Helping Companies Comply with the EU’s EVMPD Legislation

With the EMA’s new EudraVigilance Medicinal Product Dictionary (EVMPD) requirements deadline of July 2, 2012 rapidly approaching, companies are working hard and evaluating strategies to make this submission deadline. The Virtify EVMPD software solution is designed to enable organizations to address this issue efficiently.

Virtify EVMPD can run in-house or can be hosted as a standalone product or as a module to the Virtify Global Labeling product suite. Like all other Virtify products, Virtify EVMPD is built on Virtify's Structured Content platform—an open, extensible architecture that uses common infrastructure and business components that allows 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.
• 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.
  • For customers that use Virtify EVMPD in conjunction with the Virtify European Labeling (EUL) module, Product Information documents will already be in the system and can be pulled in simply by referencing them.  
• The ability to store and update companywide vocabularies and substance listing along with the controlled terminology published by EMA. 
• Recording of all exchanges with EMA so that the submission history is comprehensively tracked. 
• A configurable workflow engine that allows for customer specific workflows to be defined as per their internal process of creation, review, approval and submission of EVMPD data.
• Validation of EVMPD submission against schema and set of business rules published by EMA, ensuring full compliance. 

Many companies that need to comply with the new EVMPD legislation are actively evaluating software and services to assist them to do so. In addition to Virtify’s EVMPD software, the company offers a range of relevant services as well.  Virtify is a well-established service provider to the pharmaceutical industry offering labeling, validation, and other similar services to clients’ regulatory affairs and other related departments. Virtify EVMPD software solution can be utilized independently or in combination with Virtify professional services. This gives companies the flexibility to choose a solution combination that best meets their organization-wide requirements.

Virtify EVMPD software is a new module available as to the Virtify Global Labeling suite. For those customers that already are using Global Labeling, they will enjoy the ability  to more easily meet mandates such as EVMPD by leveraging data currently organized and aggregated  as part  of normal label creation and maintenance activities performed in the Labeling product.  In addition the product offers other valuable capabilities such as:

• Inter- and intra- linking of content— Comprehensive content linking accelerates labeling operations by maximizing content reuse while simultaneously improving consistency, quality and minimizing translation costs.
• Integrated translation management—Provides translation tracking and status reporting for all 24 EU languages.
• Multi-layer versioning—Provides version layers for individual fragments, as well as for overall submissions, eliminating the need to track fragment changes separately.