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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• Medicines and Healthcare products Regulatory Agency • Executive Agency of the UK Department of Health • Responsible for ensuring that medicines and medical devices work and are acceptably safe • www.mhra.gov.uk The MHRA

The Organisation for Professionals in Regulatory Affairs

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