The Application of Artificial Intelligence/Machine Learning in Drug Development and Regulation

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 begins with an overview of AI/ML fundamentals, then summarizes AI/ML-related regulatory submissions at CDER/FDA. She will share review and research examples, then discusses 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).

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

2:12 Introduction
4:22 Dr. Qi Liu Opening Statement
5:27 Outline
12:03 Types of Machine Learning
14:00 Challenges in the Application of AI/ML
15:02 Landscape Analysis for AI/ML Related Submissions at CDER/FDA
19:25 Regulatory Considerations for AI/ML in Drug Development
36:18 Take Home Messages

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