Posted Mon, 04 Oct 2021 09:14:38 GMT by Kathryn Brouder Director, Regulatory Operations
Please can you advise how we contact the Orphan Office?  Is there an email address or an eForm link you can provide?
 
Posted Thu, 07 Oct 2021 11:55:42 GMT by Paolo Tomasi EMA
You do not need to contact any office at EMA to change the Submission contact person (the individual receiving communications from the IRIS system regarding all submissions): this can be done directly in IRIS. Visualise the submission, click on the arrow at the rightmost end of the row (the one used to edit a submission), and select "Manage Submission Contact". Kindly note that the new Submission Contact must already be associated to the submission as an Industry manager, so this step may need to be done first (using the same menu). 
 
Posted Thu, 07 Oct 2021 12:53:01 GMT by Kathryn Brouder Director, Regulatory Operations

This is in relation to the Primary Sponsor Contact, rather than the Submission Manager contact.  On a post from last month to Dr Rainer Paffenholz, you suggested to contact the Orphan Office to change the IRIS Primary Sponsor Contact, but after searching, I cannot find how to do that.
 

Posted Mon, 25 Oct 2021 09:15:07 GMT by Monica Gomar Mengod x
After checking BioMarin records, this enquiry has turned up to be too specific to answer via this channel. The EMA Orphan Office is currently in direct discussion with sponsor outside this portal to fix the contacts and associated access roles for their organisation. 

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