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AI/Software

Navigating the future: Embracing AI and ChatGPT in Regulatory Affairs and Quality Management for Pharma and MedTech Professionals Alike

Tuesday, May 7, 2024
16:45 – 17:45 CEST
Location: B 09
Learning Level: Advanced
Description: This session is a deep dive into the future of regulatory affairs and quality management in the Pharma and MedTech industries, highlighting the transformative role of AI. Paul Kuiken, Andreas Kalchschmid-Lehmann, and Grace Fu will guide participants through an exploration of current and future use cases for AI and ChatGPT, and the leadership challenges they present.

Participants will first explore strategic leadership implications and the transformational impact of digital technology in regulatory affairs and understand how this shift impacts the future of the Pharma and MedTech industries. The session will then pivot to a focused discussion on the role of AI in improving quality management and regulatory affairs, offering practical insights and collaborative exploration of AI use cases. Finally, practical examples and uses of ChatGPT for regulatory professionals will be presented, highlighting its benefits, limitations, and practical applications in the global regulatory landscape.

This comprehensive session aims to prepare all levels of professionals for the rapidly evolving digital landscape in regulatory affairs and quality management, equipping them with the knowledge and tools necessary for strategic adaptation and effective utilization of emerging technologies.

Learning Objectives:

  • Develop a thorough comprehension of the strategic aspects and challenges within the changing regulatory environment due to new digital technologies, focusing on critical factors for change from literature and empirical studies, and apply this insight to advance innovative strategies and leadership.
  • Acquire practical knowledge on integrating AI into regulatory and quality management processes and identify key applications, benefits, and challenges of AI in these fields, and develop a comprehensive understanding of potential AI use cases in regulatory affairs and quality management.
  • Examine the main characteristics and distinctions between ChatGPT versions 3.5 and 4.0, focusing on their use in enhancing regulatory and clinical communication, learning, and summarization, and learn to utilize ChatGPT for global regulatory comprehension and overcoming language barriers, while acknowledging its limitations.