Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics - Session 1
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).
This short Q&A session aims at addressing 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 between the end of Q2 2023 and beginning of Q3 2023.
A video recording will be made available after the event.
Participants can ask questions in advance of the event start date, and during the event via the audience interaction tool Slido.
Please go to www.sli.do and enter the event code #9710695
Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to process your personal data as explained in the EMA Data Privacy Statement for Slido.