MPDmanager Powered by CARA - EXTEDOs IDMP Software and Master Data Management Solution

This video provides an in-depth exploration of EXTEDO's MPDmanager, a regulatory information and activity management solution powered by CARA and integrated into the broader EXTEDO pulse platform. It addresses the escalating challenge of managing complex product information while adhering to an ever-changing global regulatory landscape. The solution aims to offer a comprehensive approach to all product and lifecycle-related topics within the pharmaceutical and life sciences industries, emphasizing a user-friendly and intuitive interface to streamline the organization and management of controlled vocabularies, master product data registrations worldwide, and associated activities.

The MPDmanager platform is designed with a focus on user efficiency and data integrity. Its interface features a customizable toolbar, a navigation tree for browsing and selecting data records, and a central main view panel for displaying information. Users can subscribe to records for change notifications, add items to a favorites list, and create or utilize predefined tags for quick access to information. The system supports individual filtering, export of data to Excel, and advanced search functionalities that can be saved and shared among colleagues. A dedicated widget panel provides detailed information about highlighted records, including version history and related activities, ensuring a holistic view of product data.

A core strength of MPDmanager lies in its robust regulatory compliance features, particularly its integrated Controlled Vocabulary (CV) management. This system incorporates SPOR vocabularies, ensuring that product data is, by default, compliant with XEVMPD and IDMP standards. These controlled vocabularies are centrally managed and utilized across the entire platform to construct product data, beginning with the "core product" concept. The core product serves as a country and region-independent corporate template, designed to facilitate the easy creation of registration information by reusing already available data. This foundational approach ensures consistency and efficiency, with the "registered product" then displaying country-specific data for planned or registered products, providing essential business-relevant data for overviews, reports, and detailed information that can be easily exported or transmitted in a compliant XEVMPD/IDMP format.

Beyond data management, MPDmanager significantly streamlines the regulatory submission process. It enables effortless creation and management of medicinal product registrations, allowing users to add specific data using free text, calendars, or controlled vocabularies, often by simply adjusting existing core product information. The system facilitates the planning of multiple activities for one or more products, integrating warnings for upcoming deadlines and allowing planned activities to be related to change requests. A key automation feature is the ability to trigger the sequence creation for electronic submissions with a single click. This action generates a notification in the EXTEDO pulse publishing app, informing regulatory operations teams. The dossier information is then automatically pulled from previously created regulatory activities, and in combination with EXTEDO's DMS Hub, metadata and documents are automatically added, making the submission compilation process highly efficient and reducing manual effort. EXTEDO's extensive experience of over 25 years and partnerships with more than 35 regulatory authorities worldwide underscore the solution's credibility and effectiveness in ensuring rapid compliance with global regulatory changes.

Key Takeaways:

• Comprehensive Regulatory Compliance: MPDmanager is purpose-built to navigate the complexities of global regulatory compliance, specifically addressing IDMP and XEVMPD standards for managing product information in an ever-changing landscape.
• Integrated Master Data Management (MDM): The solution offers a comprehensive approach to master data management for regulated products, encompassing controlled vocabularies, core product data, and country-specific registered product information.
• Automated XEVMPD/IDMP Compliance: It features integrated Controlled Vocabulary (CV) management with SPOR vocabularies, ensuring that all data is inherently XEVMPD and IDMP compliant, which is critical for international regulatory submissions.
• Efficient Core Product Data Reuse: The "core product" concept serves as a country and region-independent corporate template, enabling the efficient reuse and adjustment of existing data to generate country-specific registration information, thereby minimizing redundancy and potential errors.
• Streamlined Registration Workflow: The platform simplifies the creation and management of medicinal product registrations, allowing users to easily add specific data using various input methods and leveraging existing core product information.
• Proactive Activity and Deadline Management: MPDmanager supports the planning of multiple activities for products, integrates warnings for upcoming deadlines, and links activities to change requests, fostering a proactive approach to regulatory compliance.
• Automated Electronic Submission Compilation: A significant feature is the automation of electronic submission sequence creation, which notifies regulatory operations teams and automatically compiles dossiers with metadata and documents, drastically reducing manual effort and improving submission accuracy.
• User-Friendly and Customizable Interface: The system provides an intuitive interface with customizable columns, individual filtering, quick access options (favorites, tags), and advanced search capabilities, enhancing user productivity and data accessibility.
• Robust Data Search and Filtering: Users can perform advanced searches and apply property filters to quickly pinpoint specific information, such as planned marketing authorization applications based on country or procedure type, facilitating targeted data retrieval.
• Collaborative Data Sharing: The platform allows for the export of information to Excel and the sharing of saved searches or tags with colleagues, promoting collaboration and consistent data access across teams.
• Graphical Data Visualization: Records can be displayed in a graphical view within the main panel, offering alternative perspectives for data analysis and reporting, which can aid in understanding complex relationships.
• Industry Expertise and Trust: EXTEDO's extensive experience (over 25 years) and established relationships with more than 35 regulatory authorities worldwide underscore the solution's reliability and its ability to meet stringent regulatory demands.

Tools/Resources Mentioned:

• MPDmanager: EXTEDO's Master Data Management solution for regulated products.
• CARA: The underlying platform powering MPDmanager.
• EXTEDO pulse platform: The integrated platform of which MPDmanager is a part.
• EXTEDO pulse publishing app: Used for notifications regarding upcoming electronic submissions.
• EXTEDO's DMS Hub: Utilized for pulling dossier information, metadata, and documents for submissions.
• SPOR vocabularies: Standardized vocabularies used for IDMP and XEVMPD compliance.

Key Concepts:

• IDMP (Identification of Medicinal Products): International standards developed by ISO for the unique identification of medicinal products, essential for global regulatory compliance and data exchange.
• XEVMPD (Extended EudraVigilance Medicinal Product Dictionary): A European Medicines Agency (EMA) standard for submitting and managing medicinal product information within the EU.
• Master Data Management (MDM): A process that ensures consistency and control over an organization's core data, providing a single, accurate, and authoritative source of truth for critical business entities like products.
• Controlled Vocabularies (CVs): Standardized sets of terms or phrases used to ensure consistency, accuracy, and interoperability in data entry, retrieval, and regulatory submissions.
• Core Product: A foundational, country and region-independent template for product master data, designed to be reused and adapted for various country-specific registrations.
• Registered Product: Country-specific data pertaining to planned or registered products, built upon the core product information and tailored for local regulatory requirements.
• Regulatory Information and Activity Management: Systems and processes designed to manage all information, documents, and activities related to regulatory submissions, approvals, and ongoing compliance for regulated products.

Examples/Case Studies:

• The video illustrates how property filters can be used to identify specific information, such as "all planned marketing authorization applications in specific countries or according to their procedure type."
• It demonstrates the efficiency of creating new registration information by "reusing and adjusting existing core product information."
• The system facilitates planning "several activities for one or multiple products," with integrated "warnings" for upcoming deadlines.
• A key example of automation is the "sequence creation with a simple click on the button" for electronic submissions, which then "Auto created upon confirmation of the received task," pulling dossier information and automatically adding metadata and documents.