Module 3 2019

The Dossier Storyboard Inputs

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Type of application

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Product characteristics

▪ Problem formulation; data/information requirements in target market(s); essential vs. optional data Output ▪ A high-level narrative describing how different elements of the risk assessment “story” will be presented in the final dossier(s) ▪ Informs the regulatory science plan – e.g., list of required studies to be conducted; type of data to be generated

▪ The “story” drives data generation – NOT the other way around

▪ Needs to be “evergreen” – able to adapt to changes in regulatory policy, target markets, science, etc.

CMC Project Management

The Organisation for Professionals in Regulatory Affairs