Course Content

1 Introduction to Technology Assessment in the Regulatory Context; Introduction to FDA

Course Overview

• 1 Introduction

Video
Slides
Quiz
Worksheet
References

2 Safety & Effectiveness

3 Regulatory Pathways

4 Clinical Trials

5 Quality Systems

6 Intl Regulation

References

Glossary

Summary

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What you will learn in this section

• Introduction to Technology Assessment in the Regulatory Context
• Courselet Overview
• Definition of Devices

Content

Play video

1. Jan Pietzsch on Technology Assessment and Regulation

Slides (PDF - 1 slide per page)

Speaker's Biographies

Jan Pietzsch

Additional Materials

Assessment Quiz

Worksheet (pdf)

References (doc)