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Location

Zoom

About This Event:

This virtual workshop will be hosted by the newly established FDA Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE). The purpose of this workshop is to introduce the CDER QM CoE, providing an overview of the scope, goals, and current state, while gaining feedback from the public on needs and opportunities in education, outreach, and policy.

Background:

QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care. The newly established CDER QM CoE is a coordinating body intended to spur innovation and foster comprehensive integration of QM approaches to advance therapeutic medical product development and promote public health. As part of its goal to engage the drug development, research, and patient communities, the QM CoE is holding this workshop to orient stakeholders its mission and scope and to dialogue on opportunity areas.

Workshop Objectives:

• Provide an overview of the newly formed QM CoE, including discussion of the current goals, initiatives, and priority areas
• Engage with stakeholders to inform future QM CoE initiatives in education, outreach, and policy development

Meeting Information:

For questions regarding this event, please contact CDERQuantMed@fda.hhs.gov.