Webcode 25112610
Gabriele Eibenstein M.A.
-requested- Senior Expert in Regulatory Affairs, Bonn, GERMANY
Senior Expert in Regulatory Affairs Ms Eibenstein has extensive expertise in European procedural management, heads the specialist field "RAS, AM counterfeiting, supply shortages" at BfArM, is the German member of the SPOC Working Party, and is actively involved in shortage management at both national and European levels.
Dr. Christian M. Moers
Sträter Lawyers, Bonn, GERMANY
Lawyer;
His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows:
- European and German medicinal product law
- Marketing authorisation law & regulatory affairs
- Pharmacovigilance
- Wholesale trade with medicinal products, distribution of medicinal products
- Manufacture of medicinal products
More information please click here.
25/11/2025
25/11/2025
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 seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and centralised procedures (MRP, DCP, CP) in detail, providing essential insights for successful EU drug approval.
This seminar provides a comprehensive understanding of EU drug marketing authorisation procedures.
Participants will explore the regulatory framework, various application types, and detailed application procedures, gaining essential insights into navigating EU drug approval complexities.
Welcoming and introduction round
Dr Christian M. Moers
Coffee break
Dr Christian M. Moers
Lunch break
Gabriele Eibenstein M.A.
Coffee break
Gabriele Eibenstein M.A.
Questions and answers
End of the seminar
Do you lack basic marketing authorisation expertise? Then, we would recommend the e-Learning 'Introduction to EU Marketing Authorisation' e-learning.
This will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.
Upon completion, you will be conversant with the key principles of regulatory affairs and have a good starting basis to work in this field.
Please register for the seminar "Marketing Authorisation Procedures in the EU" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning (you will be billed €290 + local VAT rather than €390 + local VAT).
Once you have registered for an event, 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. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
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.
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