CRT 2017 : Japan FDA - Using Real-World Evidence to Support Marketing, Post-Marketing Safety Measures and Regulatory Decisions

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Overview

Japan FDA - Using Real-World Evidence to Support Marketing, Post-Marketing Safety Measures and Regulatory Decisions

Featuring

  • Mitchell Krucoff
  • Hiroyoshi Yokoi
  • Pablo Morales
  • Jenny Andersen
  • Akihide Konishi

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Moment Components

Methods to Gather and Analyze RWE – US Academia - Mitchell Krucoff
Current Methodology and Future Horizons – Japanese Academia - Hiroyoshi Yokoi
Regulatory Perspectives on RWE – US Regulatory View - Pablo Morales
Issues and Current Experience Using RWE to Support Regulatory Applications – US Industry - Jenny Andersen
Using Post-Marketing Surveillance for Safety Measure – Japanese Regulatory View - Akihide Konishi

Target Audience

Learning Objectives

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