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Bethesda North Marriott Hotel and Conference Center

Feb 13, 2023 11:30 AM - Feb 15, 2023 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 6 Track 2: Optimizing Regulatory Operations Through the Application of Advanced Technologies

Session Chair(s)

Jake  Doran

Jake Doran

Managing Director, List Innovations, 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)

Thomas P Kivlehan

Thomas P Kivlehan

Chief Data Officer, Docxonomy, United States

AI: Unstructured Content to Intelligent Analysis

Leslie  Kitchen, BSN, RN

Leslie Kitchen, BSN, RN

Senior Director Regulatory Innovation and Information Management , Merck & Co., United States, United States

Response To Question Biographer (RTQB)

Olaf  Schoepke, PHD

Olaf Schoepke, PHD

Vice President, Regulatory Solutions, Samarind, United Kingdom

How Regulatory Intelligence empowers Regulatory Information Management

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