Skip to main content
RAPS Convergence 2024 Main banner
Evaluation ViewAttendees 46

Devices (includes Medical Devices and In Vitro Diagnostics)

Standardization of Clinical Study Design

Wednesday, September 18, 2024
9:15 AM - 10:30 AM PDT
Location/Room: 104 C
The pre- and post-market clinical data requirements are increasing globally, and the interest of the global patient remains the same to have safe and effective devices when used as intended. This session will dive into the challenges related to Europe, USA, and China and discuss the best approaches to meet global regulatory requirements by addressing patient and healthcare system needs.

Learning Objectives:

  • Upon completion, participant will be able to apply basics in clinical investigation design for medical devices that ensure clinical evidence for market access
  • Upon completion, participant will be able to understand common pitfalls in defining study design
  • Upon completion, partiicpant will be able to apply principles of quantifying endpoints