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RE: IRIS User Admin Role
Good morning Sara,
We confirm the correct name now is IRIS - eAF Industry User Admin. -
EMA Account Management training webinar - 3 October 2022
EMA's Account Management portal is the gateway to using EMA applications such IRIS, electronic application forms (eAF), EudraVigilance, the Clinical Trials Information System and Union Product Database.
EMA has launched a project to ensure that the registration and access-management process delivers a simple, secure, consistent and user-friendly way for stakeholders to work with EMA.
This webinar is an opportunity for industry and national competent authorities to learn more about access-management aspects and procedures for requesting and managing access to EMA applications. The session will take place on 3 October 2022 via Webex at the following time: 10:30 - 12:30 Amsterdam time (CEST).
If interested to participate, you can register at the following link.
A video recording will be available after the event.
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EMA coordinated CHMP/CVMP requested GVP Inspections available on the IRIS Portal from 12/09/22
EMA is pleased to announce the launch of the GVP Inspections feature in the IRIS platform. With the implementation of this new feature, Marketing Authorisation Applicants/Holders as well as EU/EEA inspectorates will be able to interact with EMA via a single portal for the exchange of documents and information on GVP Inspections procedures.
This is expected to streamline the Inspection co-ordination process, ensure more secure information exchanges, and increase data quality through integration with other EMA master data systems (e.g. SPOR).
For more information please check the updated IRIS guide for applicants and the Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections co-ordinated by EMA.
Kindly note a recording from the training session on GVP for Industry users will be made available from the IRIS portal section “Additional guidance & training videos”.
If you have general questions with regard to the IRIS feature on GVP Inspections, please post a new thread in the IRIS Forum “General Discussion and Self-Help”. If you have technical questions or issues please raise a ticket via the new EMA ServiceNow system.
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RE: Updated IRIS guide for applicants - Registering an i-SPOC
Yes, a person with "Industry manager" role can nominate himself/herself for MAH i-SPOC (only consideration is that the user should be affiliated in IAM).
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RE: The webhook call failed because the http request received non-success
For this kind of technical issue, you should submit your request to the EMA Service Desk by using the EMA Service Desk Portal.