scholarly journals Orphan Dugs in EU / Lieky na zriedkavé choroby v EÚ

2013 ◽  
Vol 60 (Supplementum-VIII) ◽  
pp. 26-31 ◽  
Author(s):  
T. Foltánová ◽  
M. Mazág
Keyword(s):  
Medicinal Product ◽  
Small And Medium Enterprises ◽  
Orphan Drugs ◽  
Added Value ◽  
Medicinal Products ◽  
Orphan Medicinal Product ◽  
Whole Process ◽  
Orphan Medicinal Products ◽  
Commission Regulation ◽  
Medium Enterprises

Medical and scientific knowledge about rare diseases is minimal or lacking, thus making research difficulties for pharmaceutical industry. Orphan drugs in EU are under supervision of European Commission, European medical agency (EMA) and Committee for orphan medicinal products (COMP). The presentation provides a brief review of all supportive incentives in the field of orphan medicinal products as: the European orphan medicinal product (OMP) regulation, Guideline on Clinical Trials in Small Populations and Commission Regulation (EC) No 2049/2005 / support of small and medium enterprises (SMEs). It also introduces the concept of Clinical added value of orphan medicinal products, as one of the key instruments to increase the availability of orphan medicinal products in the member states. Separately it stresses the necessity of Health technology assessment implementation in whole process of orphan medicinal product development as well as the implementation of the Europlan indicators into the Slovak National plan

scholarly journals New tools and opportunities in growth and climate friendly greening for small and medium enterprises in the European Union

2015 ◽  
Vol 9 (4) ◽  
pp. 25-31
Author(s):  
Xénia Szanyi-Gyenes ◽  
György Mudri ◽  
Mária Bakosné Böröcz
Keyword(s):  
Economic Growth ◽  
Environmental Sustainability ◽  
Small And Medium Enterprises ◽  
Sustainable Growth ◽  
Added Value ◽  
Easy Access ◽  
The European Union ◽  
Access To Finance ◽  
Medium Enterprises ◽  
The Eu

The role of Small and Medium Enterprises (SMEs) is unquestionable in the European economies, while financial opportunities are still inadequate for them. The more than 20 million SMEs play a significant role in European economic growth, innovation and job creation. According to the latest EC Annual Report , SMEs are accounting for 99% of all non-financial enterprises, employing 88.8 million people and generating almost EUR 3.7 tn in added value for our economy. Despite the fact that there is plenty of EU funding available for these SMEs, for certain reasons these funds hardly reach them. But we have to see that the EU supports SMEs by various way, e.g. by grants, regulatory changes, financial instrument, direct funds. On the other hand, SMEs and decision makers realised that the environmental sustainability has to be attached to the economic growth, therefore more and more tools are available for these enterprises. Over the last few years, public institutions, the market, the financial community and non-governmental associations have explicitly demanded that firms improve their environmental performance. One of the greatest opportunities might lay in the Climate- and Energy Strategy till 2030 as 20% of the EU budget is allocated to climate-related actions, however the easy access to finance is still a key question. Does the EU recognise the actual difficulties? Is there a systemic reason behind the absorption problems? Is the EU creating a more businessfriendly environment for SMEs, facilitating access to finance, stimulates the green and sustainable growth and improving access to new markets? The paper analyses the current European situation of the SMEs and the effectiveness of some new tools, which are specially targeting SMEs. JEL classification: Q18

scholarly journals Factors behind trade credit financing of SMEs in Croatia

2020 ◽  
Vol 8 (1) ◽  
pp. 59-76
Author(s):  
Sandra Pepur ◽  
Dujam Kovač ◽  
Marijana Ćurak
Keyword(s):  
Trade Credit ◽  
Small And Medium Enterprises ◽  
Added Value ◽  
Knowledge Generation ◽  
External Financing ◽  
The European Union ◽  
East European ◽  
Funding Sources ◽  
Credit Financing ◽  
Medium Enterprises

Small and medium enterprises (SMEs) contribute to the national economy in terms of employment, added value, knowledge generation, and innovation. However, their potential and in the case of economic downturns even their survival is affected by the difficulties in their access to external financing under acceptable terms and adequate timing and amount. In the case of asymmetric information problems, which make SMEs more sensitive to financial market imperfections, trade credit can be a valuable source of financing. In the European Union, trade credit is among the most relevant external funding sources and it is among the most important alternatives to financial intermediaries’ financing. However, there are substantial differences between the countries with respect to availability and use of trade credit. Therefore, this research examines determining (company-specific and country-specific) factors behind the use of trade credit as a financing source in Croatia. The empirical analysis is based on the data for 1,225 SMEs operating in Croatia in the period from 2008 to 2017 and is done using the panel data methodology. The findings confirm that firms’ characteristics, as well as the characteristics of financial, macroeconomic and legal environment in which the firms operate, influence the use of trade credit in SMEs in Croatia. The paper contributes to relatively scarce empirical evidence on the determinants of trade credit use by SMEs in South-East European countries.

scholarly journals New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation

2010 ◽  
Vol 61 (3) ◽  
pp. 311-322
Author(s):  
Adrijana Martinac ◽  
Siniša Tomić ◽  
Mirna Šimičić
Keyword(s):  
European Commission ◽  
Medicinal Product ◽  
Marketing Authorisation ◽  
Regulatory System ◽  
Efficacy And Safety ◽  
Medicinal Products ◽  
Commission Regulation ◽  
Approval Procedure ◽  
Definition Of ◽  
The Eu

New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian LegislationVariations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

scholarly journals Innovative Activity of Small and Medium- Sized Enterprises

2021 ◽  
Vol 27 (4) ◽  
pp. 580-608
Keyword(s):  
Comparative Analysis ◽  
Small And Medium Enterprises ◽  
Added Value ◽  
Innovation Activity ◽  
Processing Industry ◽  
Innovative Performance ◽  
Secondary Information ◽  
Medium Enterprises ◽  
Published Research ◽  
Stimulation Of

The importance of small and medium enterprises (SMEs) for the economy of our country is constantly growing. In 2018, they made up 99.8% of the enterprises in the country. They employ 75.7% of all employees in the economy and they provide 65.3% of the country‘s added value. The innovation activity of SMEs largely determines the overall innovative performance of our country, and therefore the pace of its development. It is increasingly realized that the stimulation of innovation in SMEs is an important mechanism for achieving competitiveness and economic success not only of individual enterprises but also of our country as a whole. Given this, the first purpose of this study is to perform a comparative analysis of the innovation activity of Bulgarian SMEs compared to the other EU countries and to determine the main areas of achievement and lag. The comparative analysis was performed on the basis of data from official national, European and world sources, as well as from published research results on this issue. The second purpose is to present the results of an empirical study of the innovation activity of a sample of Bulgarian SMEs, conducted by the authors. The survey covers 100 micro, small and medium-sized enterprises from different sectors of the processing industry and its purpose is to check, supplement and clarify secondary information studied for the first stage.

scholarly journals Kenaikan Omzet UMKM Makanan dan Minuman di Kota Bogor Pasca Sertifikasi Halal

Al-Muzara ah ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 109-127
Author(s):  
Hana Khairunnisa ◽  
Deni Lubis ◽  
Qoriatul Hasanah
Keyword(s):  
Small And Medium Enterprises ◽  
Descriptive Analysis ◽  
Linear Regression Analysis ◽  
Multiple Linear Regression Analysis ◽  
Work Hours ◽  
Added Value ◽  
Total Revenue ◽  
Food And Beverage ◽  
Before And After ◽  
Medium Enterprises

Halal certification is one of the company’s strategy that aims to retain their consumers and become a difference with competitors and to give added value for product. Most of the researchers have proved that halal certificates affect big companies’ total revenue. However, there are not many studies that have proved that halal certificate would affect the total revenue of micro, small, and medium enterprises (MSMEs), especially in Bogor City. This research aims to determine the characteristics of MSMEs’ owners and their business, analyze the changes of MSME’s total revenue before and after owning a halal certificate, and the factors that affect MSMEs’ total revenue after owning a halal certificate. The questionnaire data were collected through an interview with 40 food and beverage MSMEs’ owners who have halal certificates in Bogor City. This research uses descriptive analysis, paired sample t-test, and multiple linear regression analysis as the analysis methods. Results based on this research showed that there was a difference in the total revenue of MSMEs before and after owning a halal certificate. The factors that have positive and significant effects of MSMEs’ total revenue influences are capital, work hours, length of business, and a dummy of promotion.

scholarly journals INNOVATION CLUSTERS AS AN ASSOCIATION MODEL OF THE SMALL AND MEDIUM-SIZED ENTERPRISES: THE CONTEXT OF REGIONAL DEVELOPMENT

2020 ◽  
Author(s):  
Ivana Kostadinović ◽  
◽  
Sunčica Stanković ◽  
Keyword(s):  
Regional Development ◽  
Small And Medium Enterprises ◽  
Empirical Studies ◽  
Added Value ◽  
Western Balkans ◽  
Services Sector ◽  
High Level ◽  
Medium Enterprises ◽  
Innovation Clusters

Numerous empirical studies have long been indicated the importance of business infrastructure for economic and regional development. Ensuring long-term economic growth, as well as the creation and development of small and medium enterprises (SMEs), as key drivers of the development of modern economies, requires a high level of efficiency and flexibility of business infrastructure. In the Western Balkans, the absence of a coherent business infrastructure network is the biggest obstacle to the rapid growth of their economies. For this reason, the activities of the Western Balkan governments in the future should be aimed at developing a network of business infrastructure in order to increase the share of the knowledge and services sector with high added value in the economic structure. This paper aims to point out the role of innovative clusters as a model of associating SMEs in the context of regional development.

scholarly journals Pelatihan Desain dan Kemasan Produk Sebagai Upaya Meningkatkan Omset UMKM di Kota Batam

2021 ◽  
Vol 2 (2) ◽  
pp. 121-130
Author(s):  
Debby Arisandi ◽  
Ahmad Fitriansyah
Keyword(s):  
Gross Domestic Product ◽  
Community Service ◽  
Small And Medium Enterprises ◽  
Added Value ◽  
Domestic Product ◽  
Function Type ◽  
Product Packaging ◽  
Service Activities ◽  
Medium Enterprises

The Micro, Small, and Medium Enterprises (MSMEs) sector contributed 60.34% to the gross domestic product (GDP) and assisted the absorption of labor by 97.22%. The problem is, there are still many MSMEs that are not aware or do not understand that good and attractive product packaging will bring added value to the products it offers. As a result, some products that actually have high selling value/quality do not sell in the market. This activity aims to increase the understanding of MSME players of the importance of packaging so that the products offered an increase in added value and can differentiate packaging based on function, type, and material. The implementation of community service activities was carried out on 18-19 July 2017 in the Gurindam Building Hall of the Batam City Education Office. The activity was carried out in collaboration with the Dinas Koperasi dan Usaha Mikro Kota Batam, which was attended by 128 MSMEs. The results of the activity were in the form of new packaging for participant products that were more attractive, informative, and modern. Abstrak Sektor Usaha Mikro, Kecil dan Menengah (UMKM) memberikan kontribusi terhadap produk domestik bruto (PDB) sebesar 60.34% dan membantu penyerapan tenaga kerja sebesar 97.22%. Permasalahannya, masih banyak UMKM tidak sadar atau kurang memahami bahwa kemasan produk yang baik dan menarik akan mendatangkan nilai lebih pada produk yang ditawarkannya. Akibatnya sejumlah produk yang sebenarnya memiliki nilai jual tinggi/bermutu menjadi tidak laku dipasaran. Kegiatan ini bertujuan untuk dapat meningkatkan pemahaman pelaku UMKM terhadap pentingnya kemasan agar produk yang ditawarkan meningkat nilai tambahnya dan dapat membedakan kemasan berdasarkan fungsi, jenis dan bahannya. Pelaksanaan kegiatan pengabdian kepada masyarakat dilaksanakan pada 18-19 Juli 2017 di Aula Gedung Gurindam kantor Dinas Pendidikan Kota Batam.  Kegiatan dilaksanakan melalui kerjasama dengan Dinas Koperasi dan Usaha Mikro Kota Batam yang diikuti oleh 128 UMKM. Hasil kegiatan berupa kemasan baru bagi produk-produk peserta yang lebih menarik, informatif dan modern. Kata Kunci: umkm; pelatihan; kemasan

scholarly journals The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy

2021 ◽  
Vol 12 ◽  
Author(s):  
Entela Xoxi ◽  
Karen M Facey ◽  
Americo Cicchetti
Keyword(s):  
Pharmaceutical Companies ◽  
Medicinal Products ◽  
Value For Money ◽  
Orphan Medicinal Product ◽  
Collection System ◽  
Web Based ◽  
Best Value ◽  
Orphan Medicinal Products ◽  
Managed Entry Agreements ◽  
Equal Split

Italy has a well-established prominent system of national registries to support managed entry agreements (MEAs), monitoring innovative medicinal products (MPs) with clinical as well as economic uncertainties to ensure appropriate use and best value for money. The technological architecture of the registries is funded by pharmaceutical companies, but fully governed by the national medicines agency (AIFA). A desktop analysis was undertaken of data over a 15-year timeframe of all AIFA indication-based registries and associated EMA information. The characteristics of registries were evaluated, comparing orphan MPs vs. all MPs exploring cancer and non-cancer indications. OMP (orphan medicinal product) registries’ type vs. AIFA innovation status and EMA approval was reviewed. Of the 283 registries, 182 are appropriateness registries (35.2% relate to OMPs, with an almost equal split of cancer vs. non-cancer for OMPs and MPs), 35 include financial-based agreements [20% OMPs (2 non-cancer, 5 cancer)], and 60 registries are payment by result agreements [23.3% OMPs (4 non-cancer, 10 cancer)]. Most OMPs (53/88) came through the normal regulatory route. With the strengthening of the system for evaluation of innovation, fewer outcomes-based registries have been instigated. AIFA has overcome many of the challenges experienced with MEA through developing an integrated national web-based data collection system: the challenge that remains for AIFA is to move from using the system for individual patient decisions about treatment to reviewing the wealth of data it now holds to optimize healthcare.

scholarly journals Implementasi Layanan Cloud Computing Software As a Service Pada Usaha Mikro Kecil dan Menengah

2018 ◽  
Vol 17 (3) ◽  
pp. 365
Author(s):  
Rifky Lana Rahardian ◽  
Linawati Linawati ◽  
Made Sudarma
Keyword(s):  
Information Technology ◽  
Cloud Computing ◽  
User Satisfaction ◽  
Small And Medium Enterprises ◽  
Software As A Service ◽  
Added Value ◽  
Computing Services ◽  
Lack Of Information ◽  
Class B ◽  
Medium Enterprises

MSMEs (Micro and Small and Medium Enterprises) have an important role now in the ASEAN economy. 96% of companies in ASEAN are MSMEs. Although MSMEs have shown their role, they still face various obstacles and constraints such as lack of information, weak branding, promotion and infrastructure. The application of information technology will certainly make it easier for MSMEs to strengthen branding, business processing and enable cooperation with other parties to provide added value to MSMEs. The application of cloud computing or cloud computing is considered suitable for MSMEs that have limited resources in the form of capital, human resources (HR) and information technology infrastructure. Responding to the importance of the application of information technology to these MSMEs, the research aims to design and build systems that can facilitate MSMEs by utilizing cloud computing technology with SAAS (software as a service). The system has been tested by testing carried out using the blackbox method which is considered to be running optimally, functionally the system built can produce the output expected by the MSMEe participants. Usability testing to measure the level of satisfaction (user satisfaction) with the usability scale (SUS) system method is also felt necessary so that the system is designed and built according to user needs and satisfaction. With the results of the calculation of SUS 72.25 which means that it belongs to class B or above the average makes SAAS cloud computing services a system that can be accepted by MSMEs participants in supporting their business.  

scholarly journals Economic Crisis and Macro-economic Status of Small and Medium Enterprises

ECONOMICS ◽  
2016 ◽  
Vol 4 (2) ◽  
pp. 9-27
Author(s):  
Zoran Lukić ◽  
Dragan Petrović ◽  
Rankica Marelj
Keyword(s):  
Economic Crisis ◽  
Small And Medium Enterprises ◽  
Economic Status ◽  
Radical Change ◽  
Economic Situation ◽  
Added Value ◽  
Macroeconomic Indicators ◽  
Balkan Region ◽  
Medium Enterprises ◽  
The Eu

Summary Small and medium enterprises comprise an optimal unity with large enterprises. Such approach provides an effective long-term economic structure. In the EU, the number of employees and added value of SMEs grew until 2008, followed by a stagnant trend during the crisis in the EU. As early as 2010, the added value started recovering, while a number of companies and employees stagnated. As for BiH, SMEs revenues dropped in the period from 2008 to 2009, followed by their recovery and growth, while the investments maintained constant decline to the end of the observed period. Macroeconomic indicators do not indicate a radical change of trends from 2008 to 2011. In that period, the EU recorded significant oscillations. Correlation analysis for BiH has shown an interconnection between GDP and industrial production, with SMEs revenues. The ratio of investments and SMEs revenues does not indicate the existence of a correlation. The economic crisis and instability of BiH affect the poor economic situation. BiH underutilizes EU funds for SME development. The EU Programme for SMEs and job creation has failed to demonstrate significant results in Bosnia and Herzegovina and the Balkan region. The economic crisis and instability affect the economic situation in BiH. Stimulus of creating new and expansion of existing SMEs is a prerequisite for economic recovery of the country in times of crisis and in the periods of economic prosperity.

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