scholarly journals Ochrona interesów jednostki notyfikowanej w systemie oceny zgodności z zasadniczymi wymaganiami w prawodawstwie polskim i unijnym – wybrane zagadnienia administracyjnoprawne

2019 ◽  
Vol 17 (1) ◽  
pp. 195-203
Author(s):  
Agieszka Żywicka
Keyword(s):  
Quality Assurance ◽  
Crucial Role ◽  
Health And Safety ◽  
Assessment System ◽  
Conformity Assessment ◽  
Community Law ◽  
Quality Assurance Mechanism ◽  
Safety Protection ◽  
Notified Body ◽  
The Eu

The category of a notified body is inherently connected with the system of product conformity assessment. Evaluation of a product compliance with essential requirements constituting the European quality assurance mechanism for non-food products placed on the EU single market for goods is aimed at consumers’ health and safety protection. Moreover, it is to ensure a free movement of products. Notified bodies conduct conformity certification against the relevant requirements of the applicable technical harmonisation directive, hence their crucial role in the conformity assessment system. Notified body accreditation requires organisations to obtain a relevant administrative decision, under consideration of the requirements of Community law. The article presents the authorisation process for the provision of conformity assessment services, as well as the legal instruments which safeguard the rights of bodies applying for the appointment.

scholarly journals Current Status and Prospects for the Quality Assurance in Border Guards Training: European Experience

2018 ◽  
Vol 8 (4) ◽  
pp. 20-25 ◽  
Author(s):  
Andrii Balendr
Keyword(s):  
Quality Assurance ◽  
The State ◽  
Current Status ◽  
Quality Assurance System ◽  
Eu Countries ◽  
Assurance System ◽  
Quality Assurance Mechanism ◽  
And Training ◽  
The Eu

Abstract The article reveals the current status of the quality assurance development in the training process of the European Union (EU) border guard agencies. Besides, the study aims to describe the prospects for further quality assurance development of the border guards training in the EU countries. The views of scientists on the concepts of “quality assurance and control” and “quality of training” were critically studied. The quality of a border guard’s training was defined as a set of knowledge, skills and competencies of a border guard, including a border guard’s personal qualities, characteristics, which define a person as a specialist in the sphere of the state border protection and distinguishes him or her from other specialists and ensures success along the border guard career path. The study of the quality assurance system of border guards’ training in the EU countries revealed that it is conducted by the European policies and educational and training standards and promotes the formal certification and external accreditation of border guards’ training. It is indicated that the prospects for developing quality assurance mechanism for all-European border guard courses are connected with the possibility to provide external accreditation for such courses as: Introduction to Educational Technology and Training Delivery Methodology, which the author completed in 2017 and 2018. The process of accreditation is being conducted by an international quality assurance agency. The quality assurance system of the border guards training in EU is used in the Joint European Master’s Program in Strategic Border Management, developed by FRONTEX Agency in cooperation with European educational establishments. So, the State Border Guard Service of Ukraine can be particularly interested in this program, in order to facilitate the increasing of quality of Ukrainian border guards training.

Note on the regulation of veterinary medical devices in the EU: A review of the current situation and its impact on animal health and safety

2020 ◽  
Vol 29 (1) ◽  
pp. 37-43
Author(s):  
H Potockova ◽  
P Kusnierik ◽  
J Dohnal
Keyword(s):  
Veterinary Medicine ◽  
Medical Devices ◽  
Animal Health ◽  
Health And Safety ◽  
Well Being ◽  
Current Situation ◽  
Safety And Efficacy ◽  
Safety Risks ◽  
Health And Safety Risks ◽  
The Eu

Medical devices form a large heterogeneous group of products ranging from simple tools to medical testing and implants, the safety and efficacy of which are strictly regulated in all developed countries. Thanks to the health and cost benefits, medical devices have also found their way into veterinary medicine but, surprisingly, the regulation of these products is far less complex or, in some cases, missing altogether. Given the complexity and potential hazards of certain veterinary devices, the current state of affairs may lead to health and safety risks, both for animals and personnel involved. This review is the first to systematically map the current situation in the EU, revealing health and safety risks in practice for both animals and personnel involved and discussing them in a broader context. Only six out of the EU's 28 member states (Belgium, Croatia, Czech Republic, Germany, Hungary, and Slovakia) were found to have at least a degree of regulation of veterinary devices. As a result, a single product may be regulated as a veterinary medicinal product, a veterinary medical device or not be regulated at all, depending on the particular EU member state in question. As things stand, veterinary medicine makes use of all kinds of medical devices, including human products, regardless of their regulatory status and (pre-market) control. However, the use of such devices may influence the health and well-being of animals. Several measures are therefore suggested to attain the required levels of safety and efficacy surveillance for veterinary medical devices without creating excessive administration.

Signed, Sealed, but not Delivered: The EU and the Ratification of the Marrakesh Treaty

2015 ◽  
Vol 6 (4) ◽  
pp. 629-632
Author(s):  
Ana Ramalho
Keyword(s):  
Intellectual Property ◽  
Technical Progress ◽  
Health And Safety ◽  
Risk Regulation ◽  
Inside View ◽  
Laws And Policies ◽  
Ip Law ◽  
Crossing Point ◽  
Marrakesh Treaty ◽  
The Eu

This section is devoted to giving readers an inside view of the crossing point between intellectual property (IP) law and risk regulation. In addition to updating readers on the latest developments in IP law and policies in technological fields (including chemicals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientific and technical progress and are capable of minimising the risks posed by on-going industrial developments to individuals’ health and safety, inter alia.

scholarly journals State industrial policy in conditions European integration of Ukraine

2020 ◽  
Vol 45 (2) ◽  
pp. 146-153
Author(s):  
Valeriі Rіeznikov
Keyword(s):  
European Union ◽  
European Integration ◽  
Industrial Policy ◽  
Conformity Assessment ◽  
Industrial Complex ◽  
The European Union ◽  
Industrial Products ◽  
Market Surveillance ◽  
Mutual Recognition Agreement ◽  
The Eu

Since the beginning of 2020, there have been crisis phenomena around the world due to the global slowdown in economic growth and the introduction of quarantine due to the coronavirus pandemic. In this situation, the most vulnerable are developing countries with a small margin of safety, which, unfortunately, also applies to Ukraine, whose economy is open and highly dependent on external markets. Due to the slowdown in the growth of the global economy, the situation in one of the main export industries of Ukraine – industry is deteriorating first of all. The European Union has become one of the important export markets for Ukraine’s industrial products in recent years, which has raised the issue of shaping a relevant state industrial policy in today’s challenging environment. The purpose of the article is to determine the directions of formation and implementation of state industrial policy in the conditions of European integration of Ukraine in modern conditions. In 2020, due to the economic crisis and the pandemic of the coronavirus, the Ukrainian industry may lose even more due to low demand for ferrous metals in world markets, including in EU countries. The Agreement on Conformity Assessment and Acceptance of Industrial Products is a way of eliminating technical barriers to trade between Ukraine and the EU. The Agreement on Conformity Assessment and Acceptance of Industrial Products is a type of mutual recognition agreement that requires a partner country to align its legislation, practices and infrastructure with EU rules.It is envisaged that in the sectors covered by this Agreement, Ukrainian exporters will be able to label their products with the CE mark and to sell them freely on the EU market without additional EU certification. Potentially, the Agreement on Conformity Assessment and Acceptance of Industrial Products could cover up to a fifth of Ukraine’s exports to the EU, notably mechanical engineering products. The formation and implementation of state industrial policy in the conditions of European integration of Ukraine should take place using the following algorithm:1. Study of the new EU Regulation 2019/1020 of 20.06.2019 on market surveillance and conformity of products and elaboration of relevant amendments to the legislation of Ukraine.2. Concentration of the function of legal coordination of draft regulatory acts (including technical regulations) aimed at implementing the Association Agreement and preparation for the Agreement on Conformity Assessment and Acceptance of Industrial Products in one state instance, equipped with specialized personnel with adequate knowledge of EU law and languages.3. Strengthening the requirements for the accreditation and oversight process for accredited bodies, as well as the process of designating and monitoring conformity assessment bodies to ensure that their technical competence is adequate and to prevent fraud and the use of fraudulent practices.4. In the absence of a rapid prospect of concluding an Agreement on Conformity Assessment and Acceptance of Industrial Products, the harmonization of procedures and requirements that are too burdensome for exporters and importers, first and foremost.5. Paying particular attention to capacity building of state market surveillance authorities.6. Raising awareness of business entities and enhancing the role of business associations in raising such awareness.7. Increasing the EU’s interest in providing Ukraine with effective technical assistance for the development of legislation and the proper functioning of quality infrastructure and market surveillance authorities. Introduce the position of Deputy Prime Minister for Industry and launch support programs for the real economy. Thus, Ukraine’s further integration with the European Union is largely linked to the formulation and implementation of relevant industrial policy, which should be to continue reforming all sectors of the economy, in particular, to modernize the industrial complex. And the signing of the Agreement on Conformity Assessment and Acceptance of Industrial Products in the three priority sectors («industrial visa waiver») in the medium term should become one of the main foreign economic priorities of Ukraine’s European integration in the face of the current challenges of today.

scholarly journals АНАЛІЗ МІЖНАРОДНИХ ПРИНЦИПІВ І ПІДХОДІВ ДО ОЦІНКИ ВІДПОВІДНОСТІ ГОТЕЛЬНИХ ЗАКЛАДІВ КРИТЕРІЯМ ЯКОСТІ ТА БЕЗПЕКИ

2017 ◽  
Vol 117 (6) ◽  
pp. 80-90
Author(s):  
Ganna I. Khimicheva ◽  
Anastasiia O. Mykhalko ◽  
Daria V. Yaremenko
Keyword(s):  
Assessment System ◽  
Conformity Assessment ◽  
Quality And Safety ◽  
The World ◽  
Security Standard ◽  
Hotel Security

The paper offers a review of the international principles and approaches to the conformity assessment of hotels quality and safety criteria. Given the lack of common approaches in the world practice to the accommodation establishments categorization, in particular, lack of stanard assessment system, it is suggested to build a unified hotels conformity assessment system (categorization) based on the 21 HOTREC principles, Hotelstars Union criteria and the requirements of The Global Hotel Security Standard. This approach will allow consumers obtain valid and transparent information about hotels all over the world. The recommendations provided  will contribute to enhancing the quality and safety of hotel services as well as to boosting the flow of foreign tourists.

scholarly journals Quality Assurance of Online and Distance Learning Education for SAARC Region during Covid-19 Situation

2021 ◽  
Vol 4 (2) ◽  
pp. 507-519
Author(s):  
Muhammad Zia-ur- Rehman ◽  
Asif Mahmood ◽  
Maria Zia
Keyword(s):  
Quality Assurance ◽  
Distance Learning ◽  
Comparative Analysis ◽  
Survey Techniques ◽  
Learning Challenges ◽  
Quality Assurance Mechanism ◽  
E Learning ◽  
Ict Infrastructure ◽  
Second Wave

The outbreak of second wave of COVID-19 pandemic has again halted routine life of normal citizen across the globe. The nature always support the change for better future and covid-19 has provide chance to change challenges into opportunities. This study is sought to examine post Covid-19 effects on ICT infrastructure for e-learning education and its quality assurance mechanism in SAARC countries. This research is descriptive in nature and use comparative analysis of numerous challenges faced by SAARC member countries for implementation of E-learning. Challenges and limitation are also brush-up for further refinement in future in these areas. Future researchers may conduct survey techniques in explanatory research on implementation of ICT infrastructure of SAARC region countries. SAARC member countries may take lead from this study to address challenges and their solutions for development and implementation of E-learning.

scholarly journals Workers with Cardiac AIMD Exposed to EMF: Methods and Case Studies for Risk Analysis in the Framework of the European Regulations

2021 ◽  
Vol 18 (18) ◽  
pp. 9709
Author(s):  
Eugenio Mattei ◽  
Federica Censi ◽  
Giovanni Calcagnini ◽  
Rosaria Falsaperla
Keyword(s):  
Risk Assessment ◽  
Case Studies ◽  
Medical Devices ◽  
Risk Group ◽  
Health And Safety ◽  
Implantable Defibrillator ◽  
Safety Regulation ◽  
Implantable Medical Devices ◽  
European Regulations ◽  
The Eu

Workers with cardiac active implantable medical devices (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), are considered by the occupational health and safety regulation framework as a particularly sensitive risk group that must be protected against the dangers caused by the interference of electromagnetic field (EMF). In this paper, we first describe the general methodology that shall be followed for the risk assessment of employees with a cardiac AIMD exposed to EMF, according to the EU regulation, and in particular to the EN 50527-2-1:2016 and 50527-2-2:2018 standards. Then, three case studies related to specific EMF sources are presented, to better describe how the initial analysis of the risk assessment can be performed in practice, and to understand if a further specific risk assessment analysis is required or not.

scholarly journals The 21st century - the role of the pharmacist in the healthcare

2017 ◽  
Vol 70 (11-12) ◽  
pp. 365-370 ◽  
Author(s):  
Budimka Novakovic ◽  
Maja Milanovic ◽  
Milica Atanackovic-Krstonosic ◽  
Branislava Srdjenovic-Conic ◽  
Neda Gavaric ◽  
...  
Keyword(s):  
Global Health ◽  
21St Century ◽  
Crucial Role ◽  
Life Quality ◽  
Health And Safety ◽  
Efficacy And Safety ◽  
Major Goal ◽  
Pharmacy Profession

The roles of the pharmacist were transformed throughout the history and modern pharmacist as we know now beside providing products and playing in optimization of medicines has a crucial role in ensuring the efficacy and safety of applied drugs. A better life quality, global health and safety is the major goal of the 21st century and to achieve that great span of roles pharmacy profession involves now. The paper highlighted new roles of the pharmacist today in order to better understand the transition of the pharmacy profession.

scholarly journals Legal Education in Pakistan: An Overview

2018 ◽  
Vol 26 (2) ◽  
pp. 401
Author(s):  
Sardar Ali Shah ◽  
Usharani Balasingam ◽  
Saroja Dhanapal
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
Legal Education ◽  
Regulatory System ◽  
Education Institution ◽  
Roles And Responsibilities ◽  
The Past ◽  
Education Commission ◽  
Quality Assurance Mechanism ◽  
Two Bodies

Legal education in Pakistan was initiated before independence and dates back to the 1800s. The first legal education institution was established under the name of ‘University Law College’ in 1868. Currently, there are more than 150 institutions offering law programs, which include universities and law colleges. These institutions are regulated by the Pakistan Bar Council (PBC) and Higher Education Commission (HEC). Over the past decades, there have been a lot of concerns raised on the quality assurance mechanism with regards to legal education in Pakistan. In line with this, the objectives of the current study is to identify and analyse the roles and responsibilities of the HEC and the PBC as regulators of legal education in the country as well as to identify the strengths and weaknesses within this regulatory system as a result of an overlapping of powers between the two bodies. The article ends with recommendations for improvement.

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