DADI webinar - Introducing DADI: The digital application dataset integration network project to replace electronic application forms, Online, 10:30 -

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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 first public webinar is for Human & Veterinary Medicines Industry and National Competent Authorities’ (NCA) stakeholders that wish to learn more about:

  • 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

Sumber : https://www.ema.europa.eu
 
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