CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
Multi-year Partnership for CCDS (Core Company Data Sheet) Creation and Updates
Project Summary
The client sought out a partner to create Company Core Data Sheets for a portfolio of products, including authoring CCDS documents from scratch, as well as review and updates to existing CCDS documents.
Project Deliverables
Development of a global Company Core Data Sheet (CCDS) for harmonisation of regulatory labeling.
Understanding and defining the end-to-end process for CCDS creation.
Ensuring that the most current information is included in the CCDS.
Updating the existing CCDS (content as well as format).
Celegence Solution & Approach:
Celegence was awarded a contract for the creation of Company Core Data Sheet Before initiation of the activities, a CCDS template was developed. The CCDS template was such that it would be easy for regulators to find specific information. The activities performed as a part of the process are listed below: The final output from Celegence was a CCDS with up to date and consistent safety and efficacy information. Along with the CCDS, documentation was also provided as part of the process, such as literature search output, case report evaluations and HA recommendations. The key to success of the project was proactive planning, an effective end-to-end process and good communication, discussion, and the exchange of information between SMEs and the client POC, all aiding in the commitment to meet the ultimate goal of patient safety.
Highlights:
Detailed discussion by SMEs with client point of contact (POC) for devising strategy for CCDS creation which includes local challenges, HA queries and recommendations
Gap analysis of source data to identify deviations
Impact analysis for inclusion or exclusion of the deviations into the CCDS
Analysis of post-marketing data for any signals
Literature search and review of any risk and safety concern
A comprehensive summarisation and justification for all the safety topics
Health Authority website search to identify any class effects, decisions, and other recommendations
Preparation of the draft CCDS taking into consideration the content of the local labels and any relevant recommendations
Distribution of the draft CCDS to client stakeholders
Project Achievements
An important part of CCDS creation is the preparation of core safety information (CSI), as this information must be available to submit with the PSURs. Regulators need to know what changes have been performed by the MAH during the time period of the PSUR for companies that have a product sold in multiple countries, having a CCDS, which includes the CCSI, is the sensible approach. If a change is performed in CCSI, it would drive changes in the local product information throughout the world. The process helps in coordinating the maintenance of safety information helping achieve the same safety standards for regulators, prescribers and the patients ultimately improving patient safety.
Work instructions detailing the process and individual roles and responsibilities
CCDS template meeting client expectations
CCDS draft which met the necessary compliance standards with clarity of presentation
Medical justification document with discussion and conclusion on significant safety issues, reflecting any changes to the benefit-risk balance of the medicinal product
Comprehensive, stable and consistent product information with extensive safety information
Harmonisation of the core safety information and local labels (SmPC, USPI or product monograph)
Reduction of operational cost and compliance with multiple regulatory agencies
Ensuring greater content consistency across a broad range of products across multiple regions
Maintenance of patient safety as well as brand integrity
Find out more information
on Celegence’s capability for creation and update of the company core data sheet
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25 Mar, 2025
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