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Slovenian Agency for Medicinal Products chooses docuBridge

Nov2002

29

LJUBLJANA, SLOVENIA: In a move that will equip the authority with a complete submission management solution, the Slovenian Agency for Medicinal Products has chosen docuBridgeƆ to manage and review electronic submissions - including submissions using the CTD/eCTD format. This was the result of a Europe-wide tender.

“Our aim was to improve the effectiveness in our workflow processes for today and the future, thereby shortening the time needed for a new drug submission. This included in particular the review process, archiving, project management and our ability to exchange documents and data with EU systems such as EudraTrack,” says Dr. Vesna Koblar, Counsellor to the Government and in charge for managing the project. “In our evaluation, docuBridge was highlighted as being the best solution for our needs that could help us achieve all of our objectives.”

“The Slovenian Agency for Medicinal Products is taking a lead role in implementing and resolving the technological challenges set by EU guidelines and directives,” says Prof. Dr. Stanislav Primozic, Director of the Agency for Medicinal Products. “EU compliance and our ability to exchange information with EU authorities are key issues to any activities we undertake. The new IT support will add to the efficiency and transparency of our drug regulatory procedures.”

“We are delighted to have the Slovenian Ministry of Health choose our product. Providing complete solutions to both industry and authority gives us a unique standpoint from which to develop applications that will incorporate the challenges on both sides,” says Wolfgang Witzel, CEO of LORENZ Life Sciences. “The decision by another authority to select us as their supplier of choice underlines our commitment in providing state-of-the-art reviewing tools.”

The tender process was supported by the Delegation of the European Commission and evaluated on the basis of product functionality, cost and productivity. The objective is to improve the overall workflow procedures of the regulatory agencies and shorten the time period needed for a new drug submission.

The Slovenian Agency for Medicinal Products currently operates a traditional paper-based process. This takes time and requires significant archiving space. The exchange of relevant information with other drug regulatory agencies of the EU Member States will also be improved by implementing new electronic tools.

To improve the processes and to adhere to the guidelines within the EU requires investments in technology and in training agency staff.