Module 9
Other Sections, Other Aspects
The type and depth of content of a CCDS' Clinical Studies section can be subject to controversial discussions in labeling decision-making committees. Often, the reason for such discussions is lack of transparency of the use case for a CCDS at the specific point in a product’s life cycle. Depending on a company's internal drug development processes and approach to life-cycle management, a CCDS's use case may change greatly over time. Some companies will even find that, for them, there is no practical need to have a CCDS in place at the time of first submission of a new product and that any CCDS created at a later time can do very well without a Clinical Studies section. Similar considerations apply to other CCDS sections and to the question whether or not a CCDS needs to contain references.
Time and effort can be wasted by creating elaborate content for certain CCDS sections and by creating and maintaining references if there is no sufficient use case for such information.
Curriculum topics of this module include:
- Critical review of use cases for an elaborate Clinical Trials section at various points of a product's life cycle.
- If a Clinical Trials section is created and maintained, what content model to apply (US style, EU style, other)
- Maintaining clinical pharmacology and preclinical safety information in a CCDS
- Critical review of use cases for references in a CCDS
- Alternatives to including references in a CCDS
- The changing content of a CCDS/CCSI Dosage and Administration section for an aging product
- Basic risk information outside the Adverse Reactions section – where it may reside and how to highlight it, if necessary