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Session 6 Track 2: Optimizing Regulatory Operations Through the Application of Advanced Technologies
Session Chair(s)
Jake Doran
Head of Digital
Lykos Therapeutics, United States
Responding to health authority queries and identifying, analyzing, and making regulatory intelligence actionable, are two areas where human capital has been invested extensively to address needs that technology was historically unable to address. However, we are beginning to see and understand how the use of advanced technologies can be leveraged to optimize these and other business processes across the regulatory spectrum. Whether it is artificial intelligence (AI), machine learning (ML), natural language processing (NLP), or other advanced technologies, attendees of this session will leave with a better understanding of how these technologies can be utilized to transform how they conduct business across the regulatory spectrum.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify how these technologies can be applied to impact functions and processes within Regulatory Affairs
- Understand how AI and NLP can be used to enable users to respond to health authority questions accurately and efficiently
- Explain how regulatory intelligence can be utilized to support RIM processes and procedures during product life cycle
Speaker(s)
AI: Unstructured Content to Intelligent Analysis
Thomas P Kivlehan
Docxonomy, United States
Chief Data Officer
Response To Question Biographer (RTQB)
Leslie Kitchen, BSN, RN
Merck & Co., United States, United States
Senior Director Regulatory Innovation and Information Management
How Regulatory Intelligence empowers Regulatory Information Management
Olaf Schoepke, PhD
Samarind, United Kingdom
Vice President, Regulatory Solutions
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