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HALMED introduced 1.1 million € worth EU IPA 2009 project “Preparation for eCTD and implementation of digital archive information system

19.09.2014

The Agency for Medicinal Products and Medical Devices of the Republic of Croatia (HALMED), together with the project partners AAM Consulting and Ericsson Nikola Tesla, introduced on Tuesday, 16 September 2014 the results of the project "Preparation for eCTD and implementation of digital archive information system”. The ceremonial presentation took place at the Ericsson Nikola Tesla Company’s premises in Zagreb. This project that approaches HALMED towards the ideal "Paperless office”, is 1.120 000 € worth and is financed by the European Commission through the IPA 2009 programme.

The opening speeches were held by the Deputy of the Minister of Health, Prim. Marijan Cesarik, MD, MSc, Ms Mirella Rašić, Head of the Office for Political Information and Analysis at the EC Representation in Croatia, Viola Macolić Šarinić, MD, PhD, the Head of HALMED, Gordana Kovačević, MSc, the president of Ericsson Nikola Tesla d.d. and Gábor Kornai, PhD, the president of AAM Consulting.

Viola Macolić Šarinić, MD, highlighted in her opening speech that due to thorough and prompt preparations for the EU accession, HALMED is recognised today as a quality partner in the European regulatory network and concluded: "This project indeed justifies our high expectancy and offers HALMED the necessary support in preparation for the functioning in the integrated European regulatory space by upgrading the quality and efficacy of our work. Therefore this project is very important not only for HALMED, but also for the process of medicines authorisation in Croatia, as well as for our citizens as end users of medicines and medical devices.

The Deputy of the Minister of Health, Prim. Marijan Cesarik, MD, emphasized the importance of this project for HALMED as regulatory agency for medicines and the benefit of the project that could be monitored long term and used in the future. In addition, he emphasized that there should be more such successful projects with achieved results and he hoped that HALMED would be able to use even more EU funds through structural and investment funds.

The president of Ericsson Nikola Tesla, Gordana Kovačević, MSc, emphasised in her speech: "It is our pleasure to establish an excellent cooperation with HALMED as an important player in the Croatian Healthcare system. We have testified in this project, HALMED’s great professionalism and competence as well as a strong motivation to achieve business excellence and HALMED proved to be an excellent partner.”

Mirella Rašić from the EC Representative Office in Zagreb emphasized that the health is one of the key EU priorities and added: "These projects, even though technical in their nature, represent further steps in associating Croatia with other EU Member States. We face the challenges together and must go on with our cooperation.”

The results of the project were presented by the HALMED representatives Arian Rajh and Maja Lovrek and Tiana Pribanić from Ericsson Nikola Tesla and Ratko Gospodnetić, the representative of AAM Management Information Consulting Ltd.

The project has been carried out through two contracts; AAM Consulting carried out the 280 000 € worth contract "The analysis of business processes and upgrading of the Agency for Medicinal Products and Medical Devices”, whereas Ericsson Nikola Tesla has been trusted with the 839 999 worth contract "Digital archive information system of the Agency for Medicinal Products and Medical Devices”.

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HALMED introduced 1.1 million € worth EU IPA 2009 project “Preparation for eCTD and  implementation of digital archive information system
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