Webcode 25122601
Tim De Smedt
UCB S.A.
Regional Regulatory Science Lead, Neurology EU Global Regulatory Affairs
Alexander Maur
Kanzlei am Ärztehaus Partnerschaft mbB, Cologne (Bayenthal), GERMANY
Lawyer and Partner
More information please click here.
Mike Liang (PhD)
AlphaLife Sciences
Head of AI Product and Strategy; Dr. Mike Liang is an accomplished product leader with over 19 years of experience in designing, launching, and scaling successful AI/ML solutions across major technology companies. Holding a Ph.D. in Biomedical Informatics from Stanford University, Mike has served as a Group Product Manager at Google, where he led cross-functional teams driving product innovation. With deep expertise in artificial intelligence and a strategic approach to technology development, Mike now leads AI product strategy and innovation at AlphaLife Sciences, where he focuses on advancing the next generation of clinical technology solutions that bridge cutting-edge AI capabilities with life science applications.
01/12/2025
01/12/2025
from 09:00 -17:00
You may dial-in 30 minutes before
online
online
Veranstaltung - 1,290 € zzgl. MwSt.
Die Teilnahmegebühr beinhaltet eine Dokumentation zum Download, ein Zertifikat, den Zugang zum Learning Space sowie technische Betreuung einschließlich PreMeeting.
SPECIAL OFFER
e-Learning: Common Technical Document and eCTD
, online
Your booking advantage: You book the seminar at the regular price and add the e-learning. The price of the e-learning is reduced by €100 (€490 instead of €590 plus VAT)
490,00 €
Veranstaltung - 1,290 € zzgl. MwSt.
Die Teilnahmegebühr beinhaltet eine Dokumentation zum Download, ein Zertifikat, den Zugang zum Learning Space sowie technische Betreuung einschließlich PreMeeting.
SPECIAL OFFER
e-Learning: Common Technical Document and eCTD
, online
Your booking advantage: You book the seminar at the regular price and add the e-learning. The price of the e-learning is reduced by €100 (€490 instead of €590 plus VAT)
490,00 €
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
This seminar explores how artificial intelligence can be effectively and responsibly integrated into regulatory writing processes. You'll gain insights into legal requirements, learn about AI tools and technologies, and see how they apply to CTD documentation through practical examples and a live demonstration.
This seminar provides you with a comprehensive overview of how artificial intelligence (AI) can support and enhance regulatory writing.
You'll learn about the fundamental principles of regulatory documentation and the opportunities and risks that arise when integrating AI-based tools into writing workflows. The seminar also includes legal aspects such as data protection, regulatory compliance, and transparency obligations. Through real-world examples and a live demonstration, you'll gain practical insight into how AI can be effectively and safely used in regulatory dossier writing.
By the end of the seminar, you'll understand how to use AI responsibly in the preparation of regulatory documents while maintaining quality and compliance.
09:00 Welcome & Technical Warm-Up
09:15
Tim De Smedt
10:00 Coffee Break
10:15
Alexander Maur
11:45 Lunch break
12:45
Mike Liang (PhD)
14:15 Coffee Break
14:30
Tim De Smedt
16:00
Mike Liang (PhD)
16:45
17:00 End of the seminar
Do you need foundational knowledge on the structure and content of the CTD/eCTD? Then this e-Learning 'Common Technical Document and eCTD' is the ideal fast track. It will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.
It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type. Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).
Upon completion, you will be proficient in CTD/eCTD principles and well equipped to prepare compliant regulatory dossiers.
You will receive a €100 discount if you book the seminar "AI in Regulatory Writing" and the e-learning together (you will be billed €490 + local VAT rather than €590 + local VAT). A 90-day access account is available and you can start immediately after registering.
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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