Transcription of NIMPs (v IMPs): Definitions and Practical Approaches
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NIMPs (v IMPs): Definitions and Practical Approaches
NIMPs (v imps ): Definitions and Practical Approaches Esther Sadler-Williams Global Director Strategic Development and Innovation 18th November 2015 2015 Catalent Pharma Solutions. All rights reserved Note: contributions are based on the individual s knowledge and expertise; this presentation should not be construed as a statement or opinion by Catalent Pharma Solutions. Disclaimer 2015 Catalent Pharma Solutions. All rights reserved 1 2 Agenda Current Status Definitions - Practical Approaches to Management Sourcing Labelling and Packaging Traceability, Complaints, Recalls, Adverse Events Impact of New CT regulations Summary 2015 Catalent Pharma Solutions. All rights reserved Current Status - Define a NIMP? Background Medication Concomitant meds Escape / Rescue meds Diagnostic / Endpoint Medications Preventive Medication Not being tested Challenge / Physiologic response meds Commercial products?
4 Current Status Regulatory Environment • Currently no regulations around NIMPS • Guidance from the European Commission* — Defines nIMPs, provides examples, and required filing documentation Non-Investigational Medicinal Product (NIMP) * A medical product not defined within the description of …
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