Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live

Date: 16/05/2022
Location: Online, 10:00 - 12:00 Amsterdam time (CEST)

Event summary

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.

Video recording


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