Maintenance and sustainment of human medicinal product approvals
Webcode 26062610
10/06/2026
10/06/2026
from 09:00 - 17:00
You may dial-in 30 minutes before
online
online
Event - 1,290€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 1,290€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes. It will also cover all important aspects of the revised variation framework (new Regulation and updated Guideline).
This seminar provides a comprehensive overview of all maintenance activities in the lifecycle of a medicinal product. All relevant updates introduced by the Commission Delegated Regulation (EU) 2024/1701 will be covered as well as important changes introduced by the new Variation Guideline (applicable since 15.01.2026).
Participants will receive thorough training on the main regulatory duties, from dossier update and variations to PV activities, through to labelling maintenance duties. All in a single seminar.
Time and deadline management, as well as internal company interactions and coordination will be covered, which makes the seminar interesting for professionals from the various departments involved in the product lifecycle.
