proceed if we have questions related to the inspection details ?
the IRIS guide says:  

("...If you have any questions related to the inspection case, please do not enter them in the general comments field but address them to the relevant EMA inspection co-ordinator by replying to the IRIS notification you received at the start of the process. When replying, please do not change the subject of the message to ensure the e-mail is correctly routed.").

However, we never got IRIS email related notifications. We just ""discovered" those inspections while going in IRIS.
 

Thank you for the information.
I believe we are talking about v2.4 (not 1.8?) document dated 20 October 2021 ?
There is a section 7.2 added for GCP inspections. Does it mean feature for GCP inspections has been launched ? (or is this only a pre-info as already communicated in trainings?)
 

Hi, I have 2 further concerns please:
1) In regards to excel and ISO codes, this is not resolved. We have noticed that the template that is inserted in the guidance for applicant still reflect Greece with GR instead of EL (as you have mention it above).
2) how is it possible to correct a false entry in IRIS? (e.g a wrong date for cessation in the past ?)
Thanks.

sorry, one more:
7- Can we download all the information received in IRIS in relation to GMP inspection, for communication and coordination within the company different functions ?