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Bethesda North Marriott Hotel and Conference Center

2018 年 04 月 23 日 1:00 下午 - 2018 年 04 月 25 日 4:15 下午

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

DIA/FDA Biostatistics Industry and Regulator Forum

Session 10: Senior Leaders (FDA and Industry) Town Hall

Session Chair(s)

Dionne  Price, PhD

Dionne Price, PhD

Deputy Director, Office of Biostatistics, OTS, CDER

FDA, United States

Cristiana  Mayer, DrSc, PhD

Cristiana Mayer, DrSc, PhD

Head of Biostatistics

Johnson & Johnson Vision, United States

Welcome to the Town Hall! Dedicated to sharing the latest information on new guidances, this session will allow open discussion between the audience and an esteemed panel of regulatory and industry experts. Questions asked from the audience may focus on the sessions held during this forum, but can also branch out into other areas of regulatory statistics. Panelists will address questions posed by attendees live from the Town Hall as well as those submitted throughout the forum.

Speaker(s)

Jose C. Pinheiro, PhD

Jose C. Pinheiro, PhD

Janssen Research & Development, LLC, United States

Head of Statistical Modeling and Methodology, SDS

Nevine  Zariffa

Speaker

Nevine Zariffa

Astrazeneca Pharmaceuticals, United States

Vice President and Head Biometrics & Information Sciences

Ram  Tiwari, PhD, MS

Speaker

Ram Tiwari, PhD, MS

Bristol Myres Squibb , United States

Head of Statistical Methodology

John  Scott, PhD, MA

John Scott, PhD, MA

FDA, United States

Division Director, Office of Biostatistics, CBER

Pandurang M Kulkarni, PhD

Pandurang M Kulkarni, PhD

Eli Lilly and Company, United States

Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics

Aloka  Chakravarty, PhD

Aloka Chakravarty, PhD

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

Director, Data Analytics

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