EMA has organised two short Q&A clinics to address questions from business and technical audiences working for industry and national competent authorities that are interested in the use of eAFs for NAPs following the PMS data release in the PLM Portal that will happen in 2023.
Please find below the details on the sessions:
- 15 June 2023 (15:00 – 15:30 Central European Summer Time (CEST)): register here
- 22 June 2023 (15:00 – 15:30 CEST): register here
The web-based electronic application forms (eAF) in the new Product Lifecycle Management (PLM) portal will replace the current interactive PDF eAFs used for regulatory submissions. 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. Following the Product Management Service (PMS) data release, the form will support all types of EU variation procedures, CAPs and Nationally Authorised Products (NAPs).
Participants can ask questions in advance of the event, and during the event via the audience interaction tool Slido.
Please go to www.sli.do and enter the event code:
- #9710695 (15 June)
- #2269213 (22 June)
