Name: Patient Engagement in Trial Design and the Evolving Landscape of FDA, EMA and Country Authority Guidance
Start: 2025-06-17T16:00:00-0400
End: 2025-06-17T17:00:00-0400

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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 Objectives

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; Identify gaps and opportunities for authority (regulatory and ethics committee) harmonization in expectations and guidance; Describe emerging markets.

Chair

Melissa Pauline Herman, MSc

Speakers

Melissa Pauline Herman

Senior Specialist, Patient Insights, Lundbeck A/S, Denmark

Melissa Herman is a Senior Specialist in the H. Lundbeck A/S Global Patient Insights team, working to systematically integrate patient experience data and engagement across neurology and neuro-rare development programs.

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Global Perspectives, Clinical Trial Design, Patient Experience
Level Intermediate
format csv
Feature Topics Global Perspectives,Clinical Trial Design,Patient Experience
Tags Session

DIA 2025 Global Annual Meeting

Melissa Pauline Herman

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