scholarly journals Risk assessment of GM trees in the EU: current regulatory framework and guidance

2013 ◽  
Vol 6 (3) ◽  
pp. 127-131 ◽  
Author(s):  
J Aguilera ◽  
K Nielsen ◽  
J Sweet
Keyword(s):  
Risk Assessment ◽  
Regulatory Framework ◽  
Gm Trees ◽  
The Eu

scholarly journals National Food Safety Systems in the European Union: A Comparative Survey

2013 ◽  
Vol 2 (1) ◽  
Author(s):  
Andreas Hadjigeorgiou ◽  
Elpidoforos S. Soteriades ◽  
Anastasios Philalithis ◽  
Anna Psaroulaki ◽  
Yiannis Tselentis ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Food Safety ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Comparative Survey ◽  
Safety Systems ◽  
Central Level ◽  
The Eu

This paper is a comparative survey of the National Food Safety Systems (NFSS) of the European Union (EU) Member-States (MS) and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS) have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA), risk management (RM), and risk communication (RC). We found that in 12 Member States, all three areas of activity (RA, RM, and RC) are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

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 APPLICATION OF THE PERSONAL IDENTIFICATIONAL NUMBER FOR EU CITIZENS RESIDING IN THE REPUBLIC OF BULGARIA - PRACTICAL ASPECTS

2020 ◽  
Author(s):  
Michal Stojanov ◽  
Keyword(s):  
Legal Framework ◽  
Regulatory Framework ◽  
Administrative Services ◽  
The Republic ◽  
The Eu

Bulgaria's membership in the EU is accompanied by the formation of innumerable bene-fits and commitments that the country receives as inevitable effects of its integration. Participa-tion in the EU is a prerequisite for improvement and supranational unification in the regulation of certain elements in the national legal framework and in the organization of administrative services in the country. However, for more than a decade there have been areas in which the established regulatory framework is not adequately reflected in the work of the Bulgarian ad-ministrative structures. The paper examines the application of the identifier Personal Number for EU citizens permanently residing in the Republic of Bulgaria, where it is found that it is insuffi-ciently applied, which results in bad practices and practical difficulties.

scholarly journals An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1447 ◽  
Author(s):  
Robert Carroll ◽  
Sreeram V. Ramagopalan ◽  
Javier Cid-Ruzafa ◽  
Dimitra Lambrelli ◽  
Laura McDonald
Keyword(s):  
Risk Assessment ◽  
Chart Review ◽  
Drug Utilisation ◽  
Data Capture ◽  
Primary Data ◽  
European Medicines Agency ◽  
Therapeutic Area ◽  
The European Union ◽  
Study Designs ◽  
The Eu

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that study objectives and therapeutic area influence PAS design in terms of type of data capture used.

Fundamental review of the trading book: state of art on implementation of Standardised Approach

2021 ◽  
Vol 16 (2) ◽  
pp. 10-20
Author(s):  
Nicoletta Figurelli ◽  
◽  
Carlo Frazzei ◽  
Alessandro Garufi ◽  
Tommaso Giordani ◽  
...  
Keyword(s):  
Risk Management ◽  
Best Practices ◽  
Financial Institutions ◽  
Regulatory Framework ◽  
Regulatory Requirements ◽  
Basel Committee ◽  
Key Points ◽  
Front Office ◽  
State Of Art ◽  
The Eu

Following the publication of the regulatory framework for the Fundamental Review of the Trading Book (FRTB) by both the Basel Committee (BCBS) and the EU Regulator, the Financial Institutions have started the mandatory actions to comply with the new regulatory requirements. This article aims to provide an overview of the key challenges that banks have had to face in recent years, with a particular focus on the most significant methodological key points and the main impacts on business from the technicalities of the new regulatory framework, in order to provide guidelines and best practices on Standardized Approach (SA) topics shared between Risk Management and Front Office

Non-compliance behavior of de-risking force the EU to enhance anti-money laundering regulation

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Kalle Johannes Rose
Keyword(s):  
Money Laundering ◽  
Financial Institutions ◽  
Law And Economics ◽  
Negative Impact ◽  
Regulatory Framework ◽  
Content Type ◽  
Functional Methods ◽  
Compliance Behavior ◽  
The Relationship ◽  
The Eu

Purpose Recent research shows that because of money-laundering risks, there has been an increase in the off-boarding of certain types of corporate clients in the financial sector. This phenomenon known as “de-risking” has been argued to have a negative impact on society, because it increases the possible risk of money laundering. The purpose of this paper is to analyze whether the de-risking strategy of financial institutions results in an expansion of the regulatory framework concerning anti-money laundering focusing on off-boarding of clients and, if so, is there a way to avoid further regulation by changing present behavior. Design/methodology/approach This paper applies functional methods to law and economics to achieve higher efficiency in combating money laundering. Findings In this paper, it is found that the continuing of de-risking by financial institutions because of the avoidance strategy of money-laundering risks will inevitably result in further regulatory demands regarding the off-boarding process of clients. The legal basis for the introduction of further regulatory intervention is that some of the de-risking constitutes a direct contradiction to the aim of the present regulatory framework, making the behavior non-compliant to the regulation. Originality/value There has been very little research concerning de-risking related to money laundering. The present research has focused on the effect on society and not the relationship between the financial institutions and the regulator. This paper raises an important and present problem, as the behavior of the financial institutions constitute a response from the regulator that is contradicting the thoughts behind the behavior of the financial institutions. It is found that the paper is highly relevant if an expansion of regulation is to be hindered.

Introduction

2018 ◽  
pp. 1-22
Author(s):  
Ines Wagner
Keyword(s):  
Labor Market ◽  
Labor Markets ◽  
Regulatory Framework ◽  
Nation State ◽  
Employment Relations ◽  
Labor Market Regulations ◽  
The Eu

The introduction concisely explicates the main points of discussion relevant for the chapters of this book. It shortly analyzes the implications of the de-territorialization of “bounded” national labor markets, sets the scene for how the regulatory framework and is used and its implications for labor market regulations, points to the possibilities for resistance within transnational workspaces, and presents the shifting relationship between the changes in the territorial nation state and its institutional apparatus and among the changes in employment relations in the EU. It shortly outlines the methods and approach.

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