Purpose and context
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EMA EudraVigilance Registration Manual (QPPV registration) - Document
Training videos
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PLM portal - Intro and sign in - YouTube
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How to start using the system - previously created forms - YouTube
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How to "Create a new application" section on the PLM portal - eAF - YouTube
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How to "Select Reference MAH" section on the PLM portal - eAF - YouTube
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How to "Add a Co-author" section on the PLM portal - eAF - YouTube
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How to fill in "Product selection" section on the PLM portal - eAF - YouTube
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How to fill in "Added products - Popup window" section on the PLM portal - eAF - YouTube
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How to fill in "Product selection, MRP Number assignment" section on the PLM portal - eAF - YouTube
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How to fill in "Types of changes" section on the PLM portal - eAF - YouTube
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How to fill in "Procedural information" section on the PLM portal - eAF - YouTube
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How to fill in "Proposed changes" section on the PLM portal - eAF - YouTube
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How to fill in "Additional information" section on the PLM portal - eAF - YouTube
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How to fill in the "Finalisation" section on the PLM portal - eAF - YouTube
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How to fill in the "Exported PDF and Integrity stamp" section on the PLM portal - eAF - YouTube
Please note that the web-based electronic application form (eAF) is subject to ongoing maintenance and enhancements. As the application evolves, some elements shown in the video demonstrations may differ slightly from the current version of the application. We will update the videos periodically to reflect these updates
2 eAF Frequently Asked Questions (FAQs) document
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eAF Q&A document - Document (last updated in Dec 2025)
3 Training sessions
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15 Sep 2025 - eAF training on web-based electronic application form functionalities for CAPs - YouTube
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10 Sep 2025 - eAF training on web-based electronic application form functionalities for non-CAPs - YouTube
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8 Jul 2025 - Q&A clinic on web-based electronic Application Form (eAF) functionalities - YouTube
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1 Jul 2025 - training session on Human variations web-based electronic Application Form (eAF) for non-CAPs - YouTube
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13 Mar 2025 - Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations - YouTube
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06 Mar 2025 - Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations - YouTube
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27 Feb 2025 - training on human variations web-based electronic application form (eAF) functionalities for CAPs and non-CAPs variations - YouTube
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11 Feb 2025 - training on human variations web-based electronic application form (eAF) functionalities for non-CAPs variations - YouTube
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14 Nov 2024 - Q&A clinic on Human variations web-based eAF - YouTube
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08 Nov 2024 - Human variation eAF training session and Q&A clinic - YouTube
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25 Oct 2024 - Q&A clinic Human variations web-based electronic Application Form (eAF) for non-CAPs - YouTube
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17 Oct 2024 - training session on non-CAPs in web-based eAF - YouTube
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18 Jul 2024 - info session on eAF add package - YouTube (One existing pack size) - YouTube (Multiple existing pack sizes)
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7 May 2024 - information and Q&A session on updated CAPs in web-based eAF - YouTube
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8 Nov 2022 - eAF post go-live public training session - Human variations eAF (DADI) training session - YouTube
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2 Sep 2022 - eAF public training session - 2nd DADI eAF training webinar - YouTube
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26 Jul 2022 - eAF public training session – 1st DADI eAF training webinar - YouTube
4 Webinars
2023
Update on Human variations web-based eAF implementation on PLM portal (6 Nov 2023)
This is a joint eAF-PMS webinar intended for business and technical audiences interested in the use of Human variations web-based eAFs
Human variations web-based eAF training session (2 Feb 2023)
This event is a training webinar for industry and national competent authorities’ stakeholders wishing to learn more about the use of the new PLM portal and web forms features after the go-live.
2022
Human Variations web-based eAF Form training session (15 Dec 2022)
Human Variations web-based eAF Form training session (8 Nov 2022)
This event is a training webinar for industry and national competent authorities’ stakeholders wishing to learn more about the use of the new PLM portal and web forms features after the go-live.
Human Variations Form go-live Q&A session (27 Oct 2022)
This event is a Q&A webinar aiming at addressing questions from industry and national competent authorities’ stakeholders concerning the release of the web-based variations eAF for Human CAPs.
eAF Q&A clinic recordings
These Q&A Clinic sessions aim at addressing questions from users of PLM portal and web forms users after the release of the electronic application forms (eAF)
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Human variation eAF Q&A clinic - session 7 (22 Jan 2023)
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Human variation eAF Q&A clinic - session 6 (17 Jan 2023)
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Human variation eAF Q&A clinic - session 5 (19 Dec 2022)
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Human variation eAF Q&A clinic - session 4 (14 Dec 2022)
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Human variation eAF Q&A clinic - session 3 (access management) (29 Nov 2022)
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Human variation eAF Q&A clinic - session 2 (22 Nov 2022)
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Human variation eAF Q&A clinic - session 1 (15 Nov 2022)
DADI PDF electronic application forms eAF training webinar (2 Sep 2022)
This event is a training webinar for industry and national competent authorities’ stakeholders wishing to learn more about access management aspects related to the new dedicated portal and the procedure to fill in a web-based eAF at go-live.
DADI PDF electronic application forms (eAF) training webinar (26 July 2022)
This event is a training webinar for industry and national competent authorities’ stakeholders wishing to learn more about access management aspects related to the new dedicated portal and the procedure to fill in a web-based eAF at go-live.
DADI Q&A webinar "Variations form for Human medicinal products go-live" (12 Jul 2022)
This event is a dedicated Q&A webinar for business and technical audiences from industry and national competent authorities to address questions about the revised scope of the DADI October go-live.
DADI-PMS webinar “Variations form for human medicinal products - What will happen at go-live” (16 May 2022)
This event is a joint DADI-PMS webinar 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.
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DADI-PMS What will happen at go-live Q&A (Jun 2022)
Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms (18 Jan 2022)
This webinar is for stakeholders from the human & veterinary medicines industry and national competent authorities wishing to learn more about DADI roadmap & objectives for CAPS & NAPS, DADI’s connection to EMA’s Regulatory Business Optimisation, and main changes introduced by DADI and impacts for the pharmaceutical industry.
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 Jan 2022)
This webinar is for technical experts from industry and national competent authorities wishing to learn more about the design of the FHIR message for the first form to be updated: Human variations.
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Variation FHIR mapping and examples (Draft version from Jan 2022)