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News

28-04-2022

Invitation to register to DADI-PMS Webinar - “Variations Form for Human Medicinal Products - What will happen at Go-Live”, 16/05/22 h. 10:00-12:00 (CET)

The Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms, making the future form-filling and submission-handling process more efficient.
The variations form for human medicinal products will be the first form to be released by DADI, with an expected go-live in October 2022. As part of the go live, DADI will expose medicinal product data that have been migrated to the Product Management Service (PMS) for product master data for human medicinal products.
EMA is pleased to announce a new public webinar focused on what will happen at go-live of DADI human medicinal products variations form and its interaction with Product Management Service (PMS).
This public webinar is for business and technical audiences from industry and national competent authorities wishing to learn more about what will happen when the DADI web-based form for human medicinal products will go live. All stakeholders interested in DADI and its interaction with PMS are welcome.
Topics addressed in this webinar include:
  • The process for selecting products, creating and submitting the variations form;
  • Data in the form coming from PMS;
  • The process after the approval of the variation;
  • Need to provide data to the Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
If you wish to attend, kindly register at the following link.

DADI-PMS Webinar Agenda - Variations Form for Human Medicinal Products - What will happen at Go-Live

Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.

31-03-2022

Recordings from the DADI public webinars held on 18th and 25th January 2022 now available

The recordings from both DADI public webinars held in January are now available. Please find the links below (under heading DADI webinars).

10-03-2022

Digital Application Dataset Integration (DADI) Network Project Technical Webinar (FHIR) 25/01/2022 - Presentation and the FHIR mapping and examples now available

Please find the presentation and the FHIR mapping & examples the webinar on "Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF" in the following link. Please note that the recording from the webinar will be published as soon as it becomes available.

And

System demo: digital application dataset integration (DADI) and Product Management Service (PMS) - Live broadcast available

EMA has announced the first public system demo of 2022. In this system demo, EMA will demonstrate developments of DADI project and the PMS service. The system demo will take place on Tuesday 15 March 2022 at 09:00-11:00 (CET). As the original WebEx webinar has reached maximum registration, the EMA team is pleased to inform you that a live broadcast will be available on the day to allow additional interested colleagues to attend the session.

No registration is required to follow the live broadcast on EMA's website, available from the event page. Kindly note the session will also be recorded and made available through EMA Corporate Website.

Please share any questions on the above system demo with us at eSubProgofficer@ema.europa.eu.

17-02-2022

DADI Project updated Questions and Answers document now available

The Digital Application Dataset Integration (DADI) Network Project team is pleased to announce that an updated version of the DADI Questions and Answers documents is now available.

For general inquiries, please contact the DADI project team via eSubProgofficer@ema.europa.eu. For questions or comments around the content of this Q&A document, please raise a ticket (by selecting “Ask a question” and including in the subject “DADI Q&A”) via the EMA Service Desk.
If you have a technical question about the DADI project, please raise a ticket (by selecting “Ask a question” and including in the subject “DADI”) via the EMA Service Desk.

04-02-2022
Following the announcement on the revised timeline made during the first Digital Application Dataset Integration (DADI) Network Project public webinar held on 18 January 2022, an updated timeline for the release of DADI web-based variations forms for Human medicinal products, including key milestones, is now available.

Please note the target go-live date of April 2022 has been revised to October 2022.

  • Currently, the variations form for human medicinal products is undergoing closed User Acceptance Testing (UAT) with members of the DADI Subject Matter Expert Group, which will be followed by testing of the PMS data (through a PMS UAT) that the forms will use. More information around the PMS UAT will be shared during Q1 2022.
  • Finally, there will be an integrated User Acceptance Testing in Q2 2022 with a larger, but still limited, group of testers representing various stakeholders.
  • The go-live will be followed by a 6-month transition period during which both the PDF eAF and the web-based form can be used in parallel.
  • DADI Human Variations Form Timeline (February 2022) New

Further details on User Acceptance Testing and subsequent development on other forms will be shared on a regular basis during the coming months via the eSubmission website.

Send your questions about the DADI project to eSubprogofficer@ema.europa.eu.

And
Presentation from the first DADI public webinar held on 18 January 2022 now published

Please find the presentation from the webinar available at the following link. Please note that the recording from the webinar will be published as soon as it becomes available.

DADI documentation:

DADI webinars:

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

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