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
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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
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