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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
AbbVie, United States
Director, Patient Experience Data and Strategy
EMA Response (Via Telecommunications)
Maria Begona Isaac, MD, PhD, MS, MSc
European Medicines Agency, Netherlands
Senior Scientific Officer, Product Development Scientific Support Department
OPDP Response
Elaine Hu Cunningham, PharmD
FDA, United States
Sr. Regulatory Review Officer, OPDP, CDER
Panel Discussion Moderator
Jessica Voqui, PharmD, MS
FDA, United States
Regulatory Review Officer, Study Endpoints and Labeling Development, CDER
Panelists
Elaine Hu Cunningham, PharmD
FDA, United States
Sr. Regulatory Review Officer, OPDP, CDER
Maria Begona Isaac, MD, PhD, MS, MSc
European Medicines Agency, Netherlands
Senior Scientific Officer, Product Development Scientific Support Department
Elektra Papadopoulos, MD, MPH
AbbVie, United States
Director, Patient Experience Data and Strategy
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