This ASCPT webinar is Part 3 of 4 in the Systems Pharmacology Educational Webinar Series. This session is intended to provide the audience with clear examples of how quantitative systems pharmacology (QSP) predictions of efficacy and safety have contributed to regulatory interactions/decisions, as well as clear examples of how the US Food and Drug Administration has reviewed QSP submissions. With these specific examples as a backdrop, the panel, which includes additional industry representatives, will provide broader perspectives on QSP in regulatory science, including challenges and opportunities. Broadly, this session will demonstrate the value of QSP in regulatory interactions.

Learning objectives:

• Understand the potential for QSP to guide regulatory decisions.
• Clarify regulatory expectations for QSP credibility and adoption.
• Highlight regulatory challenges and broader perspectives.

PANELISTS:

• Richard Allen, Ph.D.
• Guansheng Liu, Ph.D.
• Lisl Soda, Ph.D. 
• Kyunghee Yang, Ph.D.
• Tatiana Iakovleva, Pharm D