Standardized characterization procedures: a necessary support to regulations

2016 ◽  
Vol 74 (1) ◽  
pp. 220-228 ◽  
Author(s):  
Ludovico Spinosa

Sustainable procedures for sludge/biosolids management require the development of strategies to reduce the amount of sludge to be handled and to produce higher quality biosolids. Therefore, realistic and enforceable regulations adapted to local situations must be developed, defined outlet procedures established and good quality products guaranteed. To this end, the definition of standardized characterization procedures and guidelines for good practices becomes a necessary support to regulations. To contribute to the development of the EU directives dealing with sludge, the European Committee for Standardization (CEN) has established Technical Committee 308 (TC 308) whose scope is the standardization of methods for sludge characterization and the production of guidelines of good practice. In this paper, the most recent developments of the CEN/TC 308 work for the chemical, biological and physical characterization of sludge/biosolids are discussed in relation to the main different treatment and outlet options.

This chapter looks at the purpose and history of the development of good clinical practice (GCP). The international conference on harmonisation (ICH) GCP is the international quality standard for conducting clinical research to ensure the rights and well-being of patients are protected and the resulting data are valid. The cornerstone of ethics in research stems from the Declaration of Helsinki and the chapter looks at the changes in the Declaration and the impact on clinical trials. The development of the ICH process is described and the E, S, Q and M guidelines are discussed, The efficacy guidelines affect the practical aspects of trials and the efficacy guideline number 6 (E6) is on GCP. The content of the E6 guidelines is reviewed including the responsibilities of ethics committees, investigator and sponsor. Documentation requirements including the Protocol and Investigator Brochure as well as all the other documents are outlined. The guidelines are written to be interpreted and companies and institutions have to document their interpretation using standard operating procedures (SOPs). Although ICH GCP is regarded as the world-wide standard it sits alongside countries' legislation. In Europe CTIMPs have to follow the EU Directives and Regulation. Non pharmaceutical/non interventional healthcare research has no legal requirements to adhere to ICH GCP and is carried out under different research governance frameworks (RGF), however they all have their principles based on ICH GCP. The chapter also discusses the definition of an IMP and the decisions and processes that have to be followed when conducting non CTIMP studies.


Author(s):  
María Goretti Alonso de Castro ◽  
Francisco José García-Peñalvo

Collecting data from Erasmus+ projects to detect those that have been identified as good practice or success story could be very useful in order to help teachers to define successful projects in a particular field. To compile projects of interest, the Erasmus+ Project Results Platform is available, which has a database with very useful information to locate educational projects that have been funded by the European Union. The advantage of using this tool is that it has a search engine that allows anyone to look up for keywords. Moreover, it permits to define different criteria so as to identify good practices projects that could serve as a reference in order to find useful parameters to improve the teaching process. This chapter presents the main data collected from educational projects that are related to eLearning and related methodologies in the aforementioned platform. It also defines which ones will be selected so as to be able to undertake an adequate analysis that allows the definition of a methodological guide to be carried out.


2019 ◽  
Vol 21 (1) ◽  
pp. 117-139
Author(s):  
Amanda Spalding

Abstract This article considers the impact of the recent judgment of the Court of Justice of the European Union in Case C-673/16 Coman and Others in which same-sex marriages where found to fall under the definition of ‘spouse’ in the Citizenship Directive. In light of recent societal and case law developments in Europe it is possible that Coman may come to be an important foundational case which will form part of the groundwork for the CJEU to advance the rights of unmarried couples in the EU migration context. This article examines the current position of unmarried couples (including registered or civil partners) under EU migration legislation as well as recent developments under the European Convention of Human Rights to argue that there are clear indications that EU migration laws need to be adapted to better suit a wider range of relationships than marriage.


MRS Bulletin ◽  
2010 ◽  
Vol 35 (12) ◽  
pp. 1009-1016 ◽  
Author(s):  
N. D. Browning ◽  
G. H. Campbell ◽  
J. A. Hawreliak ◽  
M. A. Kirk

The fundamental processes taking place in metals under extreme conditions can occur on ultrafast timescales (i.e., nanoseconds to picoseconds), and yet their result can continue to have a significant impact on the structural properties for many years to follow. The challenge in developing in situ methods for characterization under extreme conditions therefore involves both the modification of the instrumentation to implement the high-temperature, strain, and radiation conditions and the definition of the timescale over which the measurement must be made. While techniques are well established for characterization of the long-term effects of extreme conditions, experiments are only just beginning to probe the initial stages of structural evolution. This article reviews recent developments in optical, x-ray, and electron probes of metals under extreme conditions and also discusses the needs for future experiments and potential pathways to achieving these goals.


1988 ◽  
Vol 41 (7) ◽  
pp. 285-296 ◽  
Author(s):  
Ahmed K. Noor

The status and some recent developments of continuum modeling for repetitive lattice structures are summarized. Discussion focuses on a number of aspects including definition of an effective substitute continuum; characterization of the continuum model; and the different approaches for generating the properties of the continuum, namely, the constitutive matrix, the matrix of mass densities, and the matrix of thermal coefficients. Also, a simple approach is presented for generating the analytic expressions and/or numerical values of the continuum properties. Sample numerical results are presented to demonstrate the effectiveness of the continuum modeling approach. Future directions of research on continuum modeling are identified. These include needed extensions and applications of continuum modeling as well as computational strategies and modeling techniques.


2020 ◽  
pp. 1-7

Abstract The manuscript provides the scientific society and experts involved in pain relief and patient empowerment with a good practice focused on low back pain (LBP). Such best practice is particularly relevant today, taking into account the important advancements in the fight against pain and the new context of the European Pillar of Social Rights. In particular, key principle N.17 on the “Inclusion of people with disabilities” declares that “People with disabilities have the right to income support that ensures living in dignity, services that enable them to participate in the labor market and in society, and a work environment adapted to their needs” [1]. In continuity with its long-term policy on the fight against pain, the Italian NGO Cittadinanzattiva APS [2], through its EU branch Active Citizenship Network [3] (ACN), has become an official Ambassador for the EU Social Pillar, following the invitation by the EU Commission-DG EMPL in 2020, in order to contribute to better implement the European Pillar of Social Rights for people suffering from chronic pain. This article has been written with the hope that the collection and dissemination of good practices against chronic pain, which ACN has been carried out across Europe for years, as well as the online publication of good practices by experts and committed operators, could be valued in the contest of the European Pillar of Social Rights and contribute to transfer the recent achievement on chronic pain from the European political agenda to the European culture as fast as possible.


2012 ◽  
Vol 82 (3) ◽  
pp. 209-215 ◽  
Author(s):  
Simone Bell ◽  
Heikki Pakkala ◽  
Michael P. Finglas

Food composition data (FCD) comprises the description and identification of foods, as well as their nutrient content, other constituents, and food properties. FCD are required for a range of purposes including food labeling, supporting health claims, nutritional and clinical management, consumer information, and research. There have been differences within and beyond Europe in the way FCD are expressed with respect to food description, definition of nutrients and other food properties, and the methods used to generate data. One of the major goals of the EuroFIR NoE project (2005 - 10) was to provide tools to overcome existing differences among member states and parties with respect to documentation and interchange of FCD. The establishment of the CEN’s (European Committee for Standardisation) TC 387 project committee on Food Composition Data, led by the Swedish Standards Institute, and the preparation of the draft Food Data Standard, has addressed these deficiencies by enabling unambiguous identification and description of FCD and their quality, for dissemination and data interchange. Another major achievement of the EuroFIR NoE project was the development and dissemination of a single, authoritative source of FCD in Europe enabling the interchange and update of data between countries, and also giving access to users of FCD.


2018 ◽  
pp. 10-37
Author(s):  
Barbara Curyło

In the discussion on the future of the EU, the topic of differentiated integration has become a strategic issue, with different variants beginning to appear as modus operandi of the European Union, which has become a subject of controversy among Member States. Significantly, the debate on differentiated integration began to be accompanied by reflections on disintegration. This article attempts to define disintegration on the assumption that it should be defined through the prism of integration, and that such a defining process can not be limited to concluding a one-way contrast between disintegration versus integration and vice versa. This is due to the assumption that the European Union is a dichotomous construct in which integration and disintegration mutually exclude and complement each other. This dichotomy is most evident in the definition of integration and disintegration through the prism of Europeanisation top-down and bottom-up processes that generate, reveal, visualize, stimulate integration mechanisms what allows to diagnose their determinants.


Author(s):  
Natalia Popova

The concept of Europeanization has become quite fashionable in EU studies in recent years. It is often used for the analysis of the relations between the EU and non-member states. The aim of the article is to examine the possibilities of its application in explaining the relationship between the EU and Ukraine. The structure of the article is as follows: firstly, the concept of Europeanization is defined considering such two disputable issues as distinguishing among concepts of Europeanization and European integration as well as Europeanization and EU-ization. Next, the evolution of the theoretical research of Europeanization and definition of this concept are analyzed. Two main mechanisms of Europeanization (conditionality and socialization) are examined. The author considers main approaches to the analysis of the "external" Europeanization emphasizing the concept of "external governance". Three groups of factors which influence the effectiveness of Europeanization are briefly analyzed. And finally, the peculiarities of application of the Europeanization concept to the Ukraine-EU relations are outlined. Keywords: EU, Ukraine, Europeanization, EU-ization, ‘external’ Europeanization, conditionality, socialization, concept of ‘external governance’


Sign in / Sign up

Export Citation Format

Share Document