Posted Fri, 20 Nov 2020 12:40:23 GMT by Ian Hardern Mr.
If two companies are co-developing a drug and the company that does not have the RPI registration wants to request scientific advice for a clinical trial that they will be sponsor for, how do they go about requesting SA via the IRIS portal without transferring the RPI registration:
Would their development partner, that has the RPI registration be able to submit the SA request and documents of the other company on their behalf and have the point of contact for communication between the EMA and the SA requestor be from the partner company (who don't have the RPI registration).
Posted Mon, 23 Nov 2020 14:32:46 GMT by Paolo Tomasi EMA
If person X working for Company B, which does not "own" the RPI since Company A does, wants to create a submission for that RPI and be the portal contact for the submission, then person X can ask an IRIS Industry Manager role to Company A (owning the RPI). In this way, person X will be the portal contact, the RPI will remain assigned to Company A, and the outcome of the SA will be in the name of Company A.
 
Posted Mon, 23 Nov 2020 15:08:17 GMT by Ian Hardern Mr.
Thankyou Paolo for your response.
If I understand your response right  - you are saying that  person X  would ask to be an affiliated IRIS industry manager to Company A.  My understanding of this route is that person X, having been granted affiliation to Company A, would then be able to see all Regulatory Entitlements and Research Product Identifiers for Company A.
If, because of potential confidentiality / legal issues caused by the affiliate (person X) being able to see all of Company A's Regulatory Entitlements and Research Products Identifiers (not just the RPI subject to the collaboration agreement between Company A and Company B), affiliation to Company A as an industry manager is not feasible, how can company B request SA for their CTAs without transferring the RPI?

If an RPI was to be transferred between Company A and Company B multiple times, can both companies have parallel active submissions in the IRIS portal using the same RPI ?
e.g. Company A submits a SA one month, then transfers the RPI to Company B who submits a SA in time for the following months procedure and having done so then transfers the RPI back to Company A, both Companies would have SA procedure on-going that are linked to the same RPI. Would this be allowed / feasible?    
Thanks in advance for any assistance you an provide at this time.
As you can see there are potential issues with submissions through the IRIS portal using the same RPI which is subject to a collaborative agreement between two companies and I am trying to understand what options there currently are for two companies to "share" an RPI for submissions through the portal, without compromising potential confidential information.
Posted Tue, 24 Nov 2020 09:04:07 GMT by Paolo Tomasi EMA

Your understanding is correct. A EMA user affiliated to an Organization can see all the RPIs "owned" by that organization, and all Regulatory Entitlements assigned to that Organization. This is necessary to allow the person to submit applications that require reference to an existing RPI or an existing Regulatory Entitlement belonging to that organization. 

It is not possible to grant selective access to RPIs "owned" by an organization. The only strategy in this case would be to transfer the RPI temporarily to Company B, which then would be the applicant and would receive the outcome of the procedure. Once the application is submitted, the RPI can be transferred back to Company A (or to a third company).

Multiple parallel procedures with same RPI, but from different applicants, should be possible in IRIS. 

RPI transfers can be performed by the current "owner" directly in IRIS, and the procedure is completely automated. 

Posted Tue, 24 Nov 2020 09:11:14 GMT by Ian Hardern Mr.

Thank you for your confirmation and clarity of response. It's very much appreciated.

Posted Mon, 30 Nov 2020 10:15:14 GMT by Ian Hardern Mr.

Continuing the same thread and thoughts as the last answer provided:

Hopefully one last question regarding the RPI transfer and the  Company B point of contact for the Scientific Advice submission.

Once a Scientific Advice submission has been submitted and Company B transfers the RPI back to Company A, I would just like to confirm that all correspondence associated with the Scientific Advice submission by Company B  will be sent to the Industry Manager of Company B who did the submission, even though the RPI has now transferred back to Company A. I suspect this would be the case, as the contact is associated with the submission and not the RPI, but it would be good to get confirmation of that.

Thanks in advance for your continued assistance. 

Posted Tue, 01 Dec 2020 07:49:37 GMT by Paolo Tomasi EMA
Your understanding is indeed correct!
 

You must be signed in to post in this forum.