Module 18 2021

07/02/2021

Clinical studies with DDCs

1. Factor in device and meds expectations

2. Look at Performance / Efficacy of the Device ● As well as the drug product formulation

3. Human Factors studies

● Collected within the CTA protocol

4. Monitor safety of DEVICE and DRUG

The Organisation for Professionals in Regulatory Affairs

37

The Organisation for Professionals in Regulatory Affairs

38

19