Caterina Scarpati

The EMA is pleased to announce a public event aiming to provide a comprehensive understanding of Product Management Service (PMS), its use cases in EMA digital services and actions Industry & Network stakeholders should start preparing to take. The info-day will take place on 16 April 2024 (9:15 – 17:30 CEST).
The event will:

• highlight PMS’s enabling role in digital solutions in EMA portfolio such as electronic application forms (eAF), regulatory procedure management (IRIS), electronic product information (ePI) and the future European Shortages Monitoring Platform (ESMP);
• provide an overview of PMS plans – including latest developments, as the go-live of PMS Application Programming Interface (Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), read-only) and Product User Interface (CAPs, read-only), both planned for Q2 2024;
• demonstrate how Substances, Organisations and Referentials (SOR) and XEVMPD services come together to support PMS;
• showcase current practices for both Industry and National Competent Authorities in relation to preparing for PMS data readiness.

This event is highly advised to attend for PMS for those responsible for regulatory data management in their organisations.
Please save the date for this important event.
The session will be broadcasted live on the EMA YouTube Channel.
The broadcast link, agenda and presentation will be available on the event web page.
 

The EMA is pleased to announce a public webinar on Substance, Product, Organisation, Referentials (SPOR) Data Management services update scheduled on 10 April 2024 (10:00 – 12:30 CEST).
SPOR services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, efficiencies, and more efficient regulatory action. Through the integration of its services with other systems used for regulatory procedures, such as IRIS, SPOR actively contributes to their success and full benefits realisation.
During the event, the following information on the SPOR data management services(i.e. SMS, XEVMPD/Art.57, OMS, and RMS) will be provided:

• highlights of 2023-2024
• achievements in Q1 2024
• what is planned for Q2 2024
• what are the key highlights for SPOR users

Please save the date for this important event.
The session will be broadcasted live on the EMA YouTube Channel.
The broadcast link, agenda and presentation will be available on the event web page.
Note that this session will not include updates on the Product Management Service (PMS), as these will be addressed during the PMS Info-Day scheduled for 16 April 2024.
 

From Friday, 12 April 2024 (18:00 CEST) Monday, 15 April 2024 (7:00 CEST), you will experience downtime of IRIS (including IRIS Customer Relationship Management (CRM) software, Industry and Network Portal).
During this period, EMA will load data of Nationally Authorised Products (NAPs) for Human use and Centrally Authorised Products (CAPs) for Human use from its internal database and extended EudraVigilance medicinal product dictionary (XEVMPD) database to Product Management Service (PMS).
This is a crucial step in making further ISO-IDMP compliant, structured and standardised human medicines data available to be used in other EMA systems. This includes the updated CAPs* availability for the web-based Human variations electronic Application Form (eAF) in April 2024 and the upcoming launch of the PMS Product User Interface (view-only, edit functions available later) in May 2024. 
Thank you for your attention and cooperation.
*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.

The IRIS team is currently working on the migration of historical data from closed procedures in SIAMED to IRIS, a necessary measure to optimise IRIS functionality. 

To facilitate this migration, a downtime period for the Industry & Network IRIS Portals is scheduled from 1 March 2024, 19:00 (CET) to 3 March, 19:00 (CET). In this timeframe, the users will not be able to submit or view data. This specific window has been carefully chosen to minimise disruption to IRIS users and ensure a smooth transition.  

Your understanding and cooperation during this period are greatly appreciated. 

Contact Information: If you have any questions, please post a reply in this thread.

If you are keen to know more about the technical aspects of the Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) transition to IRIS and seek specific answers to your technical queries, you are invited to join the RPM Technical webinar. During the session, the RPM team will address key concerns and doubts received from Network stakeholders over the past weeks.
Event Details:

• Date: 27 February 2024
• Time: 10:00 AM - 12:00 PM (CET)

The registration form is available here.
This webinar will be a valuable opportunity for you to gain further understanding of the impacts of the transition of RPM for PLM to IRIS on Network systems.
 

EMA is currently working on the onboarding of Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) for medicinal products on IRIS. The 1^st roll-out occurred on 23 January 2024, covering Variations, Article 61.3 Notifications, and Marketing Authorisation Transfers procedures for a subset of both human and veterinary medicinal products.
The onboarding of regulatory procedures on IRIS will lead in the long term to process simplification and standardisation for MAHs, thus allowing the decommissioning of SIAMED. 
The RPM for PLM team is pleased to announce a public webinar on 13 February 2024, 10:00 - 11:30 (CET). The virtual event is designed to provide a comprehensive overview of RPM plans for the year 2024, offering a glimpse into the strategic direction, key objectives, and upcoming milestones. A focal point of the webinar is a live demonstration of the Industry Portal, allowing participants to explore its features and functionalities.
The event is primarily dedicated to all interested pharmaceutical industry companies (especially individuals with expertise in regulatory affairs). Do not miss this valuable opportunity to enhance your understanding and stay informed about the latest developments in this area.
The registration form is available here.
Registration is open until the start of the meeting. 

The Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) team is pleased to announce the 1st roll-out of Variations, Article 61.3 Notifications, and Marketing Authorisation Transfers on the IRIS platform today, on 23 January 2024. 
Please note the transition only affects a subset of human (67) and veterinary (44) medicinal products with low regulatory complexity. Impacted Industry and Network stakeholders have already been provided with the final list of products.
This significant achievement follows a meticulous testing phase, including a successful second round of testing in November 2023, building upon initial testing conducted in May and June 2023.
Throughout 2024, the RPM team will concentrate on the incremental delivery of additional system functionalities and the development of additional procedures. In particular, the work will focus on Periodic Safety Update Reports (PSURs), Post-Authorisation Measures (PAMs), Line extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Study (PASS), and Referrals. The roll-out for these procedures on IRIS is scheduled for Q4 2024. More details on 2024-2025 plans can be found in the attached RPM roadmap.
The long-term aim of onboarding end-to-end human and veterinary regulatory procedures on IRIS is to increase automation and efficiency, improve knowledge management and data security, and enhance transparency.
For further information or inquiries about RPM for PLM, please contact iris@ema.europa.eu.

EMA is pleased to announce a new public webinar (event page on EMA website) for medicines developers and regulators eager to gain deeper insights into what the Agency's Product Lifecycle Management (PLM) value stream is working on and its goals.

This webinar aims at illustrating the interconnections between the various digital products being delivered. In addition, further insights into the approach taken to enhance product lifecycle management technology in order enable more efficient and effective medicine regulation will be outlined. 

About PLM: 

PLM is one of three value streams covering the product lifecycle implemented by the Agency as part of its Agile transformation. PLM aims to digitally transform and optimise regulatory procedure management as well as data submission and reuse throughout the product lifecycle. The value stream works with EMA partners and stakeholders to deliver systems and services to manage the authorisation and lifecycle of medicinal products and medical devices within the Agency’s remit for the ultimate benefit of public and animal health in the EU.  

About the Webinar: 

During the webinar, participants will learn more about the value stream’s vision and roadmap towards a data centric target operating model for end-to-end data capture, processing and re-use, as well as how PLM’s products and solutions are contributing to this model.  

Featured PLM Products and Solutions: 

• Solutions for Human & Veterinary medicinal products: 
  • electronic Application Form (eAF) 
  • Regulatory Procedure Management (RPM) on IRIS

 

• Solutions for Human medicinal products: 

  • eCTD v4.0 implementation 
  • Product Management Service (PMS) 
  • Product Data Management User Interface (UI) 
  • electronic Product Information (ePI) 
  • Expert Panels for Medical Devices (EXPAMED)

 

• Solutions for Veterinary medicinal products: 

  • Veterinary Union Product Database (UPD) 

What’s in it for Industry and National Competent Authorities: 

This webinar presents a valuable opportunity for Industry and Network stakeholders to enhance their understanding of the work of the value stream and stay informed about the latest developments in this area, ask questions and interact with the responsible EMA teams. 

Registration & Contact details: 

Interested stakeholders are invited to kindly register at the following link. 

Please note registration will remain open until the start of the webinar.  

You have the opportunity to send your questions in advance via Slido.com using the specific event code: #PLMVS-QA.  

Should you have any questions or require further information, please feel free to contact us at plm.valuestream@ema.europa.eu

EMA is pleased to announce further updates on parallel distribution notification forms in IRIS and changes to the public register for parallel distribution notices.
 

• IRIS submission forms for initial notification, safety update and annual update were updated in section “Documents from Applicant” where applicants are required to indicate the document type (mock-up of outer packaging, mock-up of inner labelling and package leaflet) and the language(s) of these documents.
  For detailed guidance please refer to IRIS user guide for parallel distribution applicants which is updated accordingly.  
   
• Register of Parallel Distribution Notices · IRIS (europa.eu) was updated with addition of re-packager field to allow database search now also by re-packager name. Respectively, re-packager column is also included in the list of search results which allows you to export the details of parallel distribution notices in Excel. 

 
More information is available in the updated IRIS user guide for parallel distributors.

For technical support with submission process or data in the public register, please log a ticket in Service Desk; for general enquiries, please send us a question. or post a new thread in the IRIS Forum “General Discussion and Self-Help”.

Good morning Sara,

We confirm the correct name now is IRIS - eAF Industry User Admin.