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AI in Drug & Biological Product Development: FDA & CTTI Workshop
August 6, 2024 @ 10:00 am - 5:30 pm
Free
AI holds great potential to transform how drugs are developed, manufactured, and utilized. As with any innovation, AI use in drug development creates new and unique challenges that require both careful management and a risk-based regulatory framework that is built on sound regulatory science approaches that support innovation. Join us as we explore guiding principles that are being applied by innovators and regulators to promote the responsible use of AI in the development of safe and effective drugs. Learn from experts about applying principles for good machine learning practices to ensure responsible use of AI in the development of drugs. Drawing on real case examples, we will discuss the rationale for particular approaches, how success was evaluated, what challenges were encountered, options for scaling and wider applicability, and considerations for moving forward.
On Tuesday August 6, 2024 from 10 AM to 5:30 PM EDT, FDA and the Clinical Trials Transformation Initiative are hosting a free hybrid public workshop on artificial intelligence (AI) in drug and biological product development.
Please join us as we explore the guiding principles being applied by innovators and regulators to ensure AI is used responsibly. AI holds great potential to transform how drugs are developed, manufactured, and used.
Participants may attend virtually or in-person in the FDA Great Room located at 10903 New Hampshire Avenue, Silver Spring, MD 20993.
Registration information can be found here.
The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
