MINISTARSTVO ZDRAVLJA REPUBLIKE HRVATSKE [ MOH RC - HR ]

Ksaver 200a 10000 ZAGREB - Croatia

Md Dunja Skoko-Poljak

Involved in the following projects during the 3rd programme

3rd Health Programme (2014-2020)
Good Practices for demonstrating safety and quality through recipient follow-up [Euro-GTP II]
The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective impleme...
The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective implementation.
The outputs of this project will provide tools for assessing and verifying the quality, promote safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly to the implementation of novel T&C preparation processes and clinical indications, but also to the need of retrospective studies where weaknesses or insufficient safety data currently exist.
Recommendations will be forwarded to Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), as the main actors in the process of validation and designing T&C preparation processes and patient follow-up according to a clinical indication.
This project aim to define the threshold of novelty, including definition of the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed. The scope and extent of the recommended studies will be determined on the basis of a risk based approach performed taking into account factors such as the novelty of the product/preparation process/clinical indication, and its technical complexity.
A T&C Database of products, preparation procedures, clinical applications and their current status of authorisation and implementation will be established, working as a starting point for determining the ‘novelty’ of processes/therapies by TEs and ORHAs, and allowing the use of established processes/therapies by any centre that strictly follows the same procedure/clinical procedure/indication.
This project also aims to define a “GTP’s management model” that could provide impetus for future standards harmonisation and promotion, and allow the establishment of European accreditation and training programs for TE.
Start date: 01/04/2016 - End date: 31/03/2019

Call: Call for Proposals for Projects 2015
Topic: Common assessment methodology on quality, safety and efficacy of transplantation therapies
3rd Health Programme (2014-2020)
facilitatinG the Authorisation of Preparation Process for blood and tissues and cells [GAPP]
GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to a...
GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissues establishments (BEs and TEs). Particular attention will be devoted to innovative processes that might come up taking advantage of the work developed in previous EU funded projects/actions. This Joint Action will clearly contribute to the implementation of Union legislation in the fields of human tissues and cells, blood, providing tools and training to increase harmonisation of those MS activities that regulate the areas of blood transfusion, transplantation of tissues and cells and assisted reproduction, in strong abidance with art 4.5 of Annex I of Regulation 282/2014. These are fields of healthcare that involve a considerable amount of movement of donated substances of human origin between MS and also movement of citizens between MS for treatment, particularly in the field of assisted reproduction. The aim of the action is to prepare a “Good Practice Guidelines to authorisation and preparation process in blood, tissues and cells” and its three technical annexes respectively on i) authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in three part blood, tissues and cells, and reproductive tissues and cells); ii) assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA; iii) assessing clinical data as part of PPA. In addition to this it will be built a model and a tool to facilitate sharing of information among European Union Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.
Start date: 01/05/2018 - End date: 30/04/2021

Call: Joint Actions 2016
Topic: Authorisation of preparation processes in blood and tissues and cells
3rd Health Programme (2014-2020)
Joint Market Surveillance Actions on medical devices intended to be re-sterilized focusing on information in the Instruction for use and validation data necessary for the re-sterilisation by the user [COENJA2014]
Member states (MS) are reinforcing their market surveillance of medical devices, in particular by improving their coordination, i.e. for performing a joint market surveillance action including appropr...
Member states (MS) are reinforcing their market surveillance of medical devices, in particular by improving their coordination, i.e. for performing a joint market surveillance action including appropriate checks on the characteristics of products placed in the European Market. This joint action (JA) includes further development and expanding the coordination between MS, joint inspections by the Competent Authorities (CAs) shall be part of the project.
This Joint Action of European CAs will improve the transparency in the medical device market regarding compliance of medical devices to be reprocessed. It shall be investigated if the instruction for use (IFU) of medical devices intended to be re-used and resterilized conforms and contains all necessary information for safe and adequate re-processing. This will also allow an actual overview of the market related to these products and detecting deficiencies regarding re-processing posing a serious hazard to safety.
The market surveillance JA also contains additional elements, besides review of the IFU and sections of the technical documentation, such as inspections of manufacturers and other relevant actors. The outcome may also result in joint enforcement actions by the respective MS to be coordinated if needed and adequate. Meetings shall support harmonizing the processes to achieve a uniform action and to discuss and publish the final report.

Start date: 01/11/2015 - End date: 30/04/2017

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: Coordination and resource sharing between Member States
3rd Health Programme (2014-2020)
Vigiliance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation [VISTART]
The aim of this Action is to support EU Member States (MS) in developing and strengthening their capacity for monitoring and control in the field of blood transfusion and tissue and cell transplantati...
The aim of this Action is to support EU Member States (MS) in developing and strengthening their capacity for monitoring and control in the field of blood transfusion and tissue and cell transplantation. 7 core work-packages (WP) have been defined. WP4 will explore commonalities between vigilance reporting in these fields, identifying opportunities for harmonising procedures. WP5 will increase the sharing of vigilance information of didactic value in order to achieve higher standards of quality and safety across blood, tissues and cells, as well as defining regulatory principles for short and long term follow up of recipients of blood, tissues and cells that have been prepared with newly developed and validated processes. WP6 will focus on the development of common Inspection Guidelines for EU Competent Authorities responsible for the inspection and authorization of blood and tissue establishments. The main objective is the identification of a common framework for the conduct of inspections of blood and tissue establishments, developing a common approach with sharing of procedures across MS. The educational profile, basic competencies and specific skills required by MS for the respective inspectors in these fields will be defined in WP7. This action will include a number of initiatives aimed at increasing the interaction between inspectors from different MS including inspector training, a framework for joint inspections by multi-MS teams (WP8), a pilot for regional inspections and the creation of an inter-MS (WP9) inspection system auditing programme. The impact of these activities will be greatly increased by virtue of their conduct across the fields of blood, tissues and cells and ART. Greater inter-MS circulation of tissues and cells will also be facilitated by this action through support for the harmonised implementation of the Single European Code (WP10) and its associated compendia of tissue establishments and tissue and cell products.
Start date: 10/10/2015 - End date: 09/02/2019

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: Blood transfusion and tissue and cell transplantation Joint Action