Digital application dataset integration (DADI) webinar - common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic application forms (eAF)

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 second public webinar is for technical experts from industry and national competent authorities wishing to learn more about the design of the FHIR message for the first form to be updated: Human Variations.

Despite the focus on human medicines, all stakeholders interested in the technical aspects of the FHIR message are welcome.

Topics addressed in this webinar include the:

• FHIR data standard and its use in electronic application
• conceptual model of the FHIR message for human medicines’ variations forms
• PMS data model and how it links to DADI