You are here: Home Products  Registration Planning & Tracking  MPDmanager (XEVMPD & IDMP) 

Benefits

  • Ready for the future: XEVMPD and IDMP compliant
  • Reuse of content increases efficiency and accuracy (nonrecurring data entry)
  • Reduced costs by automated processes and reuse of content (including
    advanced searches) to collect and maintain information
  • Integrates with the EXTEDOsuite, product databases and other RIMS to provide one product information standard
  • Excel & XML based interfaces for data import and export from various sources
  • Wizard based data entry
  • Lifecycle Management including versioning and workflow functionality for automated approval processes
  • Web based

MPDmanager (XEVMPD & IDMP)

The Challenge

The European Medicines Agency (EMA) recently announced a new pharmacovigilance legislation, describing the modernization of its  pharmacovigilance system, with the goal of improving patient safety and health information to patients. The new legislation which requires companies to resubmit medicinal product data has wide consequences on information management and business process for pharmaceutical companies. In addition to the sizable technical challenges companies have a short timeline in which to adapt to and implement the initial phase. The new EU pharmacovigilance legislation has to be supported from 2nd July 2012 for all authorized products in Europe following the XEVMPD standard.

Furthermore the attempt to define and establish the “Identification of Medicinal Product (IDMP)” standard until 2015 as a global harmonized electronic exchange format seems the biggest change in the regulatory
registration process today.

To comply fully with this new standard, business will undoubtedly face challenges. It will be required for authorized products in Europe to submit all product information in the new XEVMPD standard. This new requirement far exceeds in volume and content the current EVMPD standard and ultimately requires all information presently in the EMA database to be resubmitted in
order to comply with the new standard.

The Solution – XEVMPD compliant and IDMP
ready now!

Compared to pure XEVMPD data entry solutions, EXTEDO MPDmanager can both be utilized as a stand-alone XEVMPD & IDMP solution and was also designed as a Master Data sharing platform combining information from different resources.
As part of the EXTEDO Regulatory Information Management Suite, the MPDmanager will share Regulatory Master Data with other EXTEDOsuite components as well as third party products. This holistic approach to regulatory information management allows companies to easily enter, import and share all relevant regulatory master information of global product data across the
enterprise and easily comply with new data submission regulations.

Functional overview

  • A standardized database allows the guided entry and automated imports of all regulatory data requested by XEVMPD and IDMP. It also allows for the management of additional product attributes to comply with corporate standards regarding:
    • Medicinal products (product name, country, version, regulated document, medicinal product classification)
    • Packaged medical products (packed item, manufactured item, batch identifier, shelf life, storage, data carrier identification, package, physical characteristics)
    • Medical devices (device batch identification, device nomenclature, device characteristics)
    • Pharmaceutical products (ingredients, specified substance, substances, strength, reference strength, PHPID set, route of administration, Pharmaceutical product characteristics)
    • Manufacturing (manufacturing operation, medicines regulatory agency, marketing authorization holder)
    • Marketing (marketing authorization procedure and application, PSUR, marketing status)

  • XEVMPD author system
    • IDMP and XEVMPD database as the base of all data entry
    • Editor containing data entry masks for:
      • Organization (information about the MAH)
      • Attachments (reference to SmPC)
      • Approved substances
      • Standard terminology
      • Authorized products
    • Authoring guide incl. examples
    • Data entry supported by wizards
    • Use and update of controlled vocabulary list
  • Support of schema rules provided by the EMA
  • Reuse of Content
    • Simple ways to reuse content which might contain functionalities like: Content finder, look-ahead combo boxes, reuse of parents and child, reuse from a library
    • Reuse of ID provided by EMA for new substances, products etc.
    • Possibility to version the content from the entire XEVPRM file as well as from the individual modules
  • Adoption of Validation rules
    • The system will run a schema and business rule validation
    • XEVPRM validation on demand
  • Data exchange via gateway
    • Submitting content via the Eudravigilance Gateway
    • Handling of the XEVPRM_ack file
    • Handling of the provided IDs
    • Handling of the Controlled Vocabulary
    • Handling of the provided XEVPRM examples
  • Lifecycle Management
    • Indication of lifecycle status for each
      object
    • Versioning of data sets (Medicinal Product, Pharmaceutical Product,
      Substance, Organization etc.)
    • Versioning of XEVPRMessages
    • Workflows for review, release and approval processes

Further functionalities are an XEVPRM export and rich user management including audit trial and multi tenant capability as well as a full integration in the EXTEDOsuite.