Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

Preamble

• Biological/nonclinical assessment is not a tick-box process

• Rather, a qualified individual developing an evaluation programme based on the specifics of the device/drug is required

• Purpose: to assure safety for patient or user

The Organisation for Professionals in Regulatory Affairs

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Example

Established oral drug

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• Proposal to incorporate into an implantable device to provide clinical benefit

The Organisation for Professionals in Regulatory Affairs

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