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Bethesda North Marriott Hotel and Conference Center

Apr 23, 2019 7:00 AM - Apr 25, 2019 5:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

CMC Workshop

Explore how to utilize effective CMC strategies and execution and how it can help to reduce regulatory burden, enable shorter review timelines, and support post-approval maintenance.

Back to Agenda

Session 6 - Quality Metrics - QM Feedback Program, 2018 QM Site Visit Program

Session Chair(s)

M. Scott Furness, PhD

M. Scott Furness, PhD

Deputy Director, Office of New Drug Products, OPQ, CDER

FDA, United States

Session 6 - Quality Metrics - QM Feedback Program, 2018 QM Site Visit Program

Speaker(s)

Lucinda F. Buhse, PhD

Quality Metrics: Quality Metrics Feedback Program, Quality Metrics Site Visit Program

Lucinda F. Buhse, PhD

FDA, United States

Director, Office of Surveillance, OPQ, CDER

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