Data at the Core: Understanding Your Company's Critical Yet Underutilized Tool

Description: Core Labeling which is called the Company Core Data Sheet (CCDS) is an internal regulatory document that is maintained by pharmaceutical companies to represent their position on the safety and efficacy profile of the product. CCDS is essential to support local labeling for a marketed product and to ensure consistency between various regional and global labeling. The CCDS is a multifaceted tool with known benefits regarding ensuring safe use in patients, but it is largely underutilized in the context of drug lifecycle management, alliance pharmacovigilance agreements, governance alignment, medical affairs launch strategy, development of patient materials and benchmarking from a safety perspective.

This session aims to address the practical challenges that are faced by the companies in the process of creating, maintaining, and implementing company core data sheets, with an emphasis on the inclusion of safety information. It’s important to know what to include and equally important to know what not to include. We will talk through the lifecycle of a CCDS based on the region the label is being prepared for and the different situations CCDS can be used as a tool beyond the labelling context.

Using examples from the real world, this session plans to discuss everything you need to know about the CCDS, starting with the general guidelines to explaining the ‘what’, ‘how’, ‘when’, and ‘who’ of the CCDS authoring process, to implementation of core labeling principles to regional labeling and finally the review and approval by the regulatory agencies.