LORENZ Chosen by EMEA for Pilot eCTD Reviewing System
GUILDFORD, UNITED KINGDOM, Dec. 9th 2003: LORENZ has announced that it was chosen by the European Medicines Evaluation Agency (EMEA) to participate in a pilot phase to introduce eCTD reviewing capability at various authorities within the European Union. This followed a tender issued by the EMEA in which certain core functionality was defined as well as the overall direction.
"We are delighted to participate in this pilot," says Wolfgang Witzel, President & CEO of LORENZ Life Sciences Group. "We have been committed to reviewing systems for electronic submissions since the early nineties, and our flagship product docuBridge has inherited this unrivalled experience."
"The pilot phase was designed to provide reviewers at various authorities with hands-on experience. The EMEA is already receiving eCTDs and in order to continue to participate in the global discussions, we now have to gain an understanding on what is required to review such a submission," says Hans Georg Wagner, Head of Unit for Communications and Networking at the EMEA. "The speed in which we are moving also underlines the EMEAís commitment towards the eCTD."
In Europe, docuBridge is already being used by authorities such as the German Federal Institute for Drugs and Medical Devices and the Slovenian Agency for Medicinal Products. The installation and introductory training was performed at EMEA in November 2003 and subsequent implementation at additional European authorities has been scheduled for the coming months.
LORENZ remains committed in providing best-of-breed solutions to both industry and agency, the experience from both is helping to shape the future product development. The rapid implementation and training methodology helps authorities and companies alike in reaching productivity fast.