May 16, 2022 · The Digital Application Dataset Integration (DADI) project will replace PDF electronic application forms (eAF) used for regulatory submissions with online forms, making …

EMA is pleased to inform that the web-based Human Variations electronic application form (eAF) for CAPs - often referred to by its former project name: DADI - will be available for use on 4 …

Testing started in November 2021 and is performed by EMA staff and a selection of volunteers from the DADI SME Group. The SME Group comprises Subject Matter Experts from EMA, …

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

DADI is a Network project led by the European Medicines Agency (EMA) which will support both centrally authorised product (CAP) applications and nationally authorised product (NAP) …

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

• IRIS is EMA’s online platform to support product-related scientific and regulatory procedures with EMA. • The future DADI portal will facilitate the population of complex forms with standard …

Jan 18, 2022 · The Digital Application Dataset Integration (DADI) project will replace PDF electronic application forms (eAF) used for regulatory submissions with online forms, making …

Mar 24, 2022 · EMA decided to build on the “momentum, relevant expertise and know-how” that was accumulated during the CESSP Phase 1 project and started another project: DADI. …

DADI and PMS are key enablers for the implementation of more digital and improved core regulatory procedure management as part of EMA and the Network’s digital transformation.