Safety & Vigilance
Quality & Compliance
13 may 2022
It is increasingly important to have a robust Regulatory Information Management System (RIMS) in place to support the regulatory process through the streamlining of registration, data, and lifecycle management. As a first step towards the implementation of a RIMS, the European Medicines Agency’s Digital Application Dataset Integration (DADI) will replace the current PDF-based electronic forms (eAF) with a new web-based application to harmonize data management.
DADI will enhance the way dossiers are submitted to the health authority by increasing efficiency and reducing errors and discrepancies. It will help with the planning and tracking of information, allowing for the full use of existing product management services master data. With an expected October 2022 launch for human medicinal products, there will be a 6-month transition period where organizations will still be able to submit using eAF or using the new web-based application. The service will become available for centrally authorized products and nationally authorized products later in 2022, or early 2023.
During this digital transformation, it is important that pharmaceutical companies are aware of all the necessary changes taking place. Many pharmaceutical companies are investing in a professional RIMS to support and strengthen their processes. ProductLife Group (PLG) have outstanding RIMS consultants who are on hand to help clients to better manage their regulatory information. Our teams can help navigate the changes and provide IT solutions to optimize the use of DADI. Contact us to find out more.
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