Module 3 Presentations

14/05/2024

Overview

• Some basics & principles of assessment • Working with the Regulators • The “hot topics”: Major deficiencies in the drug substance and drug product • How to minimise delays to approval from module 3 (… ensuring a happy Regulator!)

The Organisation for Professionals in Regulatory Affairs

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Why care about quality?

• Why do the pharmaceutical (quality) aspects of a medicine matter?

… Surely demonstration of safety and efficacy is enough?

• Chemistry, Manufacturing & Control … ● Impurity profile, physical characteristics? ● Formulation, manufacture and presentation fit for purpose? ● Stability? ● Assurance of GMPs? ● Robustness / Reproducibility?

The Organisation for Professionals in Regulatory Affairs

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