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SOURCE LORENZ Life Sciences Group
FRANKFURT AM MAIN, Germany, 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.
The 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 data
At 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.
Do you know the value of your data?
drugTrack EVMPD works flawlessly as a stand-alone solution. Yet the software will yield significantly more added value when purchased as part of drugTrack PRO which will allow you to re-use your xEVMPD data for other important regulatory information tasks.
Manage your full regulatory lifecycle
The system presents an opportunity for companies to manage all regulatory affairs information with a single system, saving both cost and time in the process. LORENZ drugTrack PRO can use a company's accumulated data to track the entire regulatory lifecycle on both the national and European levels, thus eliminating the time and cost of maintaining two parallel tracking systems.
Identify the impact of changes in your product composition
In addition, drugTrack offers cost-saving features such as batch reporting. When a variation such as a change in a supplier address arises, drugTrack can generate a report of all registrations affected by the change, market by market, and generate the variation reports to all of the relevant national authorities.
Plan your regulatory strategy
The entire drugTrack system was originally developed together with a pharmaceutical company to satisfy their regulatory tracking needs. It provides a level of security and complexity that the traditional range of spreadsheets, calendar entries and handwritten notes simply cannot. In that scenario, spreadsheet data can be changed accidentally with no control, multiple versions of the same sheet can circulate at the same time, and there is no consistent system for reminders and deadline alerts. drugTrack integrates all of this into a single database system where every step is tracked and remains transparent. Marked entries highlight where changes have been made between versions. And notifications and reminders ensure that no deadline is missed.
The LORENZ drugTrack system will also support the global ISO Identification of Medicinal Products (IDMP) format when it comes into force.
About LORENZ Life Sciences Group?
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. As the number one supplier of submission management systems in the world, as well as the largest supplier of eCTDs for U.S., European and Japanese submissions in the world, LORENZ is the technological market leader. With over 280 installations in over 25 countries, LORENZ has built a reputable customer base. For further information or to arrange a demonstration of drugTrack EVMPD or drugTrack PRO, please contact LORENZ.
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