Announcement of Trainings and Q&A Sessions on web-based Human variations electronic Application Forms (eAFs) for CAPs and non-CAPs
Following the launch of optional use in February 2025, EMA now recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible. To provide support during this transition, EMA will host two dedicated training sessions and two Q&A sessions.
date: [29/08/2025]
Following the launch of optional use in February 2025, EMA now recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible. This is aligned with the timeline and the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations.
Please note that the interactive PDF eAF remains available for use for all variation procedures and while the PLM Portal eAF is now recommended for use for all procedure types, there are some technical limitations, and in these cases you might need to use the interactive pdf forms. Consult the guidance and the release notes.
To provide support during this transition, EMA will host two dedicated training sessions and two Q&A sessions.
1.Training session on human variations web-based electronic Application Form (eAF) for non-CAPs:
📅 Date: Wednesday, 10 September 2025
🕐 Time: 10:00 – 11:30 CEST
📍 Registration: Register at the event webpage here
2.Training session on human variations web-based electronic application form (eAF) for CAPs:
📅 Date: Monday, 15 September 2025
🕐 Time: 10:00 – 11:30 CEST
📍 Registration: Register at the event webpage here
3.Q&A clinic on web-based eAF functionalities for CAPs and non-CAPs:
📅 Date: Tuesday, 30 September 2025
🕐 Time: 15:00 – 16:00 CEST
📍 Registration: Register at the event webpage here
4.Q&A clinic on web-based eAF functionalities for CAPs and non-CAPs:
📅 Date: Thursday, 09 October 2025
🕐 Time: 11:00 – 12:00 CEST
📍 Registration: Register at the event webpage here
The video recordings are made available after the events.