Webcode 26062601
Alexander Maur
Kanzlei am Ärztehaus Partnerschaft mbB, Cologne (Bayenthal), GERMANY
Lawyer and Partner;
Alexander Maur has been a partner at the law firm since 2007 and advises the healthcare industry on issues relating to pharmaceutical and medical device law and associated areas of law at the firm's Cologne-Bayenthal office.
More information please click here.
Mike Liang (PhD)
AlphaLife Sciences, SINGAPORE
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.
Dr. Sabrina Stöhr
Merck Healthcare KGaA, Darmstadt, GERMANY
Associate Director Medical Writing After her studies in human and molecular biology and research in cell biology, Sabrina Stöhr focussed on clinical research. For more than 10 years, she has been working as a medical writer on the preparation of clinical authorisation documents in various therapeutic areas. She deepened her expertise with a Master's degree in Drug Regulatory Affairs (DGRA).
17/06/2026
17/06/2026
from 09:00 -17:00 CET
You may dial-in 30 minutes before
online
online
Event - 1,290€ plus tax
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 €
Event - 1,290€ plus tax
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 covers legal aspects such as data protection, regulatory compliance, and transparency obligations, including specific requirements from GMP Annex 11 and Annex 22.
Throughout the seminar, you will gain an overview of a wide range of AI tools, including their advantages and limitations. During a live workshop, you will gain practical insights into how AI can be used effectively and safely 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
Dr. Sabrina Stöhr
10:00 Coffee Break
11:15
Alexander Maur
12:00 Lunch break
13:00
Mike Liang (PhD)
14:30 Coffee Break
14:45
Dr. Sabrina Stöhr
15:45 Short Break
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).
Simply register for the seminar by clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€490 + local VAT rather than €590 + local VAT).
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 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.
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.
of 5 stars of all ratings from 2025
of 5 stars on Trustpilot = good
- Registration possible until 09.03.26 - Are you new to pharmacovigilance and looking to kick-start your career? Then th...
We will focus on how to integrate compliance and governance into Medical Affairs activities and ensure quality documenta...
- Registration possible until 17.02.26 - Enhance your skills in writing key pharmacovigilance safety documents. In two-d...
You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with...
Sind Sie als RA-Professinal im Bereich der Marktzulassung für die Erstellung der Qualitätsdokumentation von pharmazeutis...
Expand your competencies in drug regulatory affairs in a practice-oriented manner with up to 30% price advantage.
Details
We provide flexible education and training with high-quality e-Learning programmes for several topics.
Details
More than 3,700 customers have rated our training courses. Thank you for awarding us 4.4 stars out of 5.
Details
