Module 15 Presentations

15/04/2024

Lecture 9: Clinical Global Strategy Requirements – Focus on US FDA Specifics

Richard A. VINCINS NAMSA Principal Strategy Consultant

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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• Planning & guidance to help think strategically • Benefit Risk Assessments • Early Feasibility Clinical US Program • Breakthrough Technology Designation / Safer Technology Designation • Use of Foreign Data in FDA submissions • IDE Submissions • Benefits of Q-Submission Program • IDE Requirements • Other Considerations • Clinical study size for PMA/Class III devices: US versus EU • Diversity Planning Agenda

The Organisation for Professionals in Regulatory Affairs

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