Module 18 - Drug Device Combinations and Other Technologies

13/12/2023

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

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