Knowledge Check: Good AI Practice Introduction

Test your understanding of why these principles exist, their scope across the drug life cycle, and the FDA–EMA collaboration.

Passing score: 70%

1. In the FDA–EMA document, AI refers to system-level technologies used across which phases of the drug product life cycle?

2. The Guiding Principles of Good AI Practice in Drug Development is a joint FDA–EMA international harmonisation document.

3. According to the document, drug authorisation requires demonstrated quality, efficacy, and safety when: