Module 3 Presentations

07/05/2024

The Dossier Storyboard Inputs  Type of application  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

35

New Product Formats and Processes

• Requires a rethinking of the CMC setup and capabilities • Demand a high knowledge of the drug product • CMC must more tightly align with research • Needs closer dialogues with regulatory agencies in order to confidently know what scientific evidence will be demanded • Demands much more capacity for analytical testing

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

36