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

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.