DRUG DISCOVERY AND DEVELOPMENT 21
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. Tis 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. Te 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.
Clarity that won’t drift away
The Olympus IX81-ZDC2 Z-Drift compensation system for automatically maintaining accurate focus.
For further information please visit:
www.microscopy.olympus.eu,
microscopy@olympus-europa.com
Circle 21 or ✔ at
www.scientistlive.com/eurolab
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