TY  - JOUR
AU  - Marinković, Valentina
AU  - Bekcić, Stana
AU  - Pejović, Gordana B.
AU  - Šibalija, Tatjana V.
AU  - Majstorović, Vidosav D.
AU  - Tasić, Ljiljana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2736
AB  - Purpose-The purpose of this paper is to explore the good practice (GxP) and standardised management system integration within total quality management (TQM) paradigm in pharmaceutical sector in Serbia. Also, the impact of all interested parties on quality management has been assessed. Design/methodology/approach-The cross-sectional study was performed, including different stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma representative offices, as well as national regulatory authority. A survey instrument was developed, consisted of 16 questions, which were organised into four groups: questions in relation to implementation of ISO 9001, implementation of good distribution practice/good manufacturing practice, integration of management systems, and impact on TQM and business excellence. Total number of participants was 121. Findings-Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support companies to improve business environment and management sustainability, but this survey indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia. Although pharmaceutical companies has faced many challenges in recent years, the survey revealed high level of confidence in quality management systems, as well as the necessity of various management systems integration. Originality/value-The perception of TQM by the experts in pharmaceutical companies and regulatory authority is wider than the common TQM definition. From pharmaceutical point of view, TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate integration process towards TQM and business excellence.
PB  - Emerald Group Publishing Ltd.
T2  - TQM Journal
T1  - An approach to TQM evaluation in pharma business
VL  - 28
IS  - 5
SP  - 745
EP  - 759
DO  - 10.1108/TQM-10-2015-0134
ER  - 

@article{
author = "Marinković, Valentina and Bekcić, Stana and Pejović, Gordana B. and Šibalija, Tatjana V. and Majstorović, Vidosav D. and Tasić, Ljiljana",
year = "2016",
abstract = "Purpose-The purpose of this paper is to explore the good practice (GxP) and standardised management system integration within total quality management (TQM) paradigm in pharmaceutical sector in Serbia. Also, the impact of all interested parties on quality management has been assessed. Design/methodology/approach-The cross-sectional study was performed, including different stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma representative offices, as well as national regulatory authority. A survey instrument was developed, consisted of 16 questions, which were organised into four groups: questions in relation to implementation of ISO 9001, implementation of good distribution practice/good manufacturing practice, integration of management systems, and impact on TQM and business excellence. Total number of participants was 121. Findings-Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support companies to improve business environment and management sustainability, but this survey indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia. Although pharmaceutical companies has faced many challenges in recent years, the survey revealed high level of confidence in quality management systems, as well as the necessity of various management systems integration. Originality/value-The perception of TQM by the experts in pharmaceutical companies and regulatory authority is wider than the common TQM definition. From pharmaceutical point of view, TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate integration process towards TQM and business excellence.",
publisher = "Emerald Group Publishing Ltd.",
journal = "TQM Journal",
title = "An approach to TQM evaluation in pharma business",
volume = "28",
number = "5",
pages = "745-759",
doi = "10.1108/TQM-10-2015-0134"
}

Marinković, V., Bekcić, S., Pejović, G. B., Šibalija, T. V., Majstorović, V. D.,& Tasić, L.. (2016). An approach to TQM evaluation in pharma business. in TQM Journal
Emerald Group Publishing Ltd.., 28(5), 745-759.
https://doi.org/10.1108/TQM-10-2015-0134

Marinković V, Bekcić S, Pejović GB, Šibalija TV, Majstorović VD, Tasić L. An approach to TQM evaluation in pharma business. in TQM Journal. 2016;28(5):745-759.
doi:10.1108/TQM-10-2015-0134 .

Marinković, Valentina, Bekcić, Stana, Pejović, Gordana B., Šibalija, Tatjana V., Majstorović, Vidosav D., Tasić, Ljiljana, "An approach to TQM evaluation in pharma business" in TQM Journal, 28, no. 5 (2016):745-759,
https://doi.org/10.1108/TQM-10-2015-0134 . .

TY  - CONF
AU  - Marinković, Valentina
AU  - Bekcić, Stana
AU  - Đorđević, J.
AU  - Tasić, Ljiljana
AU  - Stojković, Tatjana
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2682
AB  - Objectives: To assess current attitudes of urologists to „off-label“ prescribing
of BCG vaccine for high grade non-muscle invasive bladder cancer (NMIBC) and
carcinoma-in-situ (CIS), as well as to perform a pharmacoeconomic evaluation
of BCG vaccine manufactured by local pharmaceutical company. Methods: The
attitudes and experiences of urologists regarding „off-label“ use of BCG vaccine
for intravesical immunotherapy of bladder cancer, have been evaluated by using
non-probability snowball sampling technique and specifically designed question-
naire. Clinical, social, economic, ethical and regulatory factors have been included.
Snowball sampling has involved urologists from ten different hospitals in the
Northern, Central and Southern Serbia, greatly experienced in intravesical BCG
immunotherapy. Results: BCG is used for intravesical immunotherapy, and has
become the standard care for NMIBC and CIS. BCG therapy may reduce the risk of
tumour progression, appearing to be better in preventing recurrences compared to
chemotherapy, but with significantly more side effects. „Off-label“ use is the use
of a medicinal product for another indication, another patient group, another dose
or by another route of administration as indicated in the package insert. It was
noted that BCG was in the „off-label” use in a 50,0% hospitals which had a problem
with purchase of BCG for immunotherapy (regarding worldwide shortages). It was
estimated that there were 1095 patients with bladder cancer in Serbia per year. The
model according to which 18 vials of domestic BCG vaccine are used for immu-
notherapy per patient per year, projected the net budget savings of 593 862.30 € per year. Conclusions: This research could support the further clinical studies
of BCG vaccine of local manufacturer, for new indications (NMIBC and CIS). That
would enable lower costs per patient, higher quality, availability and the continuous
supply of immunotherapy.
PB  - Elsevier Science Inc
C3  - Value in Health
T1  - A prospective assesment of attitudes and experiences among urologists regarding off label use of bcg vaccine in Serbia
VL  - 19
IS  - 7
SP  - A497
EP  - A498
DO  - 10.1016/j.jval.2016.09.875
ER  - 

@conference{
author = "Marinković, Valentina and Bekcić, Stana and Đorđević, J. and Tasić, Ljiljana and Stojković, Tatjana",
year = "2016",
abstract = "Objectives: To assess current attitudes of urologists to „off-label“ prescribing
of BCG vaccine for high grade non-muscle invasive bladder cancer (NMIBC) and
carcinoma-in-situ (CIS), as well as to perform a pharmacoeconomic evaluation
of BCG vaccine manufactured by local pharmaceutical company. Methods: The
attitudes and experiences of urologists regarding „off-label“ use of BCG vaccine
for intravesical immunotherapy of bladder cancer, have been evaluated by using
non-probability snowball sampling technique and specifically designed question-
naire. Clinical, social, economic, ethical and regulatory factors have been included.
Snowball sampling has involved urologists from ten different hospitals in the
Northern, Central and Southern Serbia, greatly experienced in intravesical BCG
immunotherapy. Results: BCG is used for intravesical immunotherapy, and has
become the standard care for NMIBC and CIS. BCG therapy may reduce the risk of
tumour progression, appearing to be better in preventing recurrences compared to
chemotherapy, but with significantly more side effects. „Off-label“ use is the use
of a medicinal product for another indication, another patient group, another dose
or by another route of administration as indicated in the package insert. It was
noted that BCG was in the „off-label” use in a 50,0% hospitals which had a problem
with purchase of BCG for immunotherapy (regarding worldwide shortages). It was
estimated that there were 1095 patients with bladder cancer in Serbia per year. The
model according to which 18 vials of domestic BCG vaccine are used for immu-
notherapy per patient per year, projected the net budget savings of 593 862.30 € per year. Conclusions: This research could support the further clinical studies
of BCG vaccine of local manufacturer, for new indications (NMIBC and CIS). That
would enable lower costs per patient, higher quality, availability and the continuous
supply of immunotherapy.",
publisher = "Elsevier Science Inc",
journal = "Value in Health",
title = "A prospective assesment of attitudes and experiences among urologists regarding off label use of bcg vaccine in Serbia",
volume = "19",
number = "7",
pages = "A497-A498",
doi = "10.1016/j.jval.2016.09.875"
}

Marinković, V., Bekcić, S., Đorđević, J., Tasić, L.,& Stojković, T.. (2016). A prospective assesment of attitudes and experiences among urologists regarding off label use of bcg vaccine in Serbia. in Value in Health
Elsevier Science Inc., 19(7), A497-A498.
https://doi.org/10.1016/j.jval.2016.09.875

Marinković V, Bekcić S, Đorđević J, Tasić L, Stojković T. A prospective assesment of attitudes and experiences among urologists regarding off label use of bcg vaccine in Serbia. in Value in Health. 2016;19(7):A497-A498.
doi:10.1016/j.jval.2016.09.875 .

Marinković, Valentina, Bekcić, Stana, Đorđević, J., Tasić, Ljiljana, Stojković, Tatjana, "A prospective assesment of attitudes and experiences among urologists regarding off label use of bcg vaccine in Serbia" in Value in Health, 19, no. 7 (2016):A497-A498,
https://doi.org/10.1016/j.jval.2016.09.875 . .

TY  - JOUR
AU  - Bekcić, Stana
AU  - Kelecević, Nenad
AU  - Marinković, Valentina
AU  - Tasić, Ljiljana
AU  - Krajnović, Dušanka
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2437
AB  - Outsourcing is increasingly used by the vaccine manufacturers. When the manufacturing activities are outsourced, the contract manufacturer's Good Manufacturing Practice compliance needs to be confirmed through auditing. In the same way, when distribution is outsourced, the contract distributor's Good Distribution Practice compliance needs to be confirmed through auditing. The objective of this study was to develop an audit preparation tool for the pharmaceutical contract vaccine distributor and to validate its contents by using the Delphi method. Based on this, a tool was developed for the contract vaccine distributors. The Delphi method was used with a group of 14 experts from the pharmaceutical industry, authorities and university. The response rate in the Delphi questionnaire round was 100 %. The tool consisted of 33 quality items, out of which 29 (88%) achieved the pre-defined agreement rate level (>75%). The four quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert group suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good. The resultant questionnaire is ready to use. Developed the ready-to-use questionnaire based on critical factors evaluation, gives an objective picture of the possibilities of the potential partner and help organisations make quality decision on the selection of contract vaccine distributors. The contract vaccine distributor must be permanently controlled and analysed, so as to maintain the required quality and to keep low level of costs.
PB  - Assoc Pharmaceutical Teachers India, Bangalore
T2  - Indian Journal of Pharmaceutical Education and Research
T1  - Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor
VL  - 49
IS  - 3
SP  - 174
EP  - 182
DO  - 10.5530/ijper.49.3.2
ER  - 

@article{
author = "Bekcić, Stana and Kelecević, Nenad and Marinković, Valentina and Tasić, Ljiljana and Krajnović, Dušanka",
year = "2015",
abstract = "Outsourcing is increasingly used by the vaccine manufacturers. When the manufacturing activities are outsourced, the contract manufacturer's Good Manufacturing Practice compliance needs to be confirmed through auditing. In the same way, when distribution is outsourced, the contract distributor's Good Distribution Practice compliance needs to be confirmed through auditing. The objective of this study was to develop an audit preparation tool for the pharmaceutical contract vaccine distributor and to validate its contents by using the Delphi method. Based on this, a tool was developed for the contract vaccine distributors. The Delphi method was used with a group of 14 experts from the pharmaceutical industry, authorities and university. The response rate in the Delphi questionnaire round was 100 %. The tool consisted of 33 quality items, out of which 29 (88%) achieved the pre-defined agreement rate level (>75%). The four quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert group suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good. The resultant questionnaire is ready to use. Developed the ready-to-use questionnaire based on critical factors evaluation, gives an objective picture of the possibilities of the potential partner and help organisations make quality decision on the selection of contract vaccine distributors. The contract vaccine distributor must be permanently controlled and analysed, so as to maintain the required quality and to keep low level of costs.",
publisher = "Assoc Pharmaceutical Teachers India, Bangalore",
journal = "Indian Journal of Pharmaceutical Education and Research",
title = "Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor",
volume = "49",
number = "3",
pages = "174-182",
doi = "10.5530/ijper.49.3.2"
}

Bekcić, S., Kelecević, N., Marinković, V., Tasić, L.,& Krajnović, D.. (2015). Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor. in Indian Journal of Pharmaceutical Education and Research
Assoc Pharmaceutical Teachers India, Bangalore., 49(3), 174-182.
https://doi.org/10.5530/ijper.49.3.2

Bekcić S, Kelecević N, Marinković V, Tasić L, Krajnović D. Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor. in Indian Journal of Pharmaceutical Education and Research. 2015;49(3):174-182.
doi:10.5530/ijper.49.3.2 .

Bekcić, Stana, Kelecević, Nenad, Marinković, Valentina, Tasić, Ljiljana, Krajnović, Dušanka, "Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor" in Indian Journal of Pharmaceutical Education and Research, 49, no. 3 (2015):174-182,
https://doi.org/10.5530/ijper.49.3.2 . .

TY  - JOUR
AU  - Bekcić, Stana
AU  - Kelecević, Nenad
AU  - Marinković, Valentina
AU  - Tasić, Ljiljana
AU  - Krajnović, Dušanka
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1891
AB  - This paper discusses how a system approach to management can be used for the development and implementation of an integrated management system (IMS) in a company producing medicinal products. It is argued in the paper that approaches to the solutions of how to integrate management systems all require two elements: a conceptual model and a supporting methodology. Although a large number of models has been developed that could provide the basis for integration, development of methodologies to achieve fully integrated systems is still stagnating. This paper presents the IMS model that can be used to integrate the requirements of existing and upcoming standards in the pharmaceutical industry, followed by a discussion on the issue of the IMS methodology.
PB  - Assoc Pharmaceutical Teachers India, Bangalore
T2  - Indian Journal of Pharmaceutical Education and Research
T1  - Approach to the Integration of Management Systems in a Pharmaceutical Organization
VL  - 47
IS  - 3
SP  - 19
EP  - 25
DO  - 10.5530/ijper.47.3.4
ER  - 

@article{
author = "Bekcić, Stana and Kelecević, Nenad and Marinković, Valentina and Tasić, Ljiljana and Krajnović, Dušanka",
year = "2013",
abstract = "This paper discusses how a system approach to management can be used for the development and implementation of an integrated management system (IMS) in a company producing medicinal products. It is argued in the paper that approaches to the solutions of how to integrate management systems all require two elements: a conceptual model and a supporting methodology. Although a large number of models has been developed that could provide the basis for integration, development of methodologies to achieve fully integrated systems is still stagnating. This paper presents the IMS model that can be used to integrate the requirements of existing and upcoming standards in the pharmaceutical industry, followed by a discussion on the issue of the IMS methodology.",
publisher = "Assoc Pharmaceutical Teachers India, Bangalore",
journal = "Indian Journal of Pharmaceutical Education and Research",
title = "Approach to the Integration of Management Systems in a Pharmaceutical Organization",
volume = "47",
number = "3",
pages = "19-25",
doi = "10.5530/ijper.47.3.4"
}

Bekcić, S., Kelecević, N., Marinković, V., Tasić, L.,& Krajnović, D.. (2013). Approach to the Integration of Management Systems in a Pharmaceutical Organization. in Indian Journal of Pharmaceutical Education and Research
Assoc Pharmaceutical Teachers India, Bangalore., 47(3), 19-25.
https://doi.org/10.5530/ijper.47.3.4

Bekcić S, Kelecević N, Marinković V, Tasić L, Krajnović D. Approach to the Integration of Management Systems in a Pharmaceutical Organization. in Indian Journal of Pharmaceutical Education and Research. 2013;47(3):19-25.
doi:10.5530/ijper.47.3.4 .

Bekcić, Stana, Kelecević, Nenad, Marinković, Valentina, Tasić, Ljiljana, Krajnović, Dušanka, "Approach to the Integration of Management Systems in a Pharmaceutical Organization" in Indian Journal of Pharmaceutical Education and Research, 47, no. 3 (2013):19-25,
https://doi.org/10.5530/ijper.47.3.4 . .