CRED Getting the CMC Dossier Right 2024

28/08/2024

Control of Medicinal Products

Paul Marshall

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Agenda

• What is a Finished Product Specification?

• How do Finished Product Specifications evolve?

• Universal and Product Specific Tests

• European Regional Requirements

• Analytical Procedures and Validation

Justification of Specifications

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Role of Pharmacopoeias

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The Organisation for Professionals in Regulatory Affairs

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