20 DRUG DISCOVERY AND DEVELOPMENT
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. Tis 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. Te application was created keeping in mind the tedious data entry needs of large number of data elements required for complying with EVMPD requirements. Te application supports modular data entry screens based on submission components. Tis 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. Te 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
EVMPD solution on cloud S
arjen Systems’ compliance offering is PVNET EVPRM, a solution that encompasses all the requirements and creates a fully compliant XML
for submission of mandated product data. PVNET EVPRM is also available on cloud and has
provision for importing data from XML and XLS. The company says that this approach provides customers with significant protection in their investment and helps mitigate risk associated with the near term EVMPD challenge. Key functions of Sarjen’s solution include: a robust
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data framework which supports extended EVMPD and structured substance information (SSI); a dynamic user interface; multiple data entry mechanism with specific alternatives for products with multiple MAHs; works on platform approach based on cloud as well act as a standalone application; in-built capability of supporting list of controlled vocabularies which is used to encode the product/substance information, such as ATC codes, routes of administration and pharmaceutical forms; creates zipped package of compliant XML and related attachments which is ready to be transmitted
via the EudraVigilance gateway; batch import and processing; and an audit trail of all activities done by all users. The company also provides services for creating
XEVPRM standardised XML, which is also technically compliant for submission to the EudraVigilance system. The company says its three-stage strategy - collect
required information from the client, convert it to EVPRM schema compliant XML and zip formats, then deliver a zip package to the client - is extremely straightforward.
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. Te 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.
Te XEVMPD Educational Series is designed to educate internal personnel about the requirements for XEVMPD. Te 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.
Te XEVMPD Data Assessment tool will assist organisations in determining what data is needed for
“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.”
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