Project Description

Case Study: Multi-year Partnership for CCDS (Core Company Data Sheet) Creation and Updates

Background – Client Needs:

Client Size:

A multinational pharmaceutical company

Geography:

Europe, US, Canada

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.

The client faced the following challenges:

  • 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).

The scope of Celegence’s activities was the creation and maintenance of the CCDS, through a team of experienced medical writers and medical reviewers with a good understanding of the processes and templates for CCDS used in the pharmaceutical industry and knowledge on the current regulatory environment.

Project Initiation & Key Objectives:

The client chose to leverage Celegence’s team of regulatory experts to support the CCDS creation and update based on our expertise and an operating model designed to deliver an end-to-end cost effective solution.

The client’s objectives involved realising the following business benefits via their outsourcing strategy:

  • Managing the complexities of CCDS creation (multiple formulations, MAH at different locations, managing health agency interactions)

  • Develop a consistent structure of the CCDS

  • Centralised approach to labeling

  • Inputs on evolving requirements and regulatory updates for the medicinal product

  • Providing justification for data in the CCDS to address HA queries

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:

  • 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

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.

Key Project Achievements

  • 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

Celegence delivered the following value and business impact to the client:

  • 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

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.

Find out more information on Celegence’s capability for creation and update of the company core data sheet

 

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