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.
March 13, 2023
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.
Regulatory Information Management (RIM) system is a vital element of any regulatory strategy, since it allows processes and data governance optimization. RIMs are becoming even more essential with the upcoming ISO IDMP implementation, as it offers “directed” solutions to comply with the standards and regulations.
Join Asphalion experts Beatriz Ugalde, Lourdes Martín and Helena Catena who will deliver this webinar about the
At Asphalion we are always up to date with the latest digital developments! This is why our
At Asphalion we are happy to announce that Silvia Santos is now Associate Director!! Silvia has a Pharmacy Degree and extensive
La Agencia Europea del Medicamento (EMA) ha comenzado la implementación de los estándares desarrollados por la Organización Internacional de Normalización (ISO, del inglés International Organization for Standardization) para la identificación única de medicamentos (IDMP, del inglés Identification of Medicinal Products).
Asphalion has been featured as one of the 10 Best Healthcare Solution Companies in 2022.
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.
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