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Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance
Session Chair(s)
Melissa Herman, MSC
Senior Specialist, Patient Insights
Lundbeck A/S, Denmark
With several regulatory and ethics authority initiatives to encourage patient input to trial design, how should sponsors communicate this information in submissions and how can authorities provide aligned review, guidance and expectations towards these activities?
Learning Objective : Discuss US and EU initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from survey on sponsor submission/advice experience and guidance needs; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance
Speaker(s)
Industry Perspective
James Valentine, JD, MHS
Hyman, Phelps & McNamara, PC, United States
Director
Industry Perspective
Lesley Maloney, PHARMD
Genentech, A Member of the Roche Group, United States
Regulatory Policy Lead
Industry Perspective
Elizabeth Lange, MPH, MS
EMD Serono, United States
Executive Director/ Head of Regulatory Scientific Policy
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