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Navigating Instrument Development Using the Wheel and Spokes
Session Chair(s)
Jessica Voqui, PharmD, MS
Regulatory Review Officer, Study Endpoints and Labeling Development, CDER, FDA, United States
Speaker(s)
Roadmap to Patient Focused Outcome Measurements in Clinical Trials
Elektra Papadopoulos, MD, MPH
Director, Patient Experience Data and Strategy, AbbVie, United States
EMA Response (Via Telecommunications)
Maria Begona Isaac, MD, PhD, MS, MSc
Senior Scientific Officer, Product Development Scientific Support Department, European Medicines Agency, Netherlands
OPDP Response
Elaine Hu Cunningham, PharmD
Sr. Regulatory Review Officer, OPDP, CDER, FDA, United States
Panel Discussion Moderator
Jessica Voqui, PharmD, MS
Regulatory Review Officer, Study Endpoints and Labeling Development, CDER, FDA, United States
Panelists
Elaine Hu Cunningham, PharmD
Sr. Regulatory Review Officer, OPDP, CDER, FDA, United States
Maria Begona Isaac, MD, PhD, MS, MSc
Senior Scientific Officer, Product Development Scientific Support Department, European Medicines Agency, Netherlands
Elektra Papadopoulos, MD, MPH
Director, Patient Experience Data and Strategy, AbbVie, United States
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