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Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance
Session Chair(s)
Melissa Pauline 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 can authorities provide aligned review, guidance and expectations towards these activities and how should sponsors communicate patient engagement?
Learning Objective : Discuss US (FDA) and EU (EUCTR and country ethics committees) initiatives for systematic conduct and documentation of patient input to trial design; Explain learnings from sponsor survey on sponsor submission/advice experience and guidance needs; Understand gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance; Describe emerging markets.
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