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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 3: FDA White Paper on Patient Centric QOS and Current Topics at FDA Including Data Standards and KASA

Session Chair(s)

Cheryl Emery

Associate VP, GRACS and Global Head CMC Pre-Approval Pharmaceuticals

Merck Research Laboratories, United States

Session 3: FDA White Paper on Patient Centric QOS and Current Topics at FDA Including Data Standards, KASA, and Allotrope

Speaker(s)

FDA White Paper on Patient Centric QOS – FDA Perspective

Ramesh K. Sood, PhD

FDA, United States

Senior Scientific Advisor (Acting), Office of New Drug Products, CDER

Industry Experience with Patient Centric QOS

Connie Langer, MSc

Pfizer Inc, United States

Senior Director

Overview and Current FDA Position on Data Standards

Norman Schmuff, PhD

FDA, United States

Associate Director for Science, OPMA, OPQ

Overview and Current FDA position on KASA

Geoffrey Wu, PhD

FDA, United States

Deputy Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA

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CMC Workshop

Session 3: FDA White Paper on Patient Centric QOS and Current Topics at FDA Including Data Standards and KASA

Session Chair(s)

Cheryl Emery

Speaker(s)

FDA White Paper on Patient Centric QOS – FDA Perspective

Industry Experience with Patient Centric QOS

Overview and Current FDA Position on Data Standards

Overview and Current FDA position on KASA

Be informed and stay engaged.