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HALMED is implementing a one year IPA project “Preparation for eCTD and implementation of digital archive information system”


From 2 September 2013, the Agency for Medicinal Products and Medical Devices (HALMED) has been implementing a one year project "Preparation for eCTD and implementation of digital archive system” from the IPA 2009 TAIB project. The project has been funded by the European Union and co-financed by HALMED. The project is led by Mr Denis Matas from the Central Finance and Contracting Agency (CFCA) and Assisstant Professor Arian Rajh, PhD from HALMED.

The project consists of two contracts. The implementation of the first contract started in September 2013 with the aim to analyse all HALMED’s business processes and create a strategic plan. HALMED’s external partner in implementation of this part of the project is is the company AAM Management Information Consulting Ltd, and the team leader is Ratko Gospodnetić, B.SC. 15 processes and 7 work flow have been analyised and approved by March this year, 54 processes have been analysed and are awaiting approval and 20 processes and 40 work flows with corresponding case studies have yet to be analysed and modelled by the end of the project. The ISO standard for modelling business processes ISO/IEC 19510 Information technology - Object Management Group Business Process Model and Notation (BPMN) and the controlled wordbook of terms - objects of process models have been used in analysing and modelling.

The implementation of the second contract started in December 2013 with the aim to establish a programme system for HALMED’s business content management, based on the IBM FileNet platform. . The company Ericsson Nikola Tesla d.d. and the team leader Mr Žarko Videc are responsible for implementation of the contract. The system will comprise of the module for documentation management, module for record management, module for standard operative procedure management and module for introduction/implementation and content migration according to the ISO standard for open archive information systems. Business processes analysed according to the first contract will be will be managed by means of business process managing model. In addition to the creation of these modules, the focus of the project is on integration of business, office and archive applications with the system of business content management, in order to achieve a maximal operating flexibility and consistency in HALMED’s work. Therefore, the IPA project follows on the results of previous and on-going ALMED’s projects - creation of the National Medicines Registry, subsystem of medicines quality control, OLIMP subsystem, Extranet website, subsystem for eCTD and NeeS dossier handling, subsystem of office file registry and subsystem of archiving book. By March 2014 specifications of user’s requests were completed within the second contract and the test environment was established.

The IPA project is an important strategic project facilitating the maintenance of the HALMED’s business excellence level. The presentation of the project results is planned for the beginning of September 2014.