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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 , FDA CDER, 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)
Hilmar Hamann, PHD
Chief Information Officer, European Medicines Agency, Netherlands
The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Tala Fakhouri, PHD, MPH
Chief AI & Regulatory Strategy Officer, Parexel, United States
Panelist
Nicole Mahoney, PHD
Executive Director US Regulatory Policy & Intelligence , Novartis, United States
Panelist
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