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FRANKFURT AM MAIN,
March 18, 2013 /PRNewswire/ -- LORENZ Life Sciences Group posed the question "Do you know the value of your xEVMPD data?" at the EuroMeeting held in
Amsterdam, Netherlands on
March 4 – 6, 2013.
IntroductionThe introduction of the xEVMPD standard has major implications for applicants and holders of European Union marketing authorizations, who are required to electronically register each of their approved and pending medicinal products with the EMA in detail. The registration includes all active ingredients and excipients as well as their manufacturers, any varying local substance names, the packaging sizes, quantities, MedDRA codes, ATC codes, administration routes, and the current SPC in the local language.
In response to this new standard, LORENZ has developed drugTrack™ EVMPD, an e-submissions solution specifically tailored to the new EMA requirements. It is available as a stand-alone package to manage xEVMPD submissions, but crucially it is also conceived to work seamlessly with LORENZ drugTrack regulatory lifecycle software.
Track & control your dataAt the core of drugTrack EVMPD is a wizard for entering the data and for creating correctly formatted xEVPRM messages. Existing submission data can be easily imported from typical information sources, such as Excel spreadsheets, and then managed in the new system.
The built-in messaging management function includes a "second pair of eyes" rule requiring a second person in the organization to approve any system-generated message before it is sent to EMA, and the software also tracks all replies. It will also send email alerts to the user with reminders 120 days in advance of pending deadlines. By capturing every single step in the submission process, drugTrack EVMPD can generate a perfect audit trail report on every submission and every change.