Module 3 Presentations

14/05/2024

Things to consider…scientific advice • May be product-specific or broader scope

• Advice can only be given on the basis of the documentation provided

Not legally binding

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• Requires briefing document with clear questions and Company’s justification of their position

• Does not represent pre-assessment; ask specific questions  Here is the entire module 3.2.S; is it acceptable?

 Does the Agency agree with the choice of regulatory starting materials?

The Organisation for Professionals in Regulatory Affairs

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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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