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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