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

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 1st 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: info@asphalion.com

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