LORENZ' Response to New EU PV Legislation - Regulation No. 1235/2010 and EVMPD

FRANKFURT AM MAIN, Germany, Nov. 2, 2011 /PRNewswire/ -- LORENZ customers and business partners have successfully completed the first workshop on the new Requirements of Article 57(2) of Regulation (EC) 726/2004 and its impact on the industry. This marked the start of the LORENZ Special Interest Group for EVMPD – XEVPRM.

One of the hot topics in the regulated market space of drug registration are the Requirements of Article 57(2) of Regulation (EC) 726/2004. Since the EU has mandated the European Medicines Agency (EMA) to build a database for all registered product information within the European Union, many organizations are discussing and planning how to cope with the challenge to supply relevant data within a very aggressive time schedule. The legislation is effective and mandatory as of 2nd July 2012. A quote from the EMA website reads: "The legislation is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of European Union marketing authorizations."

With this in mind, a strategic group of LORENZ customers and business collaborators came together on 24th October 2011 at LORENZ Headquarters in Frankfurt, Germany. In this workshop the complexity of the undertaking became clear, and the challenging timelines were reviewed.

"The data model, ease of use and proven track record of supplying a data entry platform will be key for our customers and coworkers", says Wolfgang Witzel, President of LORENZ Life Sciences Group. "There are several facts that we have to accept. Firstly, the draft specification has only been available since 1st September 2011. Secondly, further guidance is outstanding and questions on the specification still needs to be answered. Thirdly, example messages are outstanding. Fourthly, vocabularies are outstanding. And finally, on the technology side, both the Gateway and EVWeb supplied by EMA are not ready. This is a huge challenge for industry."

"As a result, LORENZ believes this has to be planned carefully and adapted as the specification and guidance becomes more mature. It also means that any organisation offering a final solution today cannot be providing a serious offer and the buyer will possibly be paying a premium," Wolfgang Witzel continues.

Raoul-A. Lorenz, CEO of LORENZ Life Sciences Group, added, "LORENZ has the track record of being the most innovative provider of quality software and related services for e-regulated processes in the Life Sciences industry. As a result, LORENZ too will look into options in providing a validated product for this important process as well.  The ultimate goal is to comply to the future ISO IMPD standard, recognizing that the XEVPRM is an interim standard."

Further information about the meeting, progress of work and timelines will be distributed and can be accessed via LORENZ ID as of December 2011.

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 200 installations in 25 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.

SOURCE LORENZ Life Sciences Group

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