Bethesda North Marriott Hotel and Conference Center

2017 年 02 月 06 日 7:00 上午 - 2017 年 02 月 08 日 5:00 下午

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

Regulatory Submissions, Information, and Document Management Forum

Plenary Session 1: FDA - PDUFA V Update

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Advisor, Office of Regulatory Operations, CBER

FDA, United States

Plenary Session 1: FDA - PDUFA V Update

Speaker(s)

Adam  Kroetsch

REMS

Adam Kroetsch

Duke-Margolis Center For Health Policy, United States

Research Director, Biomedical Information and Regulatory Policy

Aaron  Niman, MPH

Sentinel

Aaron Niman, MPH

FDA, United States

Research Officer, Office of Surveillance and Epidemiology, CDER

Aloka  Chakravarty, PhD

Biomarkers and Adaptive Trial Design

Aloka Chakravarty, PhD

Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States

Director, Data Analytics

Ginny  Hussong

PDUFA VI Informatics Preview

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

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