Regulatory Submissions, Information, and Document Management Forum

With the advent of ChatGPT and other large language model (LLM) solutions, regulatory, medical writing and other R&D organizations have been exploring how LLMs can be used to save time and resources, improve speed to market, and enhance regulatory compliance. In this session, we will share the work that sponsors and other companies are doing to take advantage of LLM technology, the approaches they are taking, and where they are having successes or dealing with challenges. We will discuss the kinds of regulatory problems or use cases that these solutions can potentially solve as well as inherent functionality gaps and risks to avoid when using LLM tools. For example, LLMs can have challenges providing references for summary text and can even “make up” information to fill a gap (aka, hallucination). Given the popularity of LLMs and widespread adoption by the public, we will also talk about how to govern the use of such technologies, especially to support regulated business processes. Lastly, we will address how LLMs change our ways of working, the potential new roles these automations will introduce, and skill sets we may need to add to our Regulatory teams. This session includes case studies, experiments and information gathered from sponsor firms, the DIA RIM Intelligent Automation Team, consultancies and software vendors.

Speakers share what they are doing with generative AI to enable efficiencies across regulatory and medical writing, approaches for managing the risk of such tools and governing their application, and how LLMs change how we work.