Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live
Table of contents
The Digital Application Dataset Integration (DADI) project will replace PDF electronic application forms (eAF) used for regulatory submissions with online 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.
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. 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 variation form;
- Data in the form coming from PMS;
- The process after the approval of the variation;
- Electronic submission requirement to the Extended EudraVigilance Medicinal Product Dictionary (xEVMPD).
Video recording will be available after the webinar.
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Agenda - Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live (PDF/177 KB)
First published: 02/05/2022
Last updated: 11/05/2022
EMA/226955/2022 -
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Presentation - Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live (PDF/1.24 MB)
First published: 16/05/2022 -
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Questions and answers - Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live (PDF/472.09 KB)
First published: 15/07/2022 -
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Digital application dataset integration (DADI) human variations form timeline (PDF/113.42 KB)
First published: 25/05/2022 -
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Variation fast healthcare interoperability resources (FHIR) mapping & examples (ZIP/6.51 MB)
First published: 07/03/2022
Last updated: 31/05/2022