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

• Date:
  Monday, 16 May 2022 , 10:00 - 12:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

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

Documents

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

Reference Number: EMA/226955/2022

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

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

Digital application dataset integration (DADI) human variations form timeline

Variation fast healthcare interoperability resources (FHIR) mapping & examples