2024-12-21 2024-12-21 , 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
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.
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.

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 10032

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Termin

26/03/-04/06/2025

26/03/-04/06/2025

Zeitraum

e-learning start: 26 March 2025
live-online-seminars: 9 April 2025, 8 and 9 May 2025, 4 June 2025

e-learning start: 26 March 2025
live-online-seminars: 9 April 2025, 8 and 9 May 2025, 4 June 2025
Veranstaltungsort

online

online

Downloads
Training Overview
Training Overview
Gebühr

Veranstaltung - 3,690 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.

Veranstaltung - 3,690 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.

Jetzt buchen

Your contact

Dr. Rebekka Bitsch
Conference Manager

+49 6221 500-565
r.bitsch@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

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.

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.

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 26 March 2025, 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 9 April 2025, "Marketing Authorisation Documents in the EU" on 8 and 9 May 2025, as well as "Regulatory Lifecycle Management" on 4 June 2025, can be also accessed via your customer portal.

Your benefits

  • 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
  • Specific information on data exclusivity, innovation protection and requirements for generics
  • Detailed knowledge of the CTD structure and specifications for Modules 1-5
  • Key elements and structure of the SmPC and package leaflet
  • Practical insights into compiling nonclinical and clinical data
  • An understanding of eCTD principles, document requirements and submission
  • Strategies to avoid common errors and align with authority expectations
  • All post-approval activities covered
  • Interactions between the PV, regulatory affairs and labelling departments throughout the lifecycle

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

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 live-online-seminars

Regulatory Lifecycle Management

This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submi...

04.06.2025, online
Details

Marketing Authorisation Documents in the EU

This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission proce...

08. - 09.05.2025, online
Details

Marketing Authorisation Procedures in the EU

This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, app...

09.04.2025, online
Details

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...

Details
e-Learning
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...

Details
e-Learning