Previous DADI news
27-07-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.10 released to production on the 26 of July 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
12-07-2023
Human variations web-based eAF Timeline Review
We inform you that the timeline of the variations web-based electronic Application Form (eAF) for Human medicinal products has been updated.
EMA is continuing development work with the aim to incrementally build the new web-based eAF, leveraging on Product Management Service (PMS) data. The key priority for the Agency is to ensure that the eAF is supported by a stable system with high-quality data before starting any transition. During recent testing, it became clear that the target date for the release of split CAPs and NAPs on the PLM Portal requires to be extended. This is due to the additional time needed to perform checks on data quality and the quality of the data transfer of NAPs data, investigate and address potential issues connected to product data transfer and (if needed) repeat the loading of the data.
Therefore, in order to respect our commitment to ensuring that all stakeholders are kept informed on key milestones with reasonable advance notice, please be informed of the new target dates for the release of split Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) for use in web-based eAFs on the Product Lifecycle Management (PLM) Portal:
- release of split CAPs, making them available to use in the eAF, is now expected in October 2023 instead of July-August 2023
target date for the release of NAPs is now expected between November 2023 and February 2024 instead of July-August 2023.
Consequently, the human variations web-based electronic Application Form (eAF) target timeline (last published in April 2023) has been reviewed. Please find here the updated version, which reflects the target dates for each milestone. Kindly note the eAF team expects to provide a further update to confirm the timeline in September 2023, based on latest testing outcomes.
Please be informed that key milestones following split CAPs and NAPs release in web-based eAF on the PLM Portal will be consequently rescheduled. In particular, the external User Acceptance Testing on the version of the web-based eAF intended to replace the PDF and trigger the transition will be rescheduled from November 2023 to a yet-to-be-defined date which will be announced at least two months in advance, as per prior commitment. The transition period will also be announced in due time.
Please note that EMA is following the previously communicated development steps for the products' release on the PLM Portal:
- Load product data into the test environment;
- Test data quality and quality of the transfer;
- Investigate issues, address them and repeat the first 2 steps;
- Once ready, transfer product data into the production environment.
In the meantime, applicants are encouraged to use the human variations web-based eAF already available in the PLM Portal for products already in the system and maintain high the level of data quality of their products in XEVMPD.
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
13-06-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.9 released to production on the 12 of June 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
15-06-2023
Planned maintenance of the eSubmission systems on 17 June 2023
Due to planned maintenance, the eSubmission systems (including eAF and PLM Portal eAF) will not be available on Saturday 17 June 2023, between 8:00 and 16:00. For any further information, please contact Service Desk.
13-06-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.9 released to production on the 12 of June 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
17-05-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.8 released to production on the 16th of May 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
16-05-2023
eAF-PMS Newsletter Issue 3
We are pleased to announce the third edition of the eAF-PMS newsletter is now available at the following link.
This newsletter, available to pharmaceutical companies and National Competent Authorities (NCAs), offers updates on the progress of eAF and PMS, presenting an overview of past and future activities.
In particular, we would like to highlight the following topics:
Upcoming webinars (more details on single events are available in the newsletter):
- Product Lifecycle Management (PLM) Portal Access Management Training Session (25 May 2023, 11:00 - 12:30 Central European Summer Time (CEST)): registration link
- Product Management Service (PMS) Progress Webinar (30 May 2023, 10:00 - 11:30 CEST): registration link
- eAF-PMS Joint Webinar on Nationally Authorised Products (NAPs) Data Release on PLM Portal eAF (8 June 2023, 10:00 - 11:30 CEST): registration link
Updated documents:
Human Variations eAF-PMS Frequently Asked Questions (FAQs) document
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
24-04-2023
Web-based Human Variations eAF (DADI) - Updated timeline
We are pleased to inform you the updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available on the PLM portal Forum at the following link. In addition, we invite PLM Portal users' feedback on the Portal and web-based eAFs through a survey you can find below.
Note in particular the following periods:
| June 2023 |
Start of data transfer - Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) for use in eAFs - the first NAPs products will appear in the eAF. This will allow users to start preparing web-based eAFs for NAPs as these products become gradually available on the PLM Portal; |
| August 2023 |
Expected completion of data transfer - all CAPs and NAPs available in eAF; |
| November 2023 |
User Acceptance Testing (UAT) on the version of the web-based eAF intended to replace the PDF and trigger the transition; |
| Q1 2024 |
Confirmation of transition period start date, approximately 2 months in |
| Q2 2024 |
Start of 6-months transition to mandatory use of web-based eAF for Human Variations. This is subject to a successful outcome of the UAT. Note that the transition period may start earlier, if feasible, respecting the 2- month advance notice period. |
(Further detailed information on impacts for eAF Users, can be found in the 2nd page of the document link.
Please note:
- Functionalities required for mandatory use are being released incrementally: all required functionalities will be available on the PLM Portal before the start of the UAT.
The use of the web-based eAF will follow the current process for updating data. Use of structured data will be implemented at a later point.
The capability to view migrated PMS product data in the Product User Interface on the PLM Portal is under development in parallel - delivery timelines will be announced at a later date.
Details on how the UAT will be organized will be shared in due course.
and
24-04-2023
Feedback Survey for PLM Portal Users (New Deadline: 8 May 2023)
We kindly ask you to provide your feedback on your experience with the new eAF and the PLM Portal, by responding the survey at the following link: https://ec.europa.eu/eusurvey/runner/Adoption-survey-eAF-HumanVariations
This survey aims to gather your feedback on the level of adoption of the change, including the potential concerns or issues you are facing, in order to enable the eAF product team to envisage appropriate fixing and/or mitigation activities.
Please note that the survey will be anonymous, and the results will not be publicly disclosed.
This survey was already shared with PLM portal users in March 2023 and was intended to close on 31 March 2023, but the deadline for responding is now extended to 8 May 2023.
For more insight on eAF, you are invited to consult the following Q&A documents and sessions:
Training Q&A document (link) addressing questions raised by users during earlier eAF (DADI) trainings;
Human Variations eAF go-live Q&A session (link);
Human Variations eAF go-live training session (2 February 2023) (link).
Please send any questions to eSubProgofficer@ema.europa.eu or via the PLM Portal Forum.
19-04-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release Notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.7 released to production on the 18th of April 2023 are now available on PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
21-03-2023
Feedback Survey for PLM Portal Users (Deadline: 31 March 2023)
Following the launch of the Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the Product Lifecycle Management (PLM) Portal, we appreciated many users have accessed the PLM Portal to work on variation applications using the new web-form.
We kindly ask you to provide your feedback on your experience with the new eAF and the PLM Portal, by responding the survey at the following link: https://ec.europa.eu/eusurvey/runner/Adoption-survey-eAF-HumanVariations
This survey aims to gather your feedback on the level of adoption of the change, including the potential concerns or issues you are facing, in order to enable the eAF product team to envisage appropriate fixing and/or mitigation activities.
Please note that the survey will be anonymous and the results will not be publicly disclosed. The survey will stay open until 31 March 2023.
This should not take more than 5 minutes.
17-03-2023
Planned maintenance of the eSubmission systems on Saturday 25 March 2023
Planned maintenance of the eSubmission systems on Saturday 25 March 2023
The eSubmission systems are unavailable for planned maintenance and will be unavailable from Saturday 25th of March 2023 08:00 until 18:00 due to essential maintenance. For any further information, please contact Service Desk
09-03-2023
Updated variation FHIR mapping and conceptual data models
The Variation FHIR mapping and the conceptual data models have been updated and are now available.
08-03-2023
eAF-PMS FAQs Document Publication
The eAF and PMS teams are pleased to announce that an eAF-PMS FAQs Document is now available here. This document contains Frequently Asked Questions on eAF and PMS and will be updated regularly.
22-2-2023
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.6 released to production on 21st of February 2023 are now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
24-1-2022
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.4 released to production on 23rd January 2023 are now available on the PLM Portal Forum and on the PLM Portal eAF (DADI) web page.
And
Updated PLM Portal Guide to Navigation is now available
Please find an updated version of the PLM Portal eAF Guide to Navigation here.
And
eAF - PMS Newsletter Issue 2
We are pleased to inform you that the second edition of the eAF (DADI)-PMS Newsletter is published and available on the EMA corporate website here.
The eAF-PMS Newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities in the EU updates on the progress of the eAF and PMS products.
It also includes an overview of upcoming events and information on available resources.
For more insight on eAF, you are invited to register to the upcoming events and consult the following resources:
Training videos:
Useful resources:
Please share any questions with us at eSubProgofficer@ema.europa.eu.
31-10-2022
Updated Product Lifecycle Management Portal Guide to (DADI) eAF Registration is now available
An updated version of the PLM Portal (eAF) guide to registration is now available on PLM Portal eAF (DADI).
The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. Most of these steps are independent from the PLM Portal eAF and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems. Applicants are invited to register for the new PLM Portal with the support of this updated guide.
You will be able to sign into the portal after the go-live of the Human Variations electronic Application form (eAF) for CAPs.
For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.
Please share any questions with us via eSubProgofficer@ema.europa.eu.
14-10-2022
Web-based Human Variations eAF go-live details
EMA is pleased to inform that the web-based Human Variations electronic application form (eAF) for CAPs - often referred to by its former project name: DADI - will be available for use on 4 November 2022 on the new Product Lifecycle Management (PLM) Portal. EMA has been collaborating with the UNICOM consortium to develop the new web-form. To ensure full technical and business support services at go-live, release to the public is scheduled slightly later than the original target date of 31 October. This is due to European Holidays on November 1 and 2.
Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of scheduled improvements, improvements based on user acceptance testing (UAT) feedback or that may be identified by users after the release and new features, such as additional structured data fields. Going live as scheduled and continually improving the form is the most effective route to having a high performing web-form in the shortest timeframe and it is in accordance with an Agile way of working.
As a reminder: this release will not trigger a transition period towards mandatory use. The formal transition period will start after the anticipated March 2023 release when nationally authorised products (NAPs) features will be also added to the form. The interactive PDF eAF will remain available until the end of the transition period.
The new PLM Portal will in due course host all web based eAFs, data input user interface for product management service (PMS) data and the interface to provide data for electronic Product Information (ePI). You can expect reference to Digital Application Dataset Integration (DADI) to be phased out over the coming weeks in favour of eAF and the PLM Portal.
We have the following resources to help you get familiar with the new form and the new environment:
Pre go-live:
- Publication of the updated guides for portal registration and navigation (to be made available via the eSubmission website).
- Human Variations Form go-live Q&A session: 27 October 2022 (14:00-15:00), Registration link.
Post go-live:
- Human Variations web-based eAF Form training session: 8 November 2022 (10:00-11:30), Registration link.
- Q&A clinics:
Please note an updated general Q&A document, including Q&A’s on PMS, and a training Q&A document addressing questions raised during earlier eAF trainings are now available.
I have an urgent variations application, what should I do?
In case you are worried about speed, please feel free to use the old PDF form until further notice. Kindly note this the first release of the Human Variations Form: the intention is to expose it and allow people to use it on a voluntary basis for CAPs. Usage of the form is not yet mandatory. Only once we have fully transitioned Human Variation eAFs in 2023 will you be required to use the new web form.
How can I sign up for the next User Acceptance Tests (UAT)?
The development team will evaluate the UAT just completed and then decide the format for the UAT for the next release. Details on the timing of the UAT, the approach and how to express interest in joining will be shared in due course.
Kindly note that testing is not designed as a substitute for early access. This is exactly why the Human Variations Form is going live in November for CAPs only and for voluntary use.
Please share any questions with us at eSubProgofficer@ema.europa.eu
Updated Human variations Timeline and eAF Portal Guide to Registration now available
Please find the October 2022 version of the DADI Human Variations Forms timeline, outlining the updated go-live date and an update to the 2nd BETA UAT. The eAF Portal guide to registration has been updated. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform.
26-09-2022
Update of the DADI Q&A document
The DADI and PMS teams are pleased to announce that a joint DADI and PMS Q&A Document is now available here. Given their interdependencies, this updated version of Q&A document includes questions related to both DADI and PMS.
Human variations form updated timeline
Please find the September 2022 version of the DADI Human Variations Forms timeline, outlining the updated DADI BETA UAT timeframe. The UAT has started on 19th September and will end on the 30th September 2022.
02-08-2022
Questions and Answers document from the public webinar "DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live" held on 12th July 2022
The Q&A document from the public webinar is now available.
27-07-2022
The 1st DADI newsletter has been published on the EMA website
The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of the DADI project.
It also includes an overview of upcoming events and information on available resources.
You can find the first issue of the newsletter here.
14-07-2022
eAF Portal Guide to Registration v1 released
The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration.
The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).
For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.
Invitation to register to the DADI eAF training and Q&A webinars
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 in October 2022. To effectively support stakeholders ahead of the go-live date, EMA is pleased to announce two new public eAF training and Q&A webinars.
- 1st eAF training and Q&A webinar: 26 July 2022, 11:00-12:30 Central European Time (CET) - Registration link
- 2nd eAF training and Q&A webinar: 2 September 2022, 11:00-12:30 Central European Time (CET) - Registration link
These events are training webinars for industry and national competent authorities' stakeholders wishing to learn more about access management aspects related to the new eAF dedicated portal and the procedure to fill in a web-based eAF at go-live.
During the sessions, a demonstration focused on access management and the User Interface will be performed in order to showcase how to register and access the Portal, how to fill in the web-based eAF, select products and export the forms.
Kindly note recordings from both training sessions will be made available after each event.
Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.
07-07-2022
DADI Human Variations eAF User Acceptance Testing (UAT) - Call for Volunteers
In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the European Medicines Agency (EMA) is pleased to invite Applicants to participate in the User Acceptance Testing (UAT) phase of the Digital Application Dataset Integration (DADI) Network project.
UAT timeline and scope
The DADI UAT is planned to be conducted between 5 September and 16 September 2022. During that period, the production-like version of the electronic Application Forms (eAF) Portal will be open for testing. As recently communicated, please note that the scope of this UAT is limited to Centrally Authorised Products (CAPs). The UAT participants are expected to perform testing activities, by filling in electronic Application Forms as close as possible to real-life scenarios. Namely, this implies filling in an eAF for one or multiple CAPs, single scope or grouping of scopes from different variation procedure types (e.g., type IA or type II), and to export the PDF output to be included in a submission.
Information about training/troubleshooting material and sessions
If you would like to participate in the DADI UAT you are kindly asked to, as pre-requisites: (i) have an active EMA user account, and, (ii) request the necessary user access role(s), both via the EMA Account Management portal. A user guide will be provided.
Please note that prior to the DADI UAT, training/troubleshooting material and sessions will be provided to prepare the UAT participants to the maximum extent possible, thereby avoiding potential unnecessary problems that may occur during the UAT phase (e.g., registration process, access management, etc.).
A UAT kick-off session is planned for 5 September 2022.
The following two access management troubleshooting sessions are scheduled:
- First access management troubleshooting session: Thursday, 21 July 2022
- Second access management troubleshooting session: Tuesday, 23 August 2022.
The above-mentioned sessions aim to be a hands-on guide for testers to create an EMA user account and request user access role(s). Attendance to the sessions is optional: you may be interested in attending one out of the two access management troubleshooting sessions in case of issues with access management.
In addition, two public training and Q&A webinars are scheduled:
- First training and Q&A webinar: Tuesday, 26 July 2022
- Second training and Q&A webinar: Friday, 2 September 2022.
The EMA will make available the training materials and provide more details on how to attend the scheduled sessions in due course.
Information about reporting findings/bugs
Only consolidated feedback is expected to be reported to the EMA by a limited number of users (coordinators), who will be granted access to Azure DevOps, the EMA’s platform for bug reporting purposes.
You are kindly requested to report your bugs/findings directly to your Industry Association. The following Industry Associations have been shortlisted to collect your feedback:
- AESGP
- EFPIA
- Europharm
- EuropaBio
- Medicines for Europe
- Vaccines Europe
Please directly contact your respective Industry Association to liaise on the practicalities for reporting a bug/finding. Please note that the number of participants to the UAT is limited.
If you are not a member of an Industry Association, i.e., for example, you represent a consultancy, please check with the company you represent if they can grant you access in IAM and if you can report the findings through the Industry Association they belong to.
Next steps
Please inform the EMA at your earliest convenience, whether you would like to participate in the DADI UAT to test the eAF platform.
We look forward to receiving your feedback, by writing to eAF-testing@ema.europa.eu (cc: industry@ema.europa.eu) at the latest by 15th July 2022, with the following information (for each organisation):
- First name, last name, and e-mail address of members interested in participating to the UAT
- Name of your organisation and, if already available, OMS Location ID
- Name of the Industry Association to which you aim to report findings/bugs (if/when applicable)
After the call for interest deadline you will receive a communication informing you if you have been selected to participate to the UAT.
For further information please see a presentation including the DADI UAT timeline.
05-07-2022
DADI Project Human Variations revised go-live scope
EMA will launch the eAF variations web form in October 2022. This is a first release of the web-based variation form for human medicinal products that will be improved and expanded in subsequent releases in 2023. This progressive release model follows the Agile development model of the Agency.
The scope of the October 2022 go-live will be limited to Centrally Authorised Products (CAPs). EMA made this decision due to the complexity in synchronisation of the data between xEVMPD and PMS. At this initial release of the form the available data for CAPs is coming from EMA internal database and it is the same dataset currently used in IRIS to support Inspections.
This version of the form cannot yet be used for applications containing Nationally Authorised Products (NAPs), including National Procedures, Mutual Recognition Procedure and Decentralised Procedure.
A subsequent release of the form in March 2023 will support all types of EU variation procedures (CAPs and NAPs).
The timeline describing updated release schedule reflecting the revised dates for subsequent releases is available here.
We appreciate you may have questions about this change of scope. To help address these we are offering:
- A Q&A webinar on 12 July, 11:00-12:30 Central European Time (CET) (Please use this Registration link to register to join this Q&A session).
- An update to chapter 7 of the EU Implementation Guide for ISO IDMP covering details of what a CAPs only go-live will mean which will be published soon.
- A DADI Q&A document around what will happen at go-live which will be published before end of July 2022.
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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