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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 2 Track C: Human Factors

Session Chair(s)

LeeAnn L Chambers, MS

Principal Research Scientist, Global Regulatory Affairs, CMC - Devices

Eli Lilly and Company, United States

Session 2 Track C: Delivery Systems for Generic Drugs

Speaker(s)

The Role of Human Factors Engineering in Combination Product Design and Development

Quynh Nhu Nguyen, MS

FDA, United States

Associate Director for Human Factors, DMEPA, CDER

Regulatory Strategies for Autoinjectors - Challenges, Expectations and Reality

Prasad Peri, PhD

Teva Pharmaceutical, United States

Senior Director of Regulatory Affairs CMC

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