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DIA MASC

DIA MASC
Speakers and Posters

Session 5 Track 2: Direct Use of AI in Clinical Regulatory Document Development: Real-World Use

Session Chair: Diane Cleverley, PhD. Senior Regulatory Writer
Speaker: David Meats, Director, Regulatory Services Management

Recent advancements of AI tools have leveraged machine learning algorithms and natural language processing (NLP) techniques to enable AI models to learn from large datasets and generate more sophisticated and coherent written content; this can greatly assist medical writers by automating routine tasks such as data analysis and summarization, freeing up time for more complex and creative work, as well as ensuring consistency and accuracy in medical writing, particularly when generating reports or other documents that require strict adherence to specific formatting and style guidelines. This session presents real-world examples of AI utilization throughout the creation of clinical regulatory documents, demonstrating the potential benefits of integrating AI technology into the medical writing process. Such examples will include both positive and negative issues observed in live document writing cases of CSRs, Module 2 submission documents, and medical device writing. This informative session will explore the current use cases of AI tools and future development direction of several AI tools.

Learning Objective:

  • Evaluate the capabilities of an AI GPT-style chat tool to support clinical regulatory document development
  • Describe the abilities of an AI tool to facilitate the speed, accuracy and consistency of the creation of clinical regulatory documents of various types, including CSRs and Module 2 submission documents
  • Differentiate between different types of AI writing tools and their best use for regulatory document creation, base on real world use cases

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