Company Core Data Sheets
& Core Safety Information
- High quality, efficient and competitively priced.
- A unique opportunity for Clients to reduce the time and resource burden of creating CCDS and Company Core Safety Information (CCSI), and to build their own expertise by having their staff collaborate with our experts.
- Providing complete project service as well as individual service elements (see below).
- For a stable marketed product, if the process outlined below is followed, the creation of a CCDS that is limited to CCSI might not take more than 80 hours of work by Pharmiceutics, in addition to the data gathering, review and decision making work by the Client.
The creation of a CCDS for a marketed product does not have to take 6-12 months. With expert assistance and guidance, it can be a 4-weeks project.
The roll-out of a new CCDS for an established product does not have to be a difficult experience for headquarters, affiliates and regulatory authorities. The solution: A set of Core information, designed with local labeling requirements and implementability in mind, plus well-designed supporting rationales and documentation.
Background
A Company Core Data Sheet (CCDS) is a company-internal global reference labeling document used to direct the content of local (affiliate) labeling. The CCDS may also be used as an attachment to a Periodic Safety Update Report (PSUR); in this context, all the safety information in a CCDS ("Company Core Safety Information" or "CCSI"), or a specifically identified (e.g. by bold print) subset of this safety information, serves as reference information for determining "listedness".
A CCDS may be created for a new product, to be available at the time of a first submission of local labeling in a first market, or at any later point in a product's life cycle. Ideally, a CCDS is already available at the beginning of the first PSUR period for the second market that requires a PSUR.
The type and depth of information in a CCDS depends on how "active" the product is. The content of a CCDS written for a "mature, stable" product (no new indications or uses planned to be added) may be limited to CCSI, accompanied by a brief description of the product's uses as necessary to interpret the CCSI.
A CCDS for a new, active product may contain all information that most local affiliates might need to draft local labeling.
The CIOMS III/V and VI guidelines describe some general criteria for including safety information in a CCDS/CCSI. However, labeling regulations, guidelines and expectations have significantly changed and become more specific since the CIOMS III and III/V reports were published. Taking these developments into account is crucial from a regulatory and legal/litigation point of view. Equally important for the regulatory viability and defensibility of CCDS and CCSI content and for labeling harmonization are carefully drafted and effective rationales and supporting documentation.
Our unique experience in the field of labeling, and Core labeling in particular, makes Pharmiceutics the ideal resource for companies that create or revise CCDS and CCSI and harmonize local safety labeling.
Creating a CCDS/CCSI for a Stable, Marketed Product
For this task, we suggest the following standard process:
- The process typically begins with a comparative analysis of the content of local labels. Based on English language label texts provided by the Client, Pharmiceutics prepares a labeling comparison table that highlights labeling similarities and differences. We use state-of-the-art criteria for determining the relevance of differences between labels.
- Following a telephone conference in which we explain selected findings and decision options, the Client then
- (a) reviews the documentation, (b) evaluates both information that already exists in all labels and information that is missing in some labels, and (c) determines which elements deserve to be included in the CCDS/CCSI.
- This step may also include the creation of new information that is not yet in any local label.
- Before a final decision is made to include a statement that is not yet persent in ALL local labels (i.e. that requires regulatory submission in one or more markets) rationales and supporting documentatin are prepared. This is also to verify implementatibility upfront, before roll-out. In this context, Pharmiceutics provides guidance on the type and depth of required rationales and documentation. We are also available for drafting rationales and assembling documentation.
- Based on Client feedback Pharmiceutics drafts a document that, after further Client review, evolves into the final draft CCDS for approval by the Client's labeling committee.
Upon request, Pharmiceutics provides its CCDS template to the Client. This template (accompanied by instructions for CCDS authors and affiliate staff) reduces the implementation difficulties and workload that could result from a CCDS structure that, for example, mimics the EU SPC structure and conventions.
Service Components
- Drafting Company Core Data Sheets (CCDS), including Company Core Safety Information.
- Setting up a Company Core Data Sheet Log (history document) for the recording of later CCDS updates.
- Preparing baseline comparisons of Local Labels (LL)*.
- Preparing baseline comparisons with comparator labeling*.
- Preparing a draft CCDS-LL gap analysis to identify the need for supporting rationales/documentation for regulatory submission.
- Drafting supporting rationales and expert statements for finalization by the Client's in-house experts, including collection and collation of supporting documents; ordering submission quality copies of publications.
- Preparing comparisons between final draft CCDS/CCSI and comparator labeling*.
- In the framework of an ongoing project, providing CCDS/CCSI-related expertise and, if required, participation in the Client's review and decision-making conferences.
- If requested, use of templates for CCDS and CCDS Log, and CCDS Manual (detailed guidance on CCDS section content).
* To be provided by the Client in English; if requested by the Client, translations can be obtained through Pharmiceutics.
Training
We offer public and in-house Core labeling seminars.