scholarly journals Comparative analysis of materiovigilance systems of Macedonia, USА, EU, Japan and China and their role in public health

2019 ◽  
Vol 11 (1) ◽  
pp. 20-30
Author(s):  
Vlatko Kokolanski ◽  
Suzana Trajkovikj -Jolevska ◽  
Rozalinda Isjanovska ◽  
Kiro Ivanovski ◽  
Katarina Dirjanska
Keyword(s):  
Public Health ◽  
Medical Device ◽  
Legal Framework ◽  
Shared Responsibility ◽  
Regulation System ◽  
Legal Norms ◽  
Advantages And Disadvantages ◽  
Republic Of Macedonia ◽  
The Republic ◽  
Japan And China

Materiovigilance is a system applied for the purpose of detecting, gathering, monitoring, assessing and responding to new data on safety of medicinal products and related to the use of medical device related to possible incidents during use. The aim of this paper was to show the characteristics of the system of materiovigilance in the Republic of Macedonia compared to four other jurisdictions (US, EU, Japan and China), the recognition of the advantages and disadvantages of the systems and their impact on public health. Material and methods: For the realization of the aim of the study, we conducted an analysis of data published on the web pages of regulatory authorities related to the existing legal framework and review of the literature available on the network for scientists and researchers ResearchGate. General dialectical method as well as legal methods (dogmatic and normative method) were used in this study in order to determine the content, the meaning and the importance of the legal norms which regulate the system of materiovigilance. Results: The five systems of materiovigilance have several features that include monitoring of adverse events caused by medical device that have been granted a marketing authorization. Globally, these systems provide different, shared responsibility of all stakeholders. Thus, the scope of responsibilities of producers is significantly higher in Japan and China, opposed to the EU and Macedonia, where the responsibility is passed on to distributors, health professionals and other for-profit entities. United States is in the middle between these two extreme systems of materiovigilance, where the FDA has the responsibility to protect the public health forecasting responsibilities to the industry. Conclusion: There are significant variations in the regulation system of materiovigilance in the Republic of Macedonia and the analyzed legal systems. To date, there is no empirical evidence that one system is better than another, but it is indisputable that each system has its advantages and disadvantages regarding the protection of public health. Within the analyzed systems of materiovigilance three best practices can be seen that contribute to the improvement of public health: transparency, repeating the examination of medical device and central versus local control. 

Legal and Institutional Framework of Local Self-Government in the Republic of Macedonia

10.4335/76 ◽  
2009 ◽  
Vol 7 (2) ◽  
pp. 107-127
Author(s):  
Gordana Siljanovska Davkova
Keyword(s):  
Political Culture ◽  
Culturally Diverse ◽  
Positive Impact ◽  
Local Development ◽  
Legal Framework ◽  
Republic Of Macedonia ◽  
Municipal Management ◽  
The Republic ◽  
Local Leaders

In general, a comprehensive and well-designed local self-government will significantly improve community management in the Republic of Macedonia. The increased competences and strengthening of the political culture of the population will result in a more active participation of citizens in local processes. An increase in the professional level of the executive and administrative bodies along with improved communication with a civil society will have a positive impact on the quality of municipal management. Decentralized approaches to local development can be a sustainable way to preserve multiculturalism in an ethnically and culturally diverse country. The outcome of the process will depend on the level of public engagement, accountability of local leaders, and transparency of procedures. KEYWORDS: • local self-government • legal framework • municipality • decentralization • Macedonia

scholarly journals Biomedical Journals in Republic of Macedonia: the Current State

PRILOZI ◽  
2014 ◽  
Vol 35 (3) ◽  
pp. 43-50
Author(s):  
Momir Polenakovic ◽  
Lenche Danevska
Keyword(s):  
Public Health ◽  
Biomedical Science ◽  
Bibliographic Databases ◽  
Medical Sciences ◽  
Republic Of Macedonia ◽  
Pubmed Database ◽  
Biomedical Journals ◽  
The Republic ◽  
Basic Characteristics ◽  
Academy Of Sciences

AbstractSeveral biomedical journals in the Republic of Macedonia have succeeded in maintaining regular publication over the years, but only a few have a long-standing tradition. In this paper we present the basic characteristics of 18 biomedical journals that have been published without a break in the Republic of Macedonia. Of these, more details are given for 14 journals, a particular emphasis being on the journal Prilozi/Contributions of the Macedonian Academy of Sciences and Arts, Section of Medical Sciences as one of the journals with a long-term publishing tra-dition and one of the journals included in the Medline/PubMed database. A brief or broad description is given for the following journals: Macedonian Medical Review, Acta Morphologica, Physioacta, MJMS - Macedonian Journal of Medical Sciences, International Medical Journal Medicus, Archives of Public Health, Epilepsy, Macedonian Orthopaedics and Traumatology Journal, BANTAO Journal, Macedonian Dental Review, Macedonian Pharmaceutical Bulletin, Macedonian Veterinary Review, Journal of Special Education and Rehabilitation, Balkan Journal of Medical Genetics, Contributions of the Macedonian Scientific Society of Bitola, Vox Medici, Social Medicine: Professional Journal for Public Health, and Prilozi/Contributions of the Macedonian Academy of Sciences and Arts. Journals from Macedonia should aim to be published regularly, should comply with the Uniform requirements for manuscripts submitted to biomedical journals, and with the recommendations of reliable organizations working in the field of publishing and research. These are the key prerequisites which Macedonian journals have to accomplish in order to b? included in renowned international bibliographic databases. Thus the results of biomedical science from the Republic of Macedonia will be presented to the international scientific arena.

scholarly journals The Fundamental Human Right to Marry and to Family Life and their Protection in the Legal Framework of the Republic of Macedonia

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
M.Sc. Albana Metaj-Stojanova
Keyword(s):  
Family Life ◽  
Nuclear Family ◽  
Legal Framework ◽  
Human Right ◽  
Family Structures ◽  
Degree Of Protection ◽  
Republic Of Macedonia ◽  
The Family ◽  
The Republic ◽  
The Right

The right to family life is a fundamental human right, recognized by a series of international and European acts, which not only define and ensure its protection, but also emphasize the social importance of the family unit and the institution of marriage. The right to family life has evolved rapidly, since it was first introduced as an international human right by the Universal Declaration of Human Rights (UDHR). The family structure and the concept of family life have changed dramatically over the last few decades, influenced by the everchanging social reality of our time and the decline of the institution of marriage. Aside from the traditional European nuclear family composed of two married persons of opposite sex and their marital children, new forms of family structures have arisen. LGTB families are at the centre of the ongoing debate on re-defining marriage and the concept of family life. The aim of this paper is to analyse the degree of protection accorded to family life and to the right to marry, which has long been recognized as one of the vital personal rights essential to the pursuit of happiness by free men by both, international acts ratified by the Republic of Macedonia and the legal system of the country. The methodology applied is qualitative research and use of the analytical, historical and comparative methods. The paper concludes that in general Republic of Macedonia has a solid legal framework, in compliance with the international law, that protects and promotes the right to family life.

scholarly journals Public Health Aspects of Human Brucellosis in the Republic of Macedonia

2013 ◽  
Vol 1 (1) ◽  
pp. 108-111
Author(s):  
Milka Zdravkovska ◽  
Zharko Stojmanovski ◽  
Vaso Taleski ◽  
Svetlana Jovevska ◽  
Velo Markovski
Keyword(s):  
Public Health ◽  
Public Health Problem ◽  
Annual Reports ◽  
Human Brucellosis ◽  
High Morbidity ◽  
Infected People ◽  
Republic Of Macedonia ◽  
The Republic ◽  
Development Tendency ◽  
Epidemiological Characteristics

Background: The Republic of Macedonia is an endemic area where brucellosis is a dominant zoonosis with high morbidity and enormous economic loss.Aim: To determine the incidence rate, prevalence rate and development tendency of infected people with brucellosis in R. Macedonia in the period from 01.01.1999 to 31.12.2009, to register and analyse the epidemiological characteristics of the infected with brucellosis according to gender, age and regional distribution.Materials and methods: The data about the infected people with brucellosis were taken from the register of individual cases as well as monthly and annual reports for infectious diseases prepared by the Institute for Public Health of Republic of Macedonia.Results:  According to the survey the highest number of incidence of human brucellosis in R. Macedonia was found in 2008, 23.94/100,000 people, and the lowest number of infected people was in 2009, about 13.99/100,000 people. Human brucellosis has a decreasing tendency.Conclusion: Human brucellosis remains a public health problem in Republic of Macedonia.

scholarly journals Heraldry in the Republic of Macedonia (1991–2019)

Genealogy ◽  
2021 ◽  
Vol 5 (4) ◽  
pp. 94
Author(s):  
Jovan Jonovski
Keyword(s):  
European Country ◽  
Legal Framework ◽  
Recent Change ◽  
The State ◽  
First Century ◽  
Republic Of Macedonia ◽  
Artistic Representations ◽  
The Republic ◽  
Coats Of Arms ◽  
National Corpus

Every European country now has some distinctive heraldic conventions and traditions embodied in the designs and artistic representations of the emblems forming part of its national corpus. This paper deals with these matters in the period from independence in 1991 to the recent change of name in 2019. It deals with the successive designs proposed for the emblem of the state itself, some of which conformed to international heraldic conventions closely enough to be called “arms” or “coats of arms”, not including the emblem adopted in 2009. Special attention is given to the distinctive conventions created for municipal heraldry, including its novel legal framework, as well as those governing personal heraldry developed in the twenty-first century. The paper examines the evolution of heraldic thought and practice in Macedonia in the three decades in question, especially in the context of the Macedonian Heraldic Society and its journal, The Macedonian Herald, and its Register of Arms and the Civic Heraldic System it created.

Financing Municipal Utility Activities and Local Public Enterprises by Way of Illustrating the Situation in the Republic of Macedonia

10.4335/78 ◽  
2009 ◽  
Vol 7 (2) ◽  
pp. 141-158 ◽  
Author(s):  
Vesna Pendovska ◽  
Aleksandra Maksimovska Veljanovska
Keyword(s):  
Legal Framework ◽  
Public Enterprise ◽  
Public Enterprises ◽  
User Charges ◽  
Utility Company ◽  
Republic Of Macedonia ◽  
Current Economic Situation ◽  
Utility Companies ◽  
Utility Services ◽  
The Republic

This paper is about the local utility services in the decentralization process in the Republic of Macedonia. Particular emphasis is placed on the legal framework for financing municipal utility services through the decentralization process. Since the utility service tariffs are relatively low, the Macedonian utility companies want to increase their tariffs up to cost recovery levels to achieve higher standards required by the EU Directives. The paper also deals with financial relations between the central and local authorities versus the utility company management and the current state of providing utility services in light of financial issues. It has been found out that there is a huge potential to improve user charges. However, due to the current economic situation and the unwillingness of customers to pay higher fees, this solution cannot be applied for the time being. KEY WORDS: • public service delivery • financing municipal activities • public enterprise • Macedonia

scholarly journals The Ilioinguinal Approach versus the Anterior Intrapelvic Approach to the Acetabulum: A Review

2013 ◽  
Vol 1 (1) ◽  
pp. 140-147
Author(s):  
Ilir Hasani ◽  
Igor Kaftandziev ◽  
Simon Trpeski ◽  
Ljupco Nikolov ◽  
Alek Saveski ◽  
...  
Keyword(s):  
Complication Rate ◽  
Day Surgery ◽  
Acetabular Fractures ◽  
Review Of Literature ◽  
Ilioinguinal Approach ◽  
Advantages And Disadvantages ◽  
Republic Of Macedonia ◽  
Significant Difference ◽  
Golden Standard ◽  
The Republic

The ilioinguinal approach (IIA) to the acetabulum has been used as a golden standard for fifty years to treat “anterior” acetabular fractures. Since its introduction by Hirvensalo and Cole, the anterior intrapelvic approach (AIPA) has been adopted by some surgeons, whilst others remain devoted to the IIA. IIA is routinely used in the Republic of Macedonia. The aim of this study is to present a review of literature for two different anterior approaches for the treatment of acetabular fractures used in modern day surgery, focussing on AIPA and its priorities and comparing it to IIA.We performed a search, mainly electronically, and retrospective analysis of existing literature. We have identified and selected two representative and well-systematized papers for IIA, and six for AIPA. We presented the advantages and disadvantages, priorities and weaknesses of both approaches separately, comparing complications, risks and results. Based on the facts presented regarding the advantages of AIPA with a focus on visualization, accessibility and biomechanical justification, the approach should be implemented in our everyday practice and we are comfortable in stating this preference, especially due to the fact that upon comparison of the complication rate there is no significant difference between the two approaches.

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