Posted Tue, 09 May 2023 08:46:57 GMT by Caterina Scarpati

EMA is pleased to announce a new public 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.

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).

The event will take place on 25 May 2023, h.11.00 - 12.30 Central European Summer Time (CEST).

Registration is open at the following link.
Registration will stay open until the start of the session.

Posted Wed, 24 May 2023 12:23:48 GMT by Henry Quinn
Hi Caterina,

Will a recording of this Webinar be made available?

Kind Regards
Posted Wed, 24 May 2023 12:35:35 GMT by Caterina Scarpati

Good afternoon Henry,

I confirm the webinar will be recorded.

The recording will be published on the event web page and EMA YouTube Channel.

Kind regards,