FORUM INSTITUT SEMINAR | Updates on EMA Electronic Application Management

The variations submission for human medicines became the first form to be submitted via the PLM portal in November 2022, with other application forms to follow.

The variations submission for human medicines became the first form to be submitted via the PLM portal in November 2022, with other application forms to follow.
March 13, 2023

📆 26 April, 2023       💻 Online course

The Product Lifecycle Management (PLM) portal, which will replace electronic application forms (eAFs) in PDF format for regulatory applications, is intended to make filling in forms and processing applications more efficient in the future.

ASPHALION experts Laura Casals, Lourdes Martín and Núria García Pazos, together with other two excellent lecturers will bring you up to date with the electronic submission form on the PLM portal and prepare you for future developments.

The online training course organized by FORUM INSTITUT will cover the following topics:

·        Introduction to ISO IDMP and implementation process

·        PMS rationale and implementation

·        Product Lifecycle Management (PLM) portal

·        Effects of IDMP implementation on the regulatory processes

·        Introduction to CTIS portal management and main functionalities

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