AI in Regulatory Writing
- Practical use of AI tools
- Legal and compliance insights
- Complies with AI Regulation Art. 4 for certified AI competence
- Officially certified to ISO 9001 and ISO 21001 standard
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
Die Teilnahmegebühr beinhaltet eine Dokumentation zum Download, ein Zertifikat, den Zugang zum Learning Space sowie technische Betreuung einschließlich PreMeeting.
Period:
from 09:00 -17:00 CET
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
Die Teilnahmegebühr beinhaltet eine Dokumentation zum Download, ein Zertifikat, den Zugang zum Learning Space sowie technische Betreuung einschließlich PreMeeting.
Period:
from 09:00 -17:00 CET
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.
Your speakers
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…
Your speaker
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.
Mike Liang (PhD)
AlphaLife Sciences, New Jersey, US
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…
Your speaker
Mike Liang (PhD)
AlphaLife Sciences, New Jersey, US
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.…
Your speaker
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).
What to Expect
- Key principles of regulatory writing
- Legal framework and compliance risks of AI in regulatory writing (including GMP-Annex 11 and Annex 22)
- Introduction to AI: Functionality, technology and terminology
- Practical tools and best practices for AI-supported writing workflows
- Use of AI in CTD writing (focus on clinical part)
- Interactive workshop
Who Should Attend
This seminar is designed for regulatory affairs professionals and medical/regulatory writers working in the pharmaceutical industry who are interested in understanding and applying AI tools in their regulatory writing processes. Basic knowledge of drug approval processes and the regulatory dossier is required.
Professionals from the following departments will also benefit from the seminar topics: Clinical development, medical affairs, and IT & digital innovation.
Objective of the Event
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.
Your Benefit
- Gain a foundational understanding of AI and its relevance in regulatory writing
- Understand how to identify compliance risks and legal limitations of AI use
- Discover a variety of AI tools for drafting, structuring, and summarising documents
- Learn how AI can support medical writing tasks
- Ensure compliance with AI Regulation Art. 4 through certified AI competence training
- Experience AI-assisted writing in a hands-on workshop session
Programme
from 09:00 -17:00 CET
09:00
09:15
Dr. Sabrina Stöhr
- Key characteristics & requirements
- In which use cases can AI play a role?
10:00
10:15
Alexander Maur
- Overview of the current legal framework for AI
- Specific requirements from GMP Annex 11 and Annex 22
- Potential risks of AI in regulatory submissions
- Data protection & business secrets
12:00
13:00
Mike Liang (PhD)
- General overview on AI & AI history
- How is AI built?
- How to apply AI in regulatory writing scenarios
- Tools & technologies
- Prompting models & best practices
14:30
14:45
Dr. Sabrina Stöhr
- Overview of AI tools for regulatory writing workflows
- Using AI for structuring and summarising regulatory documents
- Use cases and prompting templates
- Limitations and human review requirements
15:45
16:00
Dr. Sabrina Stöhr, Mike Liang (PhD)
- Live demo of AI-assisted regulatory writing
16:45
- Summary of key takeaways
- Q&A
17:00
Welcome & Technical Warm-Up
09:15
Regulatory Writing - Key Principles
Regulatory Writing - Key Principles
Dr. Sabrina Stöhr
- Key characteristics & requirements
- In which use cases can AI play a role?
Coffee Break
10:15
Limitations & Compliance Risks of AI in Regulatory Writing
Limitations & Compliance Risks of AI in Regulatory Writing
Alexander Maur
- Overview of the current legal framework for AI
- Specific requirements from GMP Annex 11 and Annex 22
- Potential risks of AI in regulatory submissions
- Data protection & business secrets
Lunch break
13:00
AI Support in Regulatory Writing
AI Support in Regulatory Writing
Mike Liang (PhD)
- General overview on AI & AI history
- How is AI built?
- How to apply AI in regulatory writing scenarios
- Tools & technologies
- Prompting models & best practices
Coffee Break
14:45
Dossier Writing with AI Support
Dossier Writing with AI Support
Dr. Sabrina Stöhr
- Overview of AI tools for regulatory writing workflows
- Using AI for structuring and summarising regulatory documents
- Use cases and prompting templates
- Limitations and human review requirements
Short Break
16:00
Interactive Workshop
Interactive Workshop
Dr. Sabrina Stöhr, Mike Liang (PhD)
- Live demo of AI-assisted regulatory writing
16:45
Closing Discussion & Feedback Session
Closing Discussion & Feedback Session
- Summary of key takeaways
- Q&A
End of the seminar
More Options
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).
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.
Weitere Informationen
Tailored training for your company: In-house seminars
- Online, on-site, and hybrid formats
- Available in German and English
- Customised programmes
Would you like to cost-efficiently train multiple employees in your company on a regulatory affairs topic? This seminar is an example of our proven in-house training programmes. Whether you need an existing seminar concept, a specialised topic, or a tailored training for your organisation, we are here to support you!
I would be delighted to plan your in-house training with you. Please feel free to contact me by phone or email. I look forward to your enquiry!
Jean-Marie Bayhurst I Conference Manager Pharma/Healthcare
I Mail:
j.bayhurst@forum-institut.de
I Telefon: 06221 500-685
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.
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.
Our Recommendations
Further Information
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