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EMA Events
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The web-based electronic application forms (eAF) will replace PDF eAFs used for regulatory submissions in the new Product Lifecycle Management (PLM) portal. This is a first step towards making the form-filling and submission-handling process more efficient.
The web-based variations form for Human medicinal centrally authorised products (CAPs) was released on 4 November 2022. Subsequently, the form will support all types of EU variation procedures (CAPs and NAPs).
This event is a training webinar for industry stakeholders with NAPs and CAPs and National Competent Authorities wishing to learn more about access management aspects related to the new PLM portal.
A video recording will be made available after the event.
Registration is open at the following link.
Sumber : https://www.ema.europa.eu
The web-based variations form for Human medicinal centrally authorised products (CAPs) was released on 4 November 2022. Subsequently, the form will support all types of EU variation procedures (CAPs and NAPs).
This event is a training webinar for industry stakeholders with NAPs and CAPs and National Competent Authorities wishing to learn more about access management aspects related to the new PLM portal.
A video recording will be made available after the event.
Registration is open at the following link.
Sumber : https://www.ema.europa.eu