Module 3 2019

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