CRED 8 Presentations

03/07/2024

Regulatory Environment

Drug delivery device with drug as primary mode of action (PMOA) – combination product

Investigational Device

Approved Device

Known Drug

+

++

Investigational Drug

+++

++++

+  ++++ : indicates increasing difficulty of approval process

The Organisation for Professionals in Regulatory Affairs

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Strategic Considerations Coordination of Drug delivery device & Drug Development

Post-market survey Post market clinical follow up Materio-vigilance Changes CE mark, pricing & reimbursement, launch, Life cycle

Design Verification

Feasibility

Design Validation

MD

Construction, manufacturing, controls and biocompatibility / animal studies (proof of concept)

Clinical studies in association with MP Parallel usability studies (formative and final HF validation studies)

Research

Levels of interaction

Phase II studies (dose ranging, PK PD, safety) MD recommended (previous versions)

Phase III efficacy/safety studies MD required (final version)

Post-market survey Phase IV studies Pharmacovigilance Variations MAA, pricing & reimbursement, Launch, life cycle

Chemical, manufacturing and controls, and Pre Clinical studies

Phase I safety studies MD not mandatory

Research

MP

Pharmaceutical and non clinical development

Formulation

Clinical development

The Organisation for Professionals in Regulatory Affairs

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