Aleksandra Gurzynska

Thank you for your prompt response. Could you please provide an estimated timeline for when this bug is expected to be resolved? Understanding the timeframe will help us plan our submissions accordingly.

Dear IRIS Team,

I have encountered some discrepancies during the submission of the PIP Annual Report in the IRIS portal. The generated eAF appears to be tailored for an Initial PIP rather than the annual report. Could you please clarify if this is a technical issue, or if it is expected that the eAF for the Annual Report generates sections specific to the initial PIP? 

Specifically, I have noticed the following:

1. Present in Generated Application Form but Not Available to be Filled in IRIS:

   • Procedural Information
   • Completion of Pharmacokinetic Studies in Adults
   • Details on Each Proposed Study/Measure Including Key Elements
   • Waivers
   • Quality Aspects

2. Available Online in IRIS Portal but Not Captured in Downloaded eAF:

   • Annual Report Details
   • Marketing Authorization Information
   • Development Progression

Please find attached screenshots from downloaded eAF for your kind reference.

 

If changes are made to the public email address for interested parties, or if a PIP is transferred to another regulatory entitlement in IRIS, could you kindly inform me about the timeline for these updates to be reflected on the EMA website?

I am reaching out to discuss an issue I've encountered during the transition of Paediatric procedures to IRIS. 

EMA has allocated a specific Industry organization and location as the Paediatric Regulatory Entitlement (Sponsor) for each PIP in IRIS. However, many PIPs need to move to a different Paediatric Regulatory Entitlements, either to a different location within the same organization or to a different organization altogether due to wrong entitlement being assigned by the EMA. This is being accomplished directly in IRIS using the "transfer of PIP or waiver" process type.

The problem I'm facing is that I can't seem to alter the contact person assigned to the individual PIPs after the transfer has been completed. When I attempt to search for a new contact in the "Lookup records" section, no results are displayed, even though my search is limited to individuals with both eAF Applicant Manager and Industry Manager access.

I would greatly appreciate your guidance on how to resolve this issue. If this is something that needs to be addressed from your end, I kindly request your assistance. We would appreciate being able to check who the PIP Point of Contact is within the IRIS database ahead of any potential future PIP-related submissions.