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Previous DADI news

24-05-2022

DADI Project Human variations forms updated timeline & revised go-live scope

DADI Human Variations Form Timeline (May 2022)

Following the publication of the DADI timeline in February 2022 please find an updated timeline for the release of web-based variations form for Human medicinal products, including key milestones.
  • 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 is expected to conclude in August 2022.
  • Subsequently, there will be external User Acceptance Testing with a larger, but still limited, group of testers representing various stakeholders. The product team have rescheduled the external UAT from Q2 2022 to September 2022. More information around the UAT organisation will be communicated in June. The UAT will serve to test the system's functions. It will not be set up to facilitate early access to the web user interface for a large group of users.
  • The target go-live date for the release of the form remains unchanged (October 2022).
Scope of Initial release of Human Variations eAF web form

At initial release of the Human variations form in October 2022, the scope will primarily cover a conversion of the current interactive PDF format eAF form to the new web-based format where the main change is to select the product/presentation impacted by the variation from PMS. Future releases will progressively replace more free text data fields with structured data fields. Additionally, the web forms will introduce mandatory use of OMS for all procedure types which is new for non-Centralised procedures.

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.

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.

14-01-2022

Digital Application Dataset Integration (DADI) Network Project Webinar 18/01/2022 - Live broadcast available

In a previous news published on 10 December 2021 EMA announced the upcoming webinar "Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms" on 18 January 2022 at 10:30-12:00 Central European Time (CET). As the original WebEx webinar has reached maximum registration, the DADI Network Project 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. The updated guidance enters into force 1st February 2022.

No registration is required to follow the live broadcast on EMA's website available from the event page and from EMA's broadcasting channel

At certain points throughout this session, participants will be able to ask questions and give their input via the audience interaction tool Slido. Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to the processing of your personal data as explained in the EMA Data Privacy Statement for Slido

Kindly note the session will also be recorded and made available through EMA Corporate Website.

Thank you for forwarding this message to your affiliated Members who wish to participate.

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

10-12-2021

Invitation to register to the Digital Application Dataset Integration (DADI) Network Project Webinars

The Digital Application Dataset Integration (DADI) Network Project will replace electronic application forms. EMA is pleased to announce public webinars to learn more about DADI and aspects of the new web-forms. The first webinar is a general introduction, while the second webinar will focus more on technical aspects of the new electronic Application Form (eAF) setup. Please note these events are organised as part of the change management activities for the DADI project.

Webinar 1 - "Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms"
18 January 2022 at 10:30-12:00 Central European Time (CET)

This public webinar is for Human & Veterinary Medicines Industry and National Competent Authorities' (NCA) stakeholders that wish to learn more about:

If you wish to attend, kindly register at the following link.
Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.


Webinar 2- "Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF"
25 January 2022 at 10:30-12:00 Central European Time (CET)

This second public webinar is for technical experts from Industry and NCAs that wish to learn more about the design of the FHIR message for the first form to be updated: Human Variations. Despite the focus on Human at this time - any stakeholders interested in the technical aspects of the FHIR message are welcome. Topics that will be addressed in this webinar: If you wish to attend, kindly register at the following link.
Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.

17-06-2021
Following up on the initial announcement of the DADI project in March 2021 the project team has released a questions and answers document on the project.

  • DADI Questions and Answers (June 2021) New
  • The aim of the document is to provide the best available answers to questions about the project.

    • What will the DADI project do?
    • Why is DADI being started now?
    • Will DADI Deliver forms complying with veterinary Medicines regulation?

    The team aims to further release in July:

    • The timeline for the coming year, including key milestones and expected stakeholder engagement activities
    • The full list of features of the human variations form
    • Drafts of the variations form FHIR message
    Please keep an eye on updates on this portal for the latest news on DADI.

    The DADI project will replace current PDF format electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based forms will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard. The implementation of these new forms supports the EU ISO IDMP (Identification of Medicinal Products) standards implementation for human medicines.

    DADI is part of the Telematics portfolio and supports medicines life cycle management. It incorporates the learnings and developments of the CESSP phase 1 project.

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

    25-03-2021
    The Digital Application Dataset Integration (DADI) project will replace the current PDF-file based electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based system will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard, and, as a result, with the EU ISO IDMP (Identification of Medicinal Products) standards implementation for human medicines.

    DADI is part of the Telematics portfolio and supports medicines life cycle management. It incorporates the learnings and developments of the CESSP phase 1 project.

    The governance structure for DADI was established in December 2020, following the endorsement of the project charter by the EU Telematics Management Board (EU TMB). The steering group is comprised of the IT Directors Executive Committee (IT DEC) and the EMA accountable executive.

    The project plan, including relevant industry consultation steps and timelines, is under elaboration. Furthers update on the planning and timelines will be shared in due course. The variations application form (Human and Veterinary) will be the first area of focus.

    The DADI project aims to accommodate the requirements driven by Veterinary Medicines Regulation (Regulation (EU) 2019/6) implementation. We will provide a further update on the planning and timeline by May.

    Direct your questions about DADI to eSubprogofficer@ema.europa.eu
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