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Bethesda North Marriott Hotel and Conference Center

2024 年 02 月 12 日 8:00 上午 - 2024 年 02 月 14 日 2:30 下午

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Session 8 Track 3: Modern Applications of Innovative Technologies in Regulatory Processes

Session Chair(s)

Neel  Patel, MS

Neel Patel, MS

Director of Technology, Epista Life Science, United States

This session will focus on real life examples of artificial intelligence (AI), robotic process automation (RPA), and large language model (LLM) applications in regulatory functions. From RPA bots to AI-driven solutions, technological advancements in the industry are aiding organizations to streamline their day-to-day operations. Companies can leverage technology to complete mundane tasks allowing resources to focus on more strategic work. However, applying advanced technology can inherit risk to an organization and must be used with caution to avoid misinterpretation and data invalidity.

Learning Objective :
  • Describe AI, RPA and LLM applications in Regulatory and analyze the efficiencies to be gained in organizational processes while ensuring compliance
  • Employ best practices for adopting advanced technology in your Regulatory function to ensure outputs are compliant with industry standards
  • Hypothesize the validity of data output from modern technologies in Regulatory use cases and discuss the risks and limitations of leveraging technological advancements

Speaker(s)

Kavya Chowdary Chowdary Konka, MS

Kavya Chowdary Chowdary Konka, MS

Sr Manager Medical Writing Operations, AbbVie, United States

Case Study: Using Robotic Process Automation to optimize the process of compiling Clinical Study Reports

Vladimir  Penkrat, MBA

Vladimir Penkrat, MBA

Associate Vice President – Regulatory Affairs, Indegene, United States

Leveraging modern technologies for resolving complexities in Health Authority Query Response generation and tracking

Venkatraman  Balasubramanian, MBA

Venkatraman Balasubramanian, MBA

Healthcare and Life Sciences Strategic Advisor, VB Insights, LLC, United States

Generative AI for Regulatory Intelligence – More Questions than Answers?

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