Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms

• Date:
  Tuesday, 18 January 2022 , 10:30 - 12:00 Amsterdam time (CET)
• 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.

DADI is a European medicines regulatory network project that addresses eAFs for both centrally authorised products (CAPs) and nationally authorised products (NAPs). The new web-based forms will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard.

The implementation of these new forms supports the EU requirement to integrate ISO IDMP (Identification of Medicinal Products) standards for human medicines.

This first public webinar is for stakeholders from the human & veterinary medicines industry and national competent authorities wishing to learn more about the following:

• DADI roadmap & objectives for CAPS & NAPS
• DADI’s connection to EMA’s Regulatory Business Optimisation
• Main changes introduced by DADI and impacts for the pharmaceutical industry

A video recording will be made available after the event.

Documents

Agenda - DADI webinar - Introducing DADI: The digital application dataset integration network project to replace electronic application forms

Adopted Reference Number: EMA/729279/2021

Presentation - Introducing DADI: The digital application dataset integration network project to replace electronic application forms

Video recording