Module 3 Presentations

14/05/2024

• Proof-read for inconsistencies between sections, typographical errors, illegibility of graphs or figures... • If including information that is not in English, provide a notarised translation. • Try to ensure that data and data discussion are captured on the same page • Avoid tables “breaking” across multiple pages • Use tables or graphs to analyse key data e.g. trend graphs for stability parameters. Enhancing your submission - presentation

The Organisation for Professionals in Regulatory Affairs

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Summary - tips for a successful MAA (& happy assessor!)

• The quality of the dossier is key to the success of a regulatory submission

• Consider what it will be like to assess your dossier - if it doesn’t make sense to you, then the regulator doesn’t stand a chance…!

• Present logical, evidence-based decisions supported by data - summarise where appropriate (… but don’t omit key information). • Where the gap assessment highlights significant risk (scientific or regulatory) – consult the regulator

The Organisation for Professionals in Regulatory Affairs

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