From 2nd July 2012, pharmaceutical organisations marketing and selling drugs in Europe have no choice but to comply with strict new requirements concerning the collection, reporting, coding and evaluation of medicinal product data, as part of the industry's latest measures to minimise the impact of adverse reactions to drugs (Fig.1). Specifically, organisations must adhere to the EudraVigilance Medicinal Product Dictionary (EVMPD).
"CSC stands apart as the one solutions provider to offer complete managed-service systems that ensure companies' readiness to meet the EVMPD mandate. The timelines are too tight for companies to wait for fully integrated regulatory information management tools to come on the market, let alone have them implemented and validated in time. The collection planning and the actual collection of company data have to start now, and CSC is prepared to host, manage and deliver EVMPD messages for clients," says CSC Life Sciences director Adam Sherlock.
CSC tailors submission strategies to suit clients' needs and organisational structures. Whether a pharma company's management of its regulatory information is centralised or decentralised, CSC can create the most efficient way of getting the information together for EVMPD messages.
Its EVMPD services are complemented with TRS Tracker, a robust, fully integrated regulatory information management solution. With a powerful search and reporting capabilities, TRS Tracker delivers users a holistic view of vital product information. In addition, CSC is working to ensure that TRS Tracker 5.2 will allow users to manage and transmit EVMPD submissions. This capability will be made available in the summer of 2012.
CSC's services include: environmental analysis and data mapping - working with companies to map where data are held, and assessing how the information relates to the EVMPD format; gap analysis and data validation - helping to identify whether any data elements are missing, and if validation is required validating it to pre-agreed standards; collection and collation - using the company's own hosted tool that has been designed specifically for both the EVMPD and the EudraVigilance product report message (EVPRM) format for communicating with the agency to get companies' data ready at the right time and in the right format; quality assurance procedures and project governance - procedures are customised to meet a client's quality assurance requirements. Quality checks are built in to ensure accuracy and compliance, and CSC's project governance structures let clients see progress and access reports throughout; managing the life cycle through change - assessing whether a client's business processes can respond to changes in product information that would result in new EVPRMs. At the same time, CSC can continue making updates to keep EVMPD records compliant.
Meanwhile Freyr's EVMPD is an easy-to-use, hosted, on-demand web-based solution for information management with state-of-the-art navigation and user interface components. The application was created keeping in mind the tedious data entry needs of large number of data elements required for complying with EVMPD requirements. The application supports modular data entry screens based on submission components. This enables granular authoring and component level data entry validation. Data entered as components can be validated in modular fashion without having to wait for all the submission components to be completed.
Freyr's EVMPD application guides users with context-sensitive helpful hints making the data entry process simple and error free. Reference look-ups are provided for appropriate data elements. It checks for data entry errors and all the required business rule validations as specified by the EMA. The built-in validation engine checks for message integrity (technical checks) and scientific validation of data, thus ensuring a 100% EMA compliant EVMPD XML file. Freyr EVMPD has comprehensive security and workflow features supporting authoring, review, approve, publish and archival processes.
It also allows automated updating of EMA assigned EV code to local code mapping and enables EVMPD management for future updates and communication to EMA. The application tracks the changes and generates the updated delta EVMPD compliant XML file.
Overall, the key benefits of Freyr's solution are being web-based and on-demand, an out-of-the-box solution, minimal start-up costs, and guaranteed compliance with EMA guidelines and business rules.
New from Liquent is its XEVMPD Educational Series and Data Assessment tool. Both are designed to assist in complying with the 2 July deadline.
The XEVMPD Educational Series is designed to educate internal personnel about the requirements for XEVMPD. The sessions consist of five recorded modules, for a total of four hours of training, focused on areas such as the understanding of why EMA is requiring XEVMPD, recent announcements and timelines, and requirements for authorised products, approved substances, and development substances and products.
The XEVMPD Data Assessment tool will assist organisations in determining what data is needed for compliance and where the data is currently managed or tracked within the organisation.
Mission3 GlobalTrack GxPD also provides a comprehensive framework for xEVMPD and IDMP data. This framework allows for either data entry directly into GlobalTrack GxPD or pulling data easily into GlobalTrack GxPD from external systems. With this in mind, GlobalTrack GxPD means users are positioned for immediate xEVMPD needs while preparing for a long-term integrated international product dictionary (IDMP) solution.
Further, Mission3 GlobalTrack GxPD is a platform solution built on Microsoft SharePoint. With a platform approach companies benefit from a singular data platform where xEVMPD data is centralised and utilised by other applications such as business intelligence, reporting, regulatory tracking and planning, health authority correspondence, plus other life sciences line-of-business applications.
Seeing the need early for its customers' to support the EMA mandate, Mission3 already had key functions in GlobalTrack GxPD to support its near and long term goals with respect to the xEVMPD - functionality such as a robust data framework; a dynamic and compliant user interface; native integration to systems such as Documentum/FirstDoc, SAP and others; and a platform approach based on Microsoft SharePoint. Implementing a solution where data can be integrated will significantly increase compliance and make teams 30 per cent more efficient than re-keying data.
Virtify EVMPD is also designed with 2nd July in mind. It can run in-house or be hosted as a standalone product or as a module to the Virtify Global Labelling product suite. Like all other Virtify products, Virtify EVMPD is built on the company's structured content platform, an open, extensible architecture that uses common infrastructure and business components that allow users to operate at the element and fragment level to increase efficiency and flexibility dramatically.
Virtify EVMPD offers a rich set of features, including: an easy-to-use web-based interface for managing EVMPD submissions; the ability to do bulk uploading of all coded EVMPD data through Excel spread sheets as a convenient alternative to manual data entry through web forms; and the ability to create the master Printed Product Information attachment by uploading each document into the system in either Word or PDF format. The system will then assemble it into the EVMPD file to be submitted. Printed Product Information already aggregated and assembled into a file outside the system can also be uploaded through Virtify EVMPD.
In addition to Virtify's EVMPD software, the company offers a range of relevant services such as labelling and validation.
Finally Teva, the largest generic drug manufacturer in the world, will use INFOTEHNA eMPDExpert to submit its entire European product portfolio information to EMA by the regulatory deadline.
INFOTEHNA eMPDExpert, the newest member of INFOTEHNA myPharmaExpert suite, was the solution that received top ranking after weeks of detailed evaluation, including shaping a very clear implementation path by the company's life sciences professional services team.
eMPDExpert features: structuring and collecting XEVPRM data; creation of XEVPRM; electronic submission; user-friendly interface; drop-down lists; one-time input of information; direct submission; and re-use of information and documents.
