2026-03-22 2026-03-22 , online online, 1,290 € zzgl. MwSt. AI in Regulatory Writing

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.

Themen
  • 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.
Ziel der Veranstaltung
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.
Teilnehmerkreis

  • 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

Course: AI in Regulatory Writing

AI in Regulatory Writing

Benefits
  • 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

Webcode 26062601

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Termin

17/06/2026

17/06/2026

Zeitraum

from 09:00 -17:00 CET
You may dial-in 30 minutes before

from 09:00 -17:00 CET
You may dial-in 30 minutes before
Veranstaltungsort

online

online

Gebühr
Your contact

Jean-Marie Bayhurst
Conference Manager

+49 6221 500-685
j.bayhurst@forum-institut.de

Details

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.

Themen

  • 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.

Ziel der Veranstaltung

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.

Teilnehmerkreis

  • 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