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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.

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Session 7 Track B: Q13 Continuous Manufacturing

Session Chair(s)

Derek Vrieze, MSc

Senior Associate Regulatory-CMC

Vertex Pharmaceuticals, United States

This session focuses on perspectives of continuous manufacturing (CM) from both FDA and industry perspective. Vertex Pharmaceuticals will share learnings from the commercialization of 2 CM processes. FDA will summarize initiatives to support new developments in the manufacture of biotechnology products, the current state of CM and a forward looking discussion about new CM modalities and a brief discussion of ICH Q13.

Speaker(s)

A Fearless Approach to Continuous Manufacturing

Gregory Connelly

Vertex Pharmaceuticals, Inc., United States

Bioburden Control Strategy for Continuous Manufacturing: FDA’s Perspective

Scott Nichols, PhD

FDA CDER, United States

Microbiologist

FDA’s Perspective on the Advancement of Continuous Manufacturing

Rapti Madurawe

FDA, United States

Chemist

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