Module 3 Presentations

14/05/2024

Overview

• Some basics and 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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Enhancing your submission - data

• Follow the guidelines – or justify fully where you do not. Should you seek scientific advice rather than “take the risk”?

• Present data in a logical manner – justify key decisions with data. Present key data within the correct section; avoid annexing multiple reports.

• Own your data! • Acknowledge missing or inconsistent data and out of specification results.

• Evaluate data that is out of trend or has an adverse trend. Justify acceptability (remember the “positivity sandwich”!)

The Organisation for Professionals in Regulatory Affairs

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