Artificial intelligence/machine learning (AI/ML) are increasingly being utilized in drug development. As pharmaceutical companies incorporate these new technologies, it is critical to understand their current strengths and limitations and how their use will be viewed by regulatory agencies. Dr. Qi Liu is the Associate Director for Innovation & Partnership at the Office of Clinical Pharmacology/Office of Translational Sciences at the Center for Drug Evaluation and Research (CDER).

In this webinar, Dr. Liu will begin with an overview of AI/ML fundamentals, then summarize AI/ML-related regulatory submissions at CDER/FDA. She will share review and research examples, then discuss challenges and regulatory considerations for AI/ML in drug development and regulation. Don’t miss this opportunity to learn how to effectively leverage AI/ML in your development programs.

Presenter: Dr. Qi Liu, Associate Director for Innovation & Partnership at the Office of Clinical Pharmacology/Office of Translational Sciences at the Center for Drug Evaluation and Research (CDER), FDA.

Moderator: Tom Sun, Vice President, Strategic Consulting Services, Clinical Pharmacology & Pharmacometrics Solutions