Isha Arora Dr.

Thank you for those answers. However, I have some more questions please:
1- From 1 October 2021 (last Friday), MAH and applicants need to use EMA's IRIS system to communicate with EMA on GMP inspections requested by the Agency’s scientific committees. The video recording of the training for Industry held on 10 September is still missing publication.

2- Our understanding is that if more than one product is in scope of the GMP inspection for one site, several product contact get the IRIS notification. Can you please confirm that all product contacts will have to enter the Purchase Order number, for each submission/product ?

3- What exactly will be charged on the PO number provided, e.g. only the inspection fees, or also travel and accommodation costs of the inspectors ? How can a company separate PO for inspection fees from PO for travel and accommodation costs of the inspectors ?

4- IRIS notification will be generic (assumption) and only to one person (as informed only to the Product Contact for the application already notified to EMA, which is often the portal contact as well), which is a risk in terms of speed and eventually availability of this person (if he/she is out of office). What is done to limit this risk? Can we provide to EMA a generic email address to be copied for all inspections notifications?

5- Will the exchange of information with inspectors be handled in IRIS (steps after submission of PO still not clear) ?

6- Will the GMP inspection report be handled in IRIS (still not clear)?

Thank you in advance,
Isha

 

Hi,

1. I have noticed that in the new IRIS guide for applicants v2.2, dated 17-Sep-2021, a new section has been added for GMP Inspections. It is stated that "Upon adoption of a GMP inspection request by the CHMP or CVMP, the user will receive a notification from EMA indicating that an inspection request has been adopted by the relevant committee (CHMP or CVMP) for one of their products. At that point, you must update the submission with the necessary information (e.g. Purchase Order number) and submit it via the IRIS Portal." Can you please specify who is meant by "the user" ? Who exactly receive the information ? 
    
2. Is there any training video available about this new feature?
    
3. Another new "Guidance for applicants/MAHs involved in GMP inspections coordinated by EMA Version 1.0" has also been released, what is the purpose of having a separate other guidance?
    
4. Will the GCP Inspections be added as well, and when?

Thanks,
Isha 

Hi, we have noticed that the SAWP dates for 2021 have been recently updated. 
This have impact on several Scientific Advice application submission via IRIS and start of their procedure.
To assess the impact, it would be good to have a comparison with the previous version of the document. Would it be please possible to provide us with a track change version of the document ? Thank you.

Dear Paolo,
Thank you, this is very useful information. Could you please include the full information as stated into the IRIS guide for applicants ? As for the moment, reading through the guide, it seems like it is possible to select contact person only at draft submission.
Best Regards,
Isha
 

Hi, this is a general question about timelines to be respected for SA applications and IRIS system features/notifications.
1- For example, for the next SA with preparatory meeting, the applicant has to submit application via IRIS by 30-Oct, right? and not on 30-Oct ? This is a general question that the document "Dates of 2021 SAWP meetings and submission deadlines" still refers to deadlines dates by when the applicant should submit, and not actual date for submission in IRIS?
2- How does it work afterwards, can the applicant still edit the application? or is it system locked for validation phase? will the applicant be automatically notified when editing would be possible again to provide final application ?
We would like to have some detailed information please on how the SA process is supported by the system exactly (deadlines, ability to edit, status for submission / notifications).
Thank you in advance,
Isha

When will the recording be published on IRIS website (guidance & support) for "How to submit initial and follow-up scientific advice applications (human) using IRIS" ?

Will the "IRIS General Manager"' role be assigned to individuals only or will it be possible to register a generic email address for that role ?

I would like to clarify my point 4-:
If an individual tick the declaration box "is authorised on behalf of the applicant", however is not authorized to (i.e change of function within the company, or left company recently and rights have not been revoked yet), how the respective responsibilities (individual/company) are understood?

The new feature "Regulatory Entitlements" in IRIS is quite informative, thank you.
It is understood that the feature enables to see a list of all regulatory entitlements for organisation(s) the person is affiliated to.
However, it is not possible to access and see the actual submission package, would it be possible to implement either a "view & download the submission" feature or a new IRIS Industry role (ideally for a generic email address) who will allow to view only and download all the submission packages for an organization ? This would be useful mainly for archiving purposes and knowledge sharing within the organization.

In regards to Q&A 1, IRIS Industry General Manager role,

• Where do we stand with this ?
• Will this role be assigned to individuals only (as today with other roles) or will it be possible to register a generic email address for that role ?