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News

Previous DADI news can be found here

 

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: 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 2023Start 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 2023Expected 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 2024Confirmation of transition period start date, approximately 2 months in
Q2 2024Start 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:
  • eAF-PMS FAQs Document (link), including Q&A's on PMS (Product Management Services);
  • 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.

PLM Portal eAF (DADI) documentation: PLM Portal eAF webinars:
  • Human Variations web-based eAF Form training session (2 February 2023)
  • Human Variations web-based eAF Form training session (15 December 2022)
  • Human Variations web-based eAF Form training session (8 November 2022)
  • Human Variations Form go-live Q&A session (27 October 2022)
  • eAF Q&A clinic recordings:
  • Human Variation eAF Q&A Clinic - session 7 (22 January 2023)
  • Human Variation eAF Q&A Clinic - session 6 (17 January 2023)
  • Human Variation eAF Q&A Clinic - session 5 (19 December 2022)
  • Human Variation eAF Q&A Clinic - session 4 (14 December 2022)
  • Human Variation eAF Q&A Clinic - session 3 (access management) (29 November 2022)
  • Human Variation eAF Q&A Clinic - session 2 (22 November 2022)
  • Human Variation eAF Q&A Clinic - session 1 (15 November 2022)
  • DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live - (12 July 2022)
  • Quarterly system demo (including DADI) - (28 June 2022)
  • DADI-PMS Webinar “Variations form for human medicinal products - What will happen at go-live” (16 May 2022)
  • Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms (18 January 2022)
  • Digital application dataset integration (DADI) - common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic application forms (eAF) (25 January 2022)

 

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