The web-based Human Variations eAF goes live today!

The web-based electronic application forms (eAF) will replace PDF eAFs used for regulatory submissions in the new dedicated PLM portal. This is a first step towards making the form-filling and submission-handling process more efficient.

The web-based electronic application forms (eAF) will replace PDF eAFs used for regulatory submissions in the new dedicated PLM portal. This is a first step towards making the form-filling and submission-handling process more efficient.

November 4, 2022

| Data Management, Regulatory Operations: eCTD and Submissions

The web-based Human Variations eAF (formerly known as DADI) is now available for use on the new Product Lifecycle Management (PLM) portal.

Some key points:

This 1^st release only supports CAPs
The interactive PDF eAF will remain available until the end of the transition period.
The PLM Portal (eAF) guide to registration has been updated to support users regarding the registration steps to access the platform
The existing bugs will be published for users awareness
The fixes to the bugs will be released on a regular basis

As a reminder: the xEVMPD process is not changing for the moment!

Upcoming EMA webinars on the web-based Human Variations eAF:

Human Variations web-based eAF training session: 8 November 2022 (10:00-11:30)
Q&A clinics: 15 November 2022 (11:00-11:30)

For further information, contact us at: [email protected]

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The web-based Human Variations eAF goes live today!

The web-based electronic application forms (eAF) will replace PDF eAFs used for regulatory submissions in the new dedicated PLM portal. This is a first step towards making the form-filling and submission-handling process more efficient.

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