Posted Thu, 10 Feb 2022 15:49:58 GMT by Isha Arora Dr.
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.
 
Posted Fri, 11 Feb 2022 08:38:51 GMT by Dunja Vukic
Thank you for the question and apologies for the lack of notifications. One of my colleagues will e-mail you to discuss your questions and issues.
 
Posted Thu, 10 Mar 2022 18:55:23 GMT by NADIA YONIS Europe Platform Regulatory Coordinator
<br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666">According to the answers provided in the thread about “GMP inspections in Iris” which is now locked:</span></span></span></span></span><br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666">- In case of prolonged absence, the contact person can contact the Inspections Office for specific arrangements.</span></span></span></span></span><br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><strong><span lang="EN-US" style="font-size:11.5pt"><span style="background:white"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666"><span style="font-weight:normal">- In the future, a feature to allow direct self-management of product contacts by Industry in IRIS should be developed and this requires the implementation of a Global Coordinator role. An "IRIS Industry Global Coordinator" will be able to manage every submission for the Organisation(s) he/she is affiliated to, with that role.&nbsp;</span></span></span></span></span></strong></span></span><br> <span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666">As regards this 2 topics we have additional questions:</span></span></span></span></span> <ol> <li><span style="font-size:11pt"><span style="color:#666666"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif">Could you provide us with the details of the Inspection Office to contact ?</span></span></span></span></span></li> <li><span style="font-size:11pt"><span style="color:#666666"><span style="line-height:150%"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="line-height:150%"><span style="font-family:&quot;Segoe UI&quot;,sans-serif">Do you know when approximately the new role of "IRIS Industry Global Coordinator" will be implemented?</span></span></span></span></span></span></span></li> </ol> <span style="font-size:11pt"><span style="background:white"><span style="font-family:Calibri,sans-serif"><span lang="EN-US" style="font-size:11.5pt"><span style="font-family:&quot;Segoe UI&quot;,sans-serif"><span style="color:#666666">Thank you. </span></span></span></span></span></span><br> &nbsp;
Posted Mon, 21 Mar 2022 14:08:10 GMT by Dunja Vukic
Please see the answers below:
  • please open a Service Desk ticket and provide as much details as possible.
  • It is planned for Q2.
I hope this clarifies.

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