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The DADI project will replace current PDF format electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. DADI is a Network project of EU regulators which addresses eAFs for both Centrally Authorised Products (CAPs) as well as 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 NCAs that wish to learn more about the design of the FHIR message for the first form to be updated: Human Variations. Despite the focus on Human at the time – any stakeholders interested in the technical aspects of the FHIR message are welcome.
Topics that will be addressed in this webinar:
Sumber : https://www.ema.europa.eu
This second public webinar is for technical experts from Industry and NCAs that wish to learn more about the design of the FHIR message for the first form to be updated: Human Variations. Despite the focus on Human at the time – any stakeholders interested in the technical aspects of the FHIR message are welcome.
Topics that will be addressed in this webinar:
- The FHIR data standard and its use in electronic application
- The conceptual model of the FHIR message for human medicines’ variations forms
- The PMS data model and how it links to DADI
Sumber : https://www.ema.europa.eu