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Overview This white paper is intended to be used as an educational tool to assist the reader in the following areas:
- Develop a deeper understanding of Product Information Management (PIM)
- Discuss the goals and benefits of PIM
- Understand the impact that PIM will have on your current regulatory approval process
- Identify additional resources for broadening PIM knowledge
There are multiple sources of information (presentations, meetings, Web sites and documents) that address PIM including: "Exchange of Product Information Specifications," "Data Exchange Standard (DES) Change Control Procedure" and "Product Information Management Business Process" available from the EMEA's eSubmission Web site. Please refer to the PIM Resources chapter. This paper is meant to augment, not replace, existing PIM information, and attempts to pull many of the topics from these various sources together into a single, comprehensive document.
Who Should Read This Document
This document provides a comprehensive overview of PIM covering both business and technical topics. As such, this document is appropriate for the following roles that have responsibility for labelling content within pharmaceutical and biotechnology companies, or other firms that have products approved by an EMEA Centralised Procedure:
- Regulatory Affairs Managers and Directors
- Information Technology Managers and Directors
- Informatics Resources
- Scientific Writers
- Other roles responsible for creation, management and submission of product information content to the EMEA
Executive Summary
In today's complex global life sciences marketplace, the ability to manage product information is a daunting task. Many departments across the enterprise use the approved product information for a variety of purposes, including package and labelling, promotional materials, and product Web sites. It is common practice for each department to take a copy of the approved content and recreate it for its own use, leading to significant process inefficiencies and potential for inconsistent product information.
Additionally, there are many consumers of this product information including regulatory authorities, academic research centres, health care professionals and the general public. These people depend and rely on accurate and consistent information about drug products independent of the manner in which they access this information, whether through paper-based, electronic or other channels.
The ability to ensure greater control over this critical product information has led to the development of a standard for product information throughout the European Union. This standard is the Product Information Data Exchange Standard (PIM-DES). It is being used by the European Agency for the Evaluation of Medicinal Products (EMEA) to allow for submission of product information of centrally approved products as a series of XML files rather than as Microsoft Word and Adobe PDF documents.
EMEA has been given a mandate by the European Council to reduce by 30 days the time required to process a centrally approved product. The DES will aid in reducing the approval time by:
- Streamlining the review process by reducing the amount of repeated information in documents
- Reducing the amount of information to be translated into the required EU languages
- Allowing EMEA to exchange document fragments with companies to reduce the overall volume of data exchanged and reviewed
If your company has not begun to think about PIM, now is the time to start. To take advantage of the improved approval process you will need to be able to:
- Submit centralised procedures in a manner that conforms to the DES specification
- Receive XML fragments from EMEA and resubmit the same fragments after modification
- Incorporate XML information in your data translation workflow
Although various options exist for submitting DES-compliant files, you will find that creating and managing labelling content in XML has significant advantages over bolting a PIM solution on top of traditional authoring approaches. Structured labelling content can help your organization address key business drivers such as:
- Reducing non-compliance risk by eliminating redundant sources of product information and ensuring all documents contain the correct information at all times and adhere to emerging health authority standards
- Improving the quality of product information outputs and reducing the time and cost associated with managing product information by eliminating manual tasks associated with the creation, review, approval and publishing of labelling content in multiple forms, both print and electronic
- Increasing efficiency of labelling content management processes and improving overall time to market
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