CRED Understanding Clinical Development 2024

14/10/2024

Introduction

Day 2

Beatrix Friedeberg, Senior Director,

Regulatory Strategy, International

Global Regulatory Affairs, VERTEX

CRED Clinical Development

The Organisation for Professionals in Regulatory Affairs

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R&D Processes

Build up sufficient safety data 300-600 pts for 6 months

100 patients for 1 year 500-1500 total exposure

The Organisation for Professionals in Regulatory Affairs

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