Update eCTD 4.0
Requirements, Timelines and Transition Strategies
- Focused half-day format
- Practical transition guidance
- Live demo & discussion
- Officially certified according to ISO 9001 and 21001
Online-Seminar
Ab
990,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 990,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
FROM 9:00-14:30 CET
Buchungsdetails
Online-Seminar
Ab
990,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 990,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
FROM 9:00-14:30 CET
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.
Your speakers
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…
Your speaker
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.
Edward Brown
Johnson & Johnson Innovative Medicine, THE NETHERLANDS
Global DRA Submission Leader
Your speaker
Edward Brown
Johnson & Johnson Innovative Medicine, THE NETHERLANDS
Global DRA Submission Leader
Gaetan Holvoet
Johnson & Johnson Innovative Medicine, THE NETHERLANDS
Manager RA Submissions Publishing
Your speaker
Gaetan Holvoet
Johnson & Johnson Innovative Medicine, THE NETHERLANDS
Manager RA Submissions Publishing
What to Expect
- Regulatory updates and current timelines
- Key technical changes compared to v3.2.2: submission grouping, forward compatibility and dossier migration
- Best practices for dossier lifecycle management under eCTD 4.0
- Transition preparation: internal readiness & learnings from the EMA pilot
- Practical live demo & discussion
Who Should Attend
This seminar is aimed at regulatory affairs professionals and submission managers responsible for eCTD dossier preparation and lifecycle management. It is also relevant for regulatory operations teams and anyone involved in planning or executing the transition to eCTD 4.0.
Participants are expected to have a solid understanding of EU regulatory procedures.
Objective of the Event
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.
Your Benefit
- You gain an up-to-date overview of eCTD 4.0 timelines and regulatory requirements
- You understand the key technical changes compared to v3.2.2 and how they affect your submission practice
- You learn how to plan and execute a successful transition from eCTD v3.2.2 to v4
- You benefit from pilot learnings and a live demo
Programme
9:00 - 14:30 CET
Karl-Heinz Loebel
- Why eCTD 4.0 and how companies should prepare
- Current timelines (EU focus, with global comparison)
- Relationship between ICH M4Q and eCTD v4 and its impact on timelines
Karl-Heinz Loebel
- Key changes and updates compared to v3.2.2
- Submission grouping: What it is and how it can be used
- How to successfully transition from eCTD v3.2.2 to v4
- Forward compatibility: migration of existing applications (EU status?)
- Best practices for dossier lifecycle management under eCTD 4.0
Edward Brown, Gaetan Holvoet
- Internal readiness: what needs to be in place before switching
- Common pitfalls and how to avoid them
- Learnings from the eCTD 4.0 pilot
Karl-Heinz Loebel
Introduction and technical warm-up
Regulatory Updates and Timelines
Regulatory Updates and Timelines
Karl-Heinz Loebel
- Why eCTD 4.0 and how companies should prepare
- Current timelines (EU focus, with global comparison)
- Relationship between ICH M4Q and eCTD v4 and its impact on timelines
Coffee Break
Technical Changes and Transition
Technical Changes and Transition
Karl-Heinz Loebel
- Key changes and updates compared to v3.2.2
- Submission grouping: What it is and how it can be used
- How to successfully transition from eCTD v3.2.2 to v4
- Forward compatibility: migration of existing applications (EU status?)
- Best practices for dossier lifecycle management under eCTD 4.0
Lunch break
Transition Preparation in a Pharmaceutical Company
Transition Preparation in a Pharmaceutical Company
Edward Brown, Gaetan Holvoet
- Internal readiness: what needs to be in place before switching
- Common pitfalls and how to avoid them
- Learnings from the eCTD 4.0 pilot
Practical Live Demo & Discussion
End of the seminar
Downloads
List of abbreviations "Drug Regulatory Affairs and CMC"
Weitere Informationen
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.
Access to and procedure for online events
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.
Our Recommendations
Informationsbeauftragte - Fokus Packmittel
Seminar für Informationsbeauftragte: Rechtliche Grundlagen der Arzneimittelkennzeichnung, Verantwortungsabgrenzung, SOPs und praktische Fehlerquellen-Prävention.Sprache: Deutsch
NIS, PASS und RWE nach der Zulassung
In dem eintägigen Online-Seminar erhalten Sie einen praxisnahen Überblick, wie Sie Sicherheitsfragestellungen und potenzielle Signale nach der Zulassung strukturiert untersuchen und regulatorisch…Sprache: Deutsch
Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E
E&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation…Sprache: Englisch
Outsourcing & Vendor Oversight in Regulatory Affairs
Overview of RA outsourcing & vendor oversight: risk-based vendor selection, governance and compliance controls. Practical and compact in just half a daySprache: Englisch
Market Access of Biosimilars in Europe
Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market accessSprache: Englisch
Further Information
Qualification Course Regulatory Affairs Manager
Expand your competencies in drug regulatory affairs in a practice-oriented manner with up to 30% price advantage.
DEMO-Account e-Learning
Try out our e-Learning programmes free of charge and without any obligation.
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de