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Bethesda North Marriott Hotel and Conference Center

Apr 20, 2015 8:30 AM - Apr 22, 2015 4:30 PM

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

DIA/FDA Statistics 2015 Forum

Session 11: FDA and Industry Town Hall

Session Chair(s)

Lisa  LaVange, PhD

Lisa LaVange, PhD

Professor Emerita

University of North Carolina at Chapel Hill, United States

Walter  Offen, PhD

Walter Offen, PhD

Global Head of Statistical Innovation & Safety Statistics

AbbVie Inc, United States

This session will be an open-microphone and broad Q&A session. Panelists will address questions posed by attendees in one of several manners: Via e-mail before or during the meeting, writing questions on 3x5 cards available at the registration desk, or by asking them live at the session. Topics may focus on the sessions held at this meeting, but can also branch out into other areas of regulatory statistics.

Speaker(s)

Walter  Offen, PhD

Panelists

Walter Offen, PhD

AbbVie Inc, United States

Global Head of Statistical Innovation & Safety Statistics

Jerald  Schindler, DrPH

Jerald Schindler, DrPH

Strategic Statistics, United States

Chief Executive Officer

Armin  Koch, DrSc

European Subgroup Guidance

Armin Koch, DrSc

Hannover Medical School, Germany

Head, Institute of Biometry

Christine  Fletcher, MSc

Christine Fletcher, MSc

GlaxoSmithKline, United Kingdom

VP/Head, Speciality and Primary Care Statistics

Nevine  Zariffa

Nevine Zariffa

Astrazeneca Pharmaceuticals, United States

Vice President and Head Biometrics & Information Sciences

Rajeshwari  Sridhara, PhD

Rajeshwari Sridhara, PhD

FDA, United States

Senior Biostatistician Consultant, Oncology Center of Excellence, FDA

John  Scott, PhD, MA

John Scott, PhD, MA

FDA, United States

Division Director, Office of Biostatistics, CBER

Steve  Wilson, PhD

Steve Wilson, PhD

FDA, United States

Senior Staff Fellow, OB, OTS, CDER

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