2nd eAF (DADI) Newsletter has been published on the EMA website!

2nd eAF (DADI) Newsletter has been published on the EMA website: The web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) - often referred to by its former project name, DADI – has been available for use as of 4 November 2022 on the new Product Lifecycle Management (PLM) Portal.

2nd eAF (DADI) Newsletter has been published on the EMA website: The web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) - often referred to by its former project name, DADI – has been available for use as of 4 November 2022 on the new Product Lifecycle Management (PLM) Portal.

December 22, 2022

| Data Management, EU, Regulatory Operations: eCTD and Submissions

The eAF (DADI) newsletter is published four times a year and provides pharmaceutical companies and the national competent authorities in the EU with updates on the progress of the eAF (DADI) project.

This second issue covers topics such as:

Web-based Human Variations eAF: Training material, Release Notes and Q&A Documents
Reschedule of UAT and releases of eAF during 2023
PMS: SMEs nomination and Priorities for Q4 2022

You can find the complete second issue of the newsletter here.

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2nd eAF (DADI) Newsletter has been published on the EMA website!

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2nd eAF (DADI) Newsletter has been published on the EMA website!

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