08/04 - 10/06/2026
08/04 - 10/06/2026
e-learning start: 8 April 2026
live-online-seminars: 22 April 2026, 5-6 May 2026, 10 June 2026
online
online
Veranstaltung - 3,690 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including a PreMeeting.
OPTIONS
Marketing Authorisation Procedures in the EU
+0,00 €
Marketing Authorisation Documents in the EU
+0,00 €
Regulatory Lifecycle Management
+0,00 €
Veranstaltung - 3,690 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including a PreMeeting.
OPTIONS
Marketing Authorisation Procedures in the EU
+0,00 €
Marketing Authorisation Documents in the EU
+0,00 €
Regulatory Lifecycle Management
+0,00 €
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
Participants in this qualification course will receive thorough training on the main regulatory duties, from marketing authorisation applications to lifecycle management. This is the ideal preparation for starting a career in drug regulatory affairs. After course completion a certificate will be awarded.
This qualification course provides an in-depth exploration of EU drug regulatory affairs. With two e-learnings for self-study and three live online seminars led by regulatory affairs experts, participants will acquire comprehensive knowledge and practical strategies for successful marketing authorisation applications and lifecycle management in the EU.
The two e-learnings cover the basics of marketing authorisation in the EU and the variations system, allowing participants to build a solid foundation through self-study.
Three live online seminars cover the topics of marketing authorisation procedures, the common technical document (CTD), and lifecycle management. Regulatory affairs experts provide practical knowledge, essential insights, and strategies for regulatory affairs management in the EU. Examples and case studies, as well as time for questions, are included.
Once you have registered for this course, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses.
Starting on 8 April 2026, you will have access to the two e-learnings "Introduction to EU Marketing Authorisation" and "EU Variation System and Procedures". You can start your e-learning in the customer portal by clicking "Participate" directly in the respective e-learning. You will then be redirected to the learning platform.
The live-online-seminars "Marketing Authorisation Procedures in the EU" on 22 April 2026, "Marketing Authorisation Documents in the EU" on 5-6 May 2026, as well as "Regulatory Lifecycle Management" on 10 June 2026, can be also accessed via your customer portal.
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