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Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations
Session Chair(s)
Ethan Chen, MBA, MS, PMP
Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
FDA, United States
This panel will discuss opportunities and challenges of leveraging artificial intelligence (AI) in the drug development lifecycle, especially in regulatory operations. The panel will include representation from regulatory, and industry.
Learning Objective : Identify the impact of artificial intelligence (AI) in the drug development lifecycle from health authorities' and, industry's perspectives; Recognize opportunities for the regulators and industry to leverage rapid advancement of AI to the drug development lifecycle; Discuss challenges to implement changes from policy, technology, standard, data security in regulatory operations.
Speaker(s)
The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Hilmar Hamann, PhD
European Medicines Agency, Netherlands
Head of Information Management
Panelist
Tala Fakhouri, PhD, MPH
FDA, United States
Associate Director for Data Science and Artificial Intelligence, Office of Medic
Panelist
Nicole Mahoney, PhD
Novartis Pharmaceuticals Corporation, United States
Executive Director US Regulatory Policy & Intelligence
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