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Bethesda North Marriott Hotel and Conference Center

18 mar 2014 8:30 a.m. - 20 mar 2014 4:00 p.m.

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

Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

Session Chair(s)

Jessica  Voqui, PHARMD, MS

Jessica Voqui, PHARMD, MS

Regulatory Review Officer, Study Endpoints and Labeling Development, CDER

FDA, United States

Speaker(s)

Elektra  Papadopoulos, MD, MPH

Roadmap to Patient Focused Outcome Measurements in Clinical Trials

Elektra Papadopoulos, MD, MPH

AbbVie, United States

Director, Patient Experience Data and Strategy

Maria Begona Isaac, MD, PHD, MS, MSC

EMA Response (Via Telecommunications)

Maria Begona Isaac, MD, PHD, MS, MSC

European Medicines Agency, Netherlands

Senior Scientific Officer, Product Development Scientific Support Department

Elaine  Hu Cunningham, PHARMD

OPDP Response

Elaine Hu Cunningham, PHARMD

FDA, United States

Sr. Regulatory Review Officer, OPDP, CDER

Jessica  Voqui, PHARMD, MS

Panel Discussion Moderator

Jessica Voqui, PHARMD, MS

FDA, United States

Regulatory Review Officer, Study Endpoints and Labeling Development, CDER

Elaine  Hu Cunningham, PHARMD

Panelists

Elaine Hu Cunningham, PHARMD

FDA, United States

Sr. Regulatory Review Officer, OPDP, CDER

Maria Begona Isaac, MD, PHD, MS, MSC

Maria Begona Isaac, MD, PHD, MS, MSC

European Medicines Agency, Netherlands

Senior Scientific Officer, Product Development Scientific Support Department

Elektra  Papadopoulos, MD, MPH

Elektra Papadopoulos, MD, MPH

AbbVie, United States

Director, Patient Experience Data and Strategy

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