DADI webinar: Are you ready for Go-Live?

DADI will finally go live on November 4, 2022!

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 November 2022

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 November 2022
October 17, 2022

The web-based eAF will be available on the new Product Lifecycle Management (PLM) portal that will host:

  • eAFs
  • The data input user interface for Product Management Service (PMS) data
  • The interface to provide data for electronic Product Information (ePI)

Some highlights on this release:

  • It will not trigger a transition period towards mandatory use.
  • The transition period will start after the March 2023 release, once nationally authorised products (NAPs) features are added to the form.
  • The current PDF eAF will remain available until the transition period finishes.

Upcoming events for DADI key-users:

  • Pre go-live:
    • Publication of the updated guides for portal registration and navigation
    • Human Variations Form go-live Q&A session: 27 October 2022 (14:00-15:00)
  • Post go-live:
    • Human Variations web-based eAF training session: 8 November 2022 (10:00-11:30)
    • Q&A clinics: 15, 22 and 29 November 2022 (11:00-11:30)

Stay tuned for additional updates!

For further information, do not hesitate to contact us at: info@asphalion.com

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EVENT | EMA PMS Info Day

EMA is holding a new public event with the purpose to provide a comprehensive understanding of Product Management Service (PMS) and its implications on other EMA digital services with the objective to introduce the core concepts of PMS, ensuring that all attendees have the chance to understand its implementation.

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