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Session 9 Track 3: Taking Advantage of Generative AI to Optimize Regulatory & Medical Writing – Uses, Benefits and Risk Management
Session Chair(s)
Kristen Sauter, MBA
Senior Director, Head, Global RIM, Analytics & Digital Innovation
Takeda Pharmaceuticals, United States
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.
Learning Objective : At the conclusion of this session, participants should be able to:- Provide an overview of Generative AI
- Identify how sponsor companies are exploring the use of Generative AI in Regulatory and Medical Writing and how that may change ways of working
- Discuss approaches for governing Generative AI technologies and managing risks and limitations
Speaker(s)
Taking Advantage of Generative AI
Cary Smithson, MBA
LeapAhead Solutions, Inc., United States
Managing Partner
Speaker
Bikalpa Bikash Neupane, PhD
Takeda, United States
Head of AI and NLP
Can we Teach Language Models to Learn Facts?
Ari Caroline, MA, MBA
Weave, United States
CEO and Co-Founder
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