TY  - JOUR
AU  - Pejović, Gordana
AU  - Filipović, Jovan
AU  - Tasić, Ljiljana
AU  - Marinković, Valentina
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2601
AB  - The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteriathe regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions. Copyright
PB  - Wiley-Blackwell, Hoboken
T2  - International Journal of Health Planning and Management
T1  - Towards medicines regulatory authorities' quality performance improvement: value for public health
VL  - 31
IS  - 1
DO  - 10.1002/hpm.2265
ER  - 

@article{
author = "Pejović, Gordana and Filipović, Jovan and Tasić, Ljiljana and Marinković, Valentina",
year = "2016",
abstract = "The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteriathe regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions. Copyright",
publisher = "Wiley-Blackwell, Hoboken",
journal = "International Journal of Health Planning and Management",
title = "Towards medicines regulatory authorities' quality performance improvement: value for public health",
volume = "31",
number = "1",
doi = "10.1002/hpm.2265"
}

Pejović, G., Filipović, J., Tasić, L.,& Marinković, V.. (2016). Towards medicines regulatory authorities' quality performance improvement: value for public health. in International Journal of Health Planning and Management
Wiley-Blackwell, Hoboken., 31(1).
https://doi.org/10.1002/hpm.2265

Pejović G, Filipović J, Tasić L, Marinković V. Towards medicines regulatory authorities' quality performance improvement: value for public health. in International Journal of Health Planning and Management. 2016;31(1).
doi:10.1002/hpm.2265 .

Pejović, Gordana, Filipović, Jovan, Tasić, Ljiljana, Marinković, Valentina, "Towards medicines regulatory authorities' quality performance improvement: value for public health" in International Journal of Health Planning and Management, 31, no. 1 (2016),
https://doi.org/10.1002/hpm.2265 . .

TY  - JOUR
AU  - Pejović, Gordana
AU  - Filipović, Jovan
AU  - Tasić, Ljiljana
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1520
AB  - The primary role of European pharmaceutical legislation is to safeguard public health while encouraging the development of the pharmaceutical industry, creation of single market for pharmaceuticals with removed barriers to medicines trade. This article presents some important characteristics of pharmaceutical legislation in Serbia, the potential EU candidate country, and the latest improvements of existing national pharmaceutical legislation. Additional explanation is given for the Serbian negotiations with World Trade Organization and measures taken for the harmonisation with Agreements on Technical barriers to Trade (TBT), especially with Agreement on Trade-Related Intellectual Property Rights. Current status of Serbian pharmaceutical market is described, with the highlight of domestic manufacturers' capacity to comply with European Union requirements. National medicines agency is described in the framework of European medicines quality infrastructure. The role and responsibility of national medicines authority to assure access to quality, safe and efficacious medicines on Serbian market is described. The special emphasis is given to agency's role in harmonisation process, in terms of removing unnecessary barriers to medicines trade in Serbia.
PB  - Springer, New York
T2  - Accreditation and Quality Assurance
T1  - How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia
VL  - 16
IS  - 4-5
SP  - 253
EP  - 261
DO  - 10.1007/s00769-010-0749-7
ER  - 

@article{
author = "Pejović, Gordana and Filipović, Jovan and Tasić, Ljiljana",
year = "2011",
abstract = "The primary role of European pharmaceutical legislation is to safeguard public health while encouraging the development of the pharmaceutical industry, creation of single market for pharmaceuticals with removed barriers to medicines trade. This article presents some important characteristics of pharmaceutical legislation in Serbia, the potential EU candidate country, and the latest improvements of existing national pharmaceutical legislation. Additional explanation is given for the Serbian negotiations with World Trade Organization and measures taken for the harmonisation with Agreements on Technical barriers to Trade (TBT), especially with Agreement on Trade-Related Intellectual Property Rights. Current status of Serbian pharmaceutical market is described, with the highlight of domestic manufacturers' capacity to comply with European Union requirements. National medicines agency is described in the framework of European medicines quality infrastructure. The role and responsibility of national medicines authority to assure access to quality, safe and efficacious medicines on Serbian market is described. The special emphasis is given to agency's role in harmonisation process, in terms of removing unnecessary barriers to medicines trade in Serbia.",
publisher = "Springer, New York",
journal = "Accreditation and Quality Assurance",
title = "How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia",
volume = "16",
number = "4-5",
pages = "253-261",
doi = "10.1007/s00769-010-0749-7"
}

Pejović, G., Filipović, J.,& Tasić, L.. (2011). How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia. in Accreditation and Quality Assurance
Springer, New York., 16(4-5), 253-261.
https://doi.org/10.1007/s00769-010-0749-7

Pejović G, Filipović J, Tasić L. How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia. in Accreditation and Quality Assurance. 2011;16(4-5):253-261.
doi:10.1007/s00769-010-0749-7 .

Pejović, Gordana, Filipović, Jovan, Tasić, Ljiljana, "How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia" in Accreditation and Quality Assurance, 16, no. 4-5 (2011):253-261,
https://doi.org/10.1007/s00769-010-0749-7 . .

TY  - JOUR
AU  - Pejović, Gordana
AU  - Otašević, Biljana
AU  - Zečević, Mira
AU  - Kuntić, Vesna
AU  - Vujić, Zorica
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1432
AB  - The present work describes forced degradation study of valdecoxib, under different ICH recommended stress conditions - photolytic degradation, oxidation, hydrolysis in alkaline and acidic conditions as well as its thermal degradation. Stress studies were performed at valdecoxib drug substance and the final dosage form. Chromatographic separations of drug and the degradation products formed under various experimental conditions was successfully achieved on RP-18e Chromolith® performance monolithic column (100 mm × 4.6 mm, macropore size 2 μm, mesopore size 13 nm) with an eluent containing the mixture of methanol and water solution of TEA (1%, pH 7.4) in the ratio 40:60 (v/v) while the column temperature was adjusted to 30°C. Detection was performed using photodiode array detector on several wavelengths in order to ensure the proper insight into drug degradation pathway in case the formed products differ in absorption characteristics.
T2  - Farmaceutyczny Przeglad Naukowy
T1  - Valdecoxib stability properties under forced degradation conditions
VL  - 7
IS  - 9
SP  - 11
EP  - 17
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1432
ER  - 

@article{
author = "Pejović, Gordana and Otašević, Biljana and Zečević, Mira and Kuntić, Vesna and Vujić, Zorica",
year = "2010",
abstract = "The present work describes forced degradation study of valdecoxib, under different ICH recommended stress conditions - photolytic degradation, oxidation, hydrolysis in alkaline and acidic conditions as well as its thermal degradation. Stress studies were performed at valdecoxib drug substance and the final dosage form. Chromatographic separations of drug and the degradation products formed under various experimental conditions was successfully achieved on RP-18e Chromolith® performance monolithic column (100 mm × 4.6 mm, macropore size 2 μm, mesopore size 13 nm) with an eluent containing the mixture of methanol and water solution of TEA (1%, pH 7.4) in the ratio 40:60 (v/v) while the column temperature was adjusted to 30°C. Detection was performed using photodiode array detector on several wavelengths in order to ensure the proper insight into drug degradation pathway in case the formed products differ in absorption characteristics.",
journal = "Farmaceutyczny Przeglad Naukowy",
title = "Valdecoxib stability properties under forced degradation conditions",
volume = "7",
number = "9",
pages = "11-17",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1432"
}

Pejović, G., Otašević, B., Zečević, M., Kuntić, V.,& Vujić, Z.. (2010). Valdecoxib stability properties under forced degradation conditions. in Farmaceutyczny Przeglad Naukowy, 7(9), 11-17.
https://hdl.handle.net/21.15107/rcub_farfar_1432

Pejović G, Otašević B, Zečević M, Kuntić V, Vujić Z. Valdecoxib stability properties under forced degradation conditions. in Farmaceutyczny Przeglad Naukowy. 2010;7(9):11-17.
https://hdl.handle.net/21.15107/rcub_farfar_1432 .

Pejović, Gordana, Otašević, Biljana, Zečević, Mira, Kuntić, Vesna, Vujić, Zorica, "Valdecoxib stability properties under forced degradation conditions" in Farmaceutyczny Przeglad Naukowy, 7, no. 9 (2010):11-17,
https://hdl.handle.net/21.15107/rcub_farfar_1432 .