2025-09-30 2025-09-30 , online online, 3,690 € zzgl. MwSt. Qualification Course: EU Regulatory Affairs Manager

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.

Topics
  • Regulatory frameworks, application types, and procedures
  • Mutual recognition, decentralised, and centralised procedures (MRP, DCP, CP) in detail
  • Marketing authorisation dossier and the electronic submission process
  • CTD structure and modules 1-5 in detail
  • Regulatory lifecycle management, variation submission, PV activities, and labelling changes


Who should attend
This qualification course is specifically tailored for beginners and career changers who wish to start a career in EU drug regulatory affairs.

Junior regulatory affairs managers who need in-depth knowledge about the main regulatory duties, from marketing authorisation applications to lifecycle management, will also benefit from the course.
Aims and objectives
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.
Your benefit

  • In-depth knowledge of EU regulatory framework and marketing authorisation procedures
  • Insights into the roles and functions of relevant authorities and committees
  • Strategies for mutual recognition and decentralised procedures
  • Detailed understanding of the centralised procedure and scientific advice process
  • Detailed knowledge of the CTD/eCTD structure and specifications for Modules 1-5
  • Key elements and structure of the SmPC and package leaflet
  • All post-approval activities covered
  • Interactions between the PV, regulatory affairs and labelling departments throughout the lifecycle

Qualification Course: EU Regulatory Affairs Manager

Qualification Course: EU Regulatory Affairs Manager

Benefits
  • Solid foundation in EU drug regulatory affairs
  • Combination of e-learning and live online training
  • 25 % savings compared to individual bookings
  • Certified to ISO 9001 and ISO 21001 standard

Webcode 60012601

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Alles auf einen Blick

Termin

08/04 - 10/06/2026

08/04 - 10/06/2026

Zeitraum

e-learning start: 8 April 2026
live-online-seminars: 22 April 2026, 5-6 May 2026, 10 June 2026

e-learning start: 8 April 2026
live-online-seminars: 22 April 2026, 5-6 May 2026, 10 June 2026
Veranstaltungsort

online

online

Downloads
Brochure
Brochure
Gebühr

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 €

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Jean-Marie Bayhurst
Conference Manager

+49 6221 500-685
j.bayhurst@forum-institut.de

Details

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.

Topics

  • Regulatory frameworks, application types, and procedures
  • Mutual recognition, decentralised, and centralised procedures (MRP, DCP, CP) in detail
  • Marketing authorisation dossier and the electronic submission process
  • CTD structure and modules 1-5 in detail
  • Regulatory lifecycle management, variation submission, PV activities, and labelling changes


Who should attend
This qualification course is specifically tailored for beginners and career changers who wish to start a career in EU drug regulatory affairs.

Junior regulatory affairs managers who need in-depth knowledge about the main regulatory duties, from marketing authorisation applications to lifecycle management, will also benefit from the course.

Aims and objectives

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.

Your benefit

  • In-depth knowledge of EU regulatory framework and marketing authorisation procedures
  • Insights into the roles and functions of relevant authorities and committees
  • Strategies for mutual recognition and decentralised procedures
  • Detailed understanding of the centralised procedure and scientific advice process
  • Detailed knowledge of the CTD/eCTD structure and specifications for Modules 1-5
  • Key elements and structure of the SmPC and package leaflet
  • All post-approval activities covered
  • Interactions between the PV, regulatory affairs and labelling departments throughout the lifecycle

More information

Access and procedure

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.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

Your e-learnings for self-study

e-Learning: Introduction to EU Marketing Authorisation

This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketi...

jederzeit
Details

e-Learning: EU Variation System and Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of var...

jederzeit
Details

Your live-online-seminars

Marketing Authorisation Procedures in the EU

22.04.2026

Details
Learning Space
Marketing Authorisation Documents in the EU

05. - 06.05.2026

Details
Learning Space
Regulatory Lifecycle Management

10.06.2026

Details
Learning Space