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  • 1.
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    Étude de faisabilité concernant la mise en place d’un système d’analyse par substance active (monographies) et d’autres options possibles pour l’évaluation des risques pour l’environnement des médicaments vétérinaires [er] : résumé. European Commission. Directorate-General for Health and Food Safety.
    Publication
    Luxembourg : Publications Office, 2021.
    Summary
    L’objectif de cette étude était d’évaluer la faisabilité de la mise en place d’un système d’analyse par substance active (monographies) et d’autres options possibles pour l’évaluation des risques pour l’environnement des médicaments vétérinaires. Le « système de monographie » et deux alternatives ont été examinés quant à leur impact éventuel ainsi qu'à leur efficacité pour atteindre les objectifs du RMV : réduire la charge administrative, renforcer le marché intérieur, améliorer la disponibilité des MV, tout en garantissant le plus haut niveau de protection de la santé publique et animale et de l'environnement. Les résultats de cette étude de faisabilité serviront à la Commission pour préparer un rapport au Parlement européen et au Conseil examinant la pertinence et la faisabilité du passage à un système d'analyse par substance (au lieu du système actuel d'analyse centré sur les produits) et proposant des options pour des mesures politiques supplémentaires.
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  • 2.
    book.ebook
    Studie zur Machbarkeit eines wirkstoffbasierten Prüfungs-systems (‘Monographien’) und anderer denkbarer Alternativen zur Umwelt verträglichkeitsprüfung von Tierarzneimitteln [er] : Zusammenfassung. European Commission. Directorate-General for Health and Food Safety.
    Publication
    Luxembourg : Publications Office, 2021.
    Summary
    Ziel der vorliegenden Studie war es, die Machbarkeit eines wirkstoffbasierten Ansatzes („Monographiesystem") und anderer möglicher Alternativen zur UVP von TAM zu bewerten. Das „Monographiesystem“ sowie zwei Alternativen wurden im Hinblick auf mögliche Auswirkungen sowie ihre Effizienz und Effektivität zur Erreichung der in der TAM-Verordnung definierten Ziele untersucht: Verringerung des Verwaltungsaufwands, Weiterentwicklung des Binnenmarktes, Verbesserung der Verfügbarkeit von TAM bei gleichzeitiger Gewährleistung des höchsten Maßes an Schutz der Gesundheit von Mensch und Tier und der Umwelt. Die Ergebnisse dieser Machbarkeitsstudie sollen die Kommission bei der Erstellung eines Berichts an das Europäische Parlament und den Rat unterstützen, in dem die Zweckmäßigkeit und Machbarkeit der Umstellung auf ein wirkstoffbasiertes Prüfungssystem (anstelle des derzeitigen produktorientierten Prüfungssystems) untersucht und Optionen für weitere politische Maßnahmen vorgeschlagen werden sollen.
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  • 3.
    book.ebook
    Feasibility study of an active-substance-based review system (‘monographs’) and other potential alternatives for the environmental risk assessment of veterinary medicinal products [er] : final report. European Commission. Directorate-General for Health and Food Safety.
    Publication
    Luxembourg : Publications Office, 2021.
    Summary
    Both scientific and policy discussions have been ongoing for several years on the shortcomings of the current product-based environmental risk assessment of veterinary medicinal products in the EU, and the nature of potential alternatives. The present study identified, collected and analysed information to assess the feasibility of an active-substance-based approach (‘monograph system’) and other potential alternatives. The monograph system as defined in the literature, and two alternatives presented by Animal Health Europe and the European Group for Generic Veterinary Products were examined for their possible impacts, efficiency and effectiveness in achieving the objectives of Regulation (EU) 2019/06, i.e. reduce the administrative burden, enhance the internal market, increase the availability of VMPs, while guaranteeing the highest level of public and animal health and protection of the environment. In an initial phase the monograph system would be more expensive and resource-intensive, but in the long-term the benefits should overbalance the disadvantages. In addition, a number of suggestions were developed to improve the acceptability of the monograph system. The benefit would be enhanced by using existing tools and experiences from other regulatory frameworks. Moreover, it would support current EU strategic approaches, such as the “one substance, one assessment” approach of the European Green Deal (COM/2019/640). Especially in view of these EU goals, a monograph system is justified, proportionate and may be affordable in a long-time perspective.
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  • 4.
    book.ebook
    Feasibility study of an active-substance-based review system (‘monographs’) and other potential alternatives for the environmental risk assessment of veterinary medicinal products [er] : executive summary. European Commission. Directorate-General for Health and Food Safety.
    Publication
    Luxembourg : Publications Office, 2021.
    Summary
    The objective of the present study was to assess the feasibility of an active-substance-based approach (“monograph system”) and that of other potential alternatives for environmental risk assessment of veterinary medicinal products. The “monograph system” and two alternatives were examined with regard to their possible impacts as well as their efficiency and effectiveness in achieving the objectives of the VMPR: reduce the administrative burden, enhance the internal market, increase the availability of VMPs, while guaranteeing the highest level of public and animal health and protection of the environment. The outcome of this feasibility study shall assist the Commission in preparing a report to the European Parliament and Council examining the appropriateness and practicability of moving to a substance-based review system (instead of the current product-oriented review system) and proposing options for further policy action.
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  • 5.
    book.ebook
    Европейский доклад о наркотиках 2021 г. [er] : тенденции и развития. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    Luxembourg : Publications Office, 2021.
    Summary
    В докладе «тенденции и изменения» представлен общий обзор ситуации с наркотиками в Европе. Уделяя основное внимание проблеме незаконного употребления наркотиков, связанного с этим вреда для здоровья и поставке наркотиков, доклад содержит обширную базу национальных данных по вышеперечисленным вопросам и ключевым вмешательствам по снижению вреда.
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  • 6.
    book
    Европейский доклад о наркотиках 2021 г. : тенденции и развития. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    Luxembourg : Publications Office, 2021.
    Summary
    В докладе «тенденции и изменения» представлен общий обзор ситуации с наркотиками в Европе. Уделяя основное внимание проблеме незаконного употребления наркотиков, связанного с этим вреда для здоровья и поставке наркотиков, доклад содержит обширную базу национальных данных по вышеперечисленным вопросам и ключевым вмешательствам по снижению вреда.
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  • 7.
    book.ebook
    EU health data centre and a common data strategy for public health [er]. European Parliament. Directorate-General for Parliamentary Research Services.
    Publication
    Luxembourg : Publications Office, 2021.
    Summary
    Regarding health data, its availability and comparability, the Covid-19 pandemic revealed that the EU has no clear health data architecture. The lack of harmonisation in these practices and the absence of an EU-level centre for data analysis and use to support a better response to public health crises is the focus of this study. Through extensive desk review, interviews with key actors, and enquiry into experiences from outside the EU/EEA area, this study highlights that the EU must have the capacity to use data very effectively in order to make data-supported public health policy proposals and inform political decisions. The possible functions and characteristics of an EU health data centre are outlined. The centre can only fulfil its mandate if it has the power and competency to influence Member State public-health-relevant data ecosystems and institutionally link with their national level actors. The institutional structure, its possible activities and in particular its usage of advanced technologies such as AI are examined in detail.
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  • 8.
    book.ebook
    Das Recht auf Gesundheit, eine rechtsvergleichende Perspektive [er] : Deutschland. European Parliament. Directorate-General for Parliamentary Research Services.
    Publication
    [Brussels] : European Parliament, [2021], c2021.
    Summary
    Dieses Dokument ist Teil einer Reihe von Studien, mit denen das Recht auf Gesundheit in verschiedenen Staaten aus rechtsvergleichender Sicht dargestellt werden soll. Nach einer Erklärung der einschlägigen Rechtsvorschriften und Rechtsprechung werden der Inhalt, die Grenzen und die mögliche Entwicklung dieses Rechts analysiert. Die vorliegende Studie hat den Fall Deutschland zum Gegenstand. Ein „Recht auf Gesundheit“ ist dem deutschen Verfassungsrecht fremd. Das „Recht auf Leben und körperliche Unversehrtheit“ nach Art. 2 Abs. 2 Satz 1 Grundgesetz schützt nicht die Gesundheit als solche. Allerdings ist dieses Grundrecht, das zunächst ein Abwehrrecht gegen staatliche Eingriffe darstellte, durch das Bundesverfassungsgericht auch in seiner Schutzpflichtdimension entfaltet worden. Danach gebietet das Grundrecht dem Staat, sich schützend und fördernd vor das menschliche Leben zu stellen. Unabhängig von den verfassungsrechtlichen Determinanten hat sich seit der Bismarckschen Sozialgesetzgebung mit dem Sozialgesetzbuch, ferner durch das Infektionsschutzgesetz und zahlreiche weitere Kodifikationen ein umfangreiches einfachgesetzliches Gesundheitsrecht gebildet.
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  • 9.
    book
    Das Recht auf Gesundheit, eine rechtsvergleichende Perspektive : Deutschland. European Parliament. Directorate-General for Parliamentary Research Services.
    Publication
    [Brussels] : European Parliament, [2021], c2021.
    Summary
    Dieses Dokument ist Teil einer Reihe von Studien, mit denen das Recht auf Gesundheit in verschiedenen Staaten aus rechtsvergleichender Sicht dargestellt werden soll. Nach einer Erklärung der einschlägigen Rechtsvorschriften und Rechtsprechung werden der Inhalt, die Grenzen und die mögliche Entwicklung dieses Rechts analysiert. Die vorliegende Studie hat den Fall Deutschland zum Gegenstand. Ein „Recht auf Gesundheit“ ist dem deutschen Verfassungsrecht fremd. Das „Recht auf Leben und körperliche Unversehrtheit“ nach Art. 2 Abs. 2 Satz 1 Grundgesetz schützt nicht die Gesundheit als solche. Allerdings ist dieses Grundrecht, das zunächst ein Abwehrrecht gegen staatliche Eingriffe darstellte, durch das Bundesverfassungsgericht auch in seiner Schutzpflichtdimension entfaltet worden. Danach gebietet das Grundrecht dem Staat, sich schützend und fördernd vor das menschliche Leben zu stellen. Unabhängig von den verfassungsrechtlichen Determinanten hat sich seit der Bismarckschen Sozialgesetzgebung mit dem Sozialgesetzbuch, ferner durch das Infektionsschutzgesetz und zahlreiche weitere Kodifikationen ein umfangreiches einfachgesetzliches Gesundheitsrecht gebildet.
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  • 10.
    book.ebook
    Co-ordinated approach to the development and supply of radionuclides in the EU [er] : final report. European Commission. Directorate-General for Energy.
    Publication
    Luxembourg : Publications Office, 2021.
    Edition
    First edition.
    Summary
    The objective of the present study was to fill gaps in the available information on the supply chains for the main established and novel radionuclides that have, or are expected to have, significant uses in Europe. The work also had the goal of preparing the ground for long-term European co-operation in this area. The study had to meet the following specific objectives: a. identify the main radionuclides currently in use in the European Union, and the main radionuclides expected to be used by 2030, with a particular focus on the radionuclides used in medicine; b. identify the existing and emerging methods and technologies for production of the radionuclides covered under (a) and fully describe the main elements of their respective supply chains; c. identify the main suppliers of source materials and technologies for production of radionuclides covered under (a) and the facilities which are part of the above supply chains; d. develop scenarios and concrete options for sustainable and secure supply of radionuclides covered under (a) in the EU.
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  • 11.
    book.ebook
    Guidance on information requirements and chemical safety assessment [er] : Appendix R7-1 for nanomaterials applicable to Chapter R7a Endpoint specific guidance. European Chemicals Agency.
    Publication
    Helsinki : ECHA, [2021], c2021.
    Summary
    Three appendices concerning information requirements (appendices to IR&CSA Guidance Chapters R7a, R7b and R7c) have been developed in order to provide advice to registrants for use when preparing REACH registration dossiers that cover “nanoforms”. The advice provided in this document focuses on specific recommendations for testing materials that are nanoforms of substances. As most of the guidelines and publications are referring to nanomaterials or nanoparticles, also the terms ‘nanomaterial’ and ‘nanoparticle’ are used. Annex VI defines the terms “nanoform” and “set of similar nanoforms” and establishes the requirements for characterisation of the identified nanoforms/sets of similar nanoforms of the substance. A glossary is available to clarify the proper meaning of the terms used in the guidance. Part of the advice provided is not strictly nanoform specific and may for instance also be applicable to other particulate forms of substances (e.g., relevance of dissolution rate). However, when such advice has been included, it is because it is considered especially relevant for nanoforms and should be part of the nanoform specific guidance. In the absence of availability of any suitable specific provision (either because the endpoint is not relevant for nanoforms, because the guidance already provided is considered to be equally applicable to nanoforms as to non-nanoforms, or because more research or adaptation is needed before developing advice) no additional guidance for the information requirement has been included in this appendix. This appendix intends to provide advice specific to nanoforms and does not preclude the applicability of the general principles given in Chapter R.7a [1] (i.e. the parent guidance). Moreover, when no advice has been given in this appendix for a specific endpoint the advice provided in the parent Guidance should be followed. Please note that this document (and its parent guidance) provides specific guidance on meeting the information requirements set out in Annexes VI to XI to the REACH Regulation. General information for meeting the information requirements such as collection and evaluation of available information, and adaptation of information requirements is available in Chapter R.2 to R.5 of Guidance on IR&CSA. Moreover, when considering the use of data already available, “Guidance on information requirements and chemical safety assessment – Appendix R.6-1 for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals” [2] may be useful as it provides an approach on how to read-across the hazard data between nanoforms (and the non-nanoform) of the same substance.
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  • 12.
    book.ebook
    Action framework for developing and implementing health and social responses to drug problems [er]. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    [Lisbon] : [EMCDDA], [2021]
    Summary
    The action framework introduced here will help to clarify current thinking about the response process and the factors to take into account at each stage. This will be of particular interest to those planning health and social policy or interventions to address drug problems, but can equally apply to responses at the individual level. It also provides a structure to the different miniguides which, together, make up the Health and social responses to drug problems: a European guide 2021.
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  • 13.
    book.ebook
    New psychoactive substances [er] : health and social responses. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    [Lisbon] : [EMCDDA], [2021]
    Summary
    This miniguide is one of a larger set, which together comprise Health and social responses to drug problems: a European guide 2021. The guide supports practitioners and policymakers in tackling the negative consequences of drug use. The new psychoactive substances miniguide provides an overview of the most important aspects to consider when planning or delivering health and social responses to problems related to new psychoactive substances, and reviews the availability and effectiveness of the responses. It also considers implications for policy and practice.
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  • 14.
    book.ebook
    Polydrug use [er] : health and social responses. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    [Lisbon] : [EMCDDA], [2021]
    Summary
    This miniguide is one of a larger set, which together comprise Health and social responses to drug problems: a European guide 2021. The guide supports practitioners and policymakers in tackling the negative consequences of drug use. This polydrug miniguide provides an overview of the most important aspects to consider when planning or delivering health and social responses to problems related to polydrug use, and reviews the availability and effectiveness of the responses. It also considers implications for policy and practice.
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  • 15.
    book.ebook
    Opioids [er] : health and social responses. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    [Lisbon] : [EMCDDA], [2021]
    Summary
    This miniguide is one of a larger set, which together comprise Health and social responses to drug problems: a European guide 2021. The guide supports practitioners and policymakers in tackling the negative consequences of drug use.The opioids miniguide provides an overview of the most important aspects to consider when planning or delivering health and social responses to opioid-related problems, and reviews the availability and effectiveness of the responses. It also considers implications for policy and practice.
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  • 16.
    book.ebook
    Cannabis [er] : health and social responses. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    [Lisbon] : [EMCDDA], [2021]
    Summary
    This miniguide is one of a larger set, which together comprise Health and social responses to drug problems: a European guide 2021. The guide supports practitioners and policymakers in tackling the negative consequences of drug use. This cannabis miniguide provides an overview of the most important aspects to consider when planning or delivering health and social responses to cannabis-related problems, and reviews the availability and effectiveness of the responses. It also considers implications for policy and practice.
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  • 17.
    book.ebook
    Stimulants [er] : health and social responses. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    [Lisbon] : [EMCDDA], [2021]
    Summary
    This miniguide is one of a larger set, which together comprise Health and social responses to drug problems: a European guide 2021. The guide supports practitioners and policymakers in tackling the negative consequences of drug use. The stimulants miniguide provides an overview of what to consider when planning or delivering health and social responses to stimulant-related problems, and reviews the available interventions and their effectiveness. It also considers implications for policy and practice.
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  • 18.
    book.ebook
    Non-medical use of medicines [er] : health and social responses. European Monitoring Centre for Drugs and Drug Addiction.
    Publication
    [Lisbon] : [EMCDDA], [2021]
    Summary
    This miniguide is one of a larger set, which together comprise Health and social responses to drug problems: a European guide 2021. The guide supports practitioners and policymakers in tackling the negative consequences of drug use. This miniguide on non-medical use of medicines provides an overview of the most important aspects to consider when planning or delivering health and social responses to problems related to the non-medical use of medicines, and reviews the availability and effectiveness of the responses. It also considers implications for policy and practice.
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  • 19.
    book.ebook
    The EU and the Coronavirus pandemic [er]. European Commission. Directorate-General for Communication.
    Publication
    Luxembourg : Publications Office, 2021.
    Summary
    The present volume analyses European citizens’ views on the coronavirus pandemic. Covid-19 is a coronavirus, which surfaced in Wuhan, China in December 2019, and has spread throughout the world. The World Health Organization has declared the situation a pandemic. Since 31 December 2019 and as of 8 April 2021, more than 131 million cases have been reported, including more than 2.8 million deaths. There were more than 44 million reported cases in Europe at this time, including around 971,000 deaths. The European Union has been working to contain the spread of the coronavirus, support national health systems, protect and save lives, and counter the socio-economic impacts of the pandemic at both national and EU level. In May 2020, the European Commission proposed a revamped long-term EU budget boosted by ‘NextGenerationEU’, an emergency recovery instrument, aimed to help repair the immediate economic and social damage brought by the coronavirus pandemic, kickstart the recovery and prepare for a better future for the next generation. This was endorsed by the EU heads of state or government in July 2020, and the agreement was sealed with the European Parliament in November 2020, with final adoption of the 2021-2027 package by the Council of the European Union in December 2020.
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  • 20.
    book.ebook
    L’UE et la pandémie de coronavirus [er]. European Commission. Directorate-General for Communication.
    Publication
    [Brussels] : European Commission, [2021], c2021.
    Summary
    Le présent volume porte sur l’opinion des citoyens européens à l’égard de la pandémie de coronavirus. La Covid-19 est un coronavirus qui est apparu à Wuhan en Chine en décembre 2019 et qui s’est propagé dans le monde entier. L’Organisation mondiale de la santé a qualifié la situation de pandémie. Entre le 31 décembre 2019 et le 8 avril 2021, plus de 131 millions de personnes ont été contaminées, et le bilan s’élève à plus de 2,8 millions de décès. En Europe, plus de 44 millions de cas ont été recensés à ce jour, et on déplore environ 971 000 décès. L’Union européenne s’est efforcée d’endiguer la propagation du coronavirus, de soutenir les systèmes de santé nationaux, de protéger et de sauver des vies, ainsi que d’atténuer les répercussions socioéconomiques de la pandémie au niveau national et européen. En mai 2020, la Commission européenne a proposé le réaménagement du budget européen à long terme en s’appuyant sur l’instrument de relance d’urgence « NextGenerationEU » dont l’objectif est de contribuer à remédier aux conséquences économiques et sociales immédiates de la pandémie de coronavirus, stimuler la reprise et préparer un avenir meilleur pour la génération future. Ce plan a été approuvé par les chefs d’État et de gouvernement de l’UE en juillet 2020 et l’accord a été entériné par le Parlement européen en novembre 2020 dans le cadre de l’adoption définitive du Cadre financier pluriannuel 2021-2027 par le Conseil de l’Union européenne en décembre 2020
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