AI in Regulatory Writing

- 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 -Registration deadline: 16 June. Remaining places subject to availability.- This seminar explores how artificial intelligence can be effectively and responsibly integrated into regulatory writing processes. Youll 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.LernzieleThis seminar provides you with a comprehensive overview of how artificial intelligence (AI) can support and enhance regulatory writing. - Youll 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, youll understand how to use AI responsibly in the preparation of regulatory documents while maintaining quality and compliance.ZielgruppenThis 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.