Module 1
The CCDS as a Corporate Labeling Control Tool
Long before the CIOMS III Working Group recommended that the safety information in a company's global labeling reference document be used to determine listedness for the purposes of Periodic Safety Update Reports (PSURs), some pharmaceutical companies had such corporate reference documents in place to control local labeling content. The primary purpose of a Company Core Data Sheet (CCDS) is to provide headquarters' reference labeling information to local affiliates. As the keystone of a robust and reliable global labeling control system, a CCDS is typically embedded in a set of business rules that define, for example:
- The role of CCDS vis-à-vis other sources of local labeling content
- General implementation directions for types of core information (eg, "mandatory safety information," "optional information")
- The intended level of consistency between CCDS and local labeling in terms of content and emphasis
- When affiliates have to seek headquarters’ prior approval for intended/unavoidable deviations from CCDS content
The features of a well-designed CCDS help to proactively clarify headquarters' implementation expectations. Its structure and authoring guidelines should not force core statements to higher "section ranks" than necessary (eg, due to a simplistic adoption of the EU SPC structure and the EU SPC authoring guidelines), thereby reducing the need to document (eg, for legal reasons) that a lower-level rank of a statement in local labeling is appropriate despite a higher rank in the CCDS.
A good CCDS organizes content into semantic units that, wherever possible, do not overlap and are worded with pristine clarity, using international terminology. Safety content, in particular, is presented with the rules of effective risk communication in mind. Adverse reaction tables/lists are designed to provide a good starting point for a further refined presentation of adverse reactions information in local healthcare professional labeling (respecting local information and presentation requirements); a good CCDS' adverse reaction tables/lists are not simply "term dumps" optimized for easy assessment of listedness. In addition, a good CCDS permits granular markup of content to indicate the implementation categories of statements or phrases (such as "mandatory" or "optional").
Curriculum topics of this module include:
- General principles of the use of a CCDS as the keystone of a company-internal regulatory system to direct local labeling
- Core labeling without CCDSs; pros and cons of using approved local labeling as global reference documents
- Definitions: CCDS, Development CCDS, target labeling, Company Core Safety Information, Development Core Safety Information, local labeling, Target Product Profile
- Level of safety information to be included in a CCDS; what should be mandatory for local implementation
- How to deal with the increasing amount of safety information released by regulatory authorities "outside of labeling"
- Core healthcare professional information and core patient information
- The scope of CCDS content and a core labeling system: Medical content, pharmaceutical content, administrative content – What makes sense? What does not?
- Possible CCDS formats and features
- Pros and cons of local labeling formats as templates for CCDS structure and section content
- Maintenance and storage of references and supporting documentation
- Content microstructure and effective paragraphing
- Partial repetition and cross-referencing in a CCDS
- Business rules for the processing of CCDS content by local affiliates
- Criteria for determining whether local labeling is “sufficiently similar” to core labeling
- Who can decide whether a local deviation from core safety information is acceptable
- Keeping records of deviations from core labeling and their history
- Principles of implementation tracking
- Main sources of potential labeling ambiguity
- Consistent use of terminology
- Writing a CCDS in English for foreign-language readers
- Beginning with prevention of medication errors in the CCDS