Requirements, Timelines and Transition Strategies
Webcode 26102640
Karl-Heinz Loebel
PharmaLex GmbH, Mannheim
Director, Principal Consultant Regulatory Operations
After completing his studies, K.H. Loebel worked at Heidelberg University for several years before joining a biotechnology start-up company in 2000. K.H. Loebel has been with PharmaLex GmbH in Mannheim since 2005. He initially headed the Regulatory Operations department and has been Director and Principal Consultant Regulatory Operations Industry/Agency Liaisons since 2015. His responsibilities include managing electronic submissions, planning projects, and providing strategic advice to pharmaceutical companies.
More information please click here.
Edward Brown
Johnson & Johnson Innovative Medicine, SWITZERLAND
Global DRA Submission Leader
Gaetan Holvoet
Johnson & Johnson Innovative Medicine, SWITZERLAND
Manager RA Submissions Publishing
27/10/2026
27/10/2026
FROM 9:00-14:30 CET
online
online
Event - 990€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 990€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Jean-Marie Bayhurst
Konferenzmanager Pharma & Healthcare
+49 6221 500-685
j.bayhurst@forum-institut.de
Get up to speed on eCTD 4.0: EU timelines, technical changes, transition requirements and pilot learnings - all in one focused half-day session including a live demo.
This half-day seminar provides a focused and practical update on eCTD 4.0 - from regulatory timelines and technical changes to real-world transition experience.
You will gain a thorough understanding of the key differences between eCTD v3.2.2 and v4, including submission grouping and forward compatibility, and learn how to manage dossier lifecycles effectively under the new standard.
Drawing on real-world experiences from the EMA pilot and a live demonstration, you will leave with concrete guidance on what your organisation needs to prepare before making the switch to eCTD 4.0.
09:00 Introduction and technical warm-up
09:15
Karl-Heinz Loebel
10:15 Coffee Break
10:30
Karl-Heinz Loebel
12:00 Lunch break
13:00
Edward Brown, Gaetan Holvoet
14:00
Karl-Heinz Loebel
14:30 End of the seminar
Are you interested in broadening your regulatory horizon? This seminar can be booked as part of the qualification course 'Regulatory Affairs Manager', which provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional online trainings.
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
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.
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.
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