According to the European Union regulation, some countries have established a pre-market notification system for food supplements while others have not. As this regulation is unfulfilled, a notified and marketed food supplement ingredient in one country may be forbidden in another. Even though food supplements shall not be placed on the market if unsafe, some products may still expose the consumers to risks. The risk is increased by easier access due to worldwide dissemination fostered by the internet and free movement of goods in the European Union. The Rapid Alert System for Food and Feed and the Emerging Risks Exchange Network are described. To date, the European Union legislation does not include a provision to establish a dedicated vigilance system for food supplements (Nutrivigilance). Six European Union countries have nevertheless set up national systems, which are presented. The present lack of European Union data collection harmonization, does not allow easy cooperation between countries. This article advocates for creating a coordinated European Nutrivigilance System to detect and scrutinize adverse effects of food supplements. This, to help in directing science-based risk assessments and reinforce the science-based decision of policy makers to improve public health safety.

• MeSH
• European Union MeSH
• Dietary Supplements adverse effects   MeSH
• Consumer Product Safety * MeSH
• Public Health * MeSH
• Legislation, Food MeSH
• Publication type
• Journal Article MeSH
• Review MeSH

• MeSH
• European Union MeSH
• Research MeSH
• Publication type
• Abstracts MeSH
• Geographicals
• Europe MeSH

• Conspectus
• Veřejné zdraví a hygiena
• NML Fields
• veřejné zdravotnictví
• politologie, politika, zdravotní politika

• About
• Commission of the European Communities. Biomedical and Health Research Programme Authority

• MeSH
• Epidemiologic Methods standards   MeSH
• Information Systems MeSH
• Communicable Disease Control MeSH
• Geographicals
• Europe MeSH
• Europe, Eastern MeSH

• Conspectus
• Lékařské vědy. Lékařství
• NML Fields
• management, organizace a řízení zdravotnictví
• veřejné zdravotnictví
• infekční lékařství
• NML Publication type
• publikace WHO

European Board of Urology (EBU) je sekcí European Union of Medical Specialists (UEMS). EBU se skládá z výkonného výboru, rady a jednotlivých komisí (Akreditační, zkušební, vzdělávacích programů a lidských zdrojů). Cílem EBU je harmonizace a podpora vzdělávání v urologii čehož dosahuje certifikováním vzdělávacích programů, definováním u evropského curricula urologie, pořádáním zkoušek FEBU a spoluorganizací celoživotní vzdělávání v urologii.

European Board of Urology (EBU) is section of European Union of Medical Specialists (UEMS). The EBU consists of the Management Foundation/Executive Board, the Board and of the Committees (Accreditation, Examination, Urological Training Programme and Manpower). The aim of the EBU is the harmonization and promotion of training in urology which by certifying the training programs, by defining of the European Curriculum of Urology, and by organizing the FEBU exams and co-organization of Continuing Medical Education in urology.

• Keywords
• European Union of Medical Specialists,
• MeSH
• Curriculum standards   MeSH
• Professional Competence standards   MeSH
• Societies, Medical organization & administration   trends   MeSH
• Education, Medical, Graduate methods   organization & administration   MeSH
• Urology MeSH
• Publication type
• Review MeSH
• Geographicals
• Europe MeSH

• MeSH
• Electronic Health Records MeSH
• Information Systems * organization & administration   MeSH
• Internet * MeSH
• Medical Informatics Computing * MeSH
• Humans MeSH
• Vocabulary, Controlled MeSH
• Systematized Nomenclature of Medicine MeSH
• Terminology as Topic * MeSH
• Information Storage and Retrieval MeSH
• Check Tag
• Humans MeSH
• Publication type
• Research Support, Non-U.S. Gov't MeSH

Úmluva o lidských právech a biomedicíně, vypracovaná v rámci Rady Evropy a předložená k podpisu r. 1997, představuje bezprecedentní pokus sjednotit základní východiska evropského zdravotního práva. Cílem Úmluvy je uvést do souladu ochranu lidských práv a důstojnosti lidských bytostí s rozvojembiomedicínských oborů. Úmluva zevrubně definuje práva a ochranu důstojnosti lidských bytostí při provádění zákroků ve zdravotní oblasti včetně vědeckého výzkumu. Smluvní státy jsou povinny přijmout opatření, kterými bude ve vnitrostátních právních řádech zajištěna účinnost ustanovení Úmluvy.Úmluvumá doplnit soubor dodatkových protokolů, z nichž byly dosud schváleny protokol o zákazu klonování lidských bytostí a protokol o transplantační medicíně. Úmluva, jež by měla být pravidelně přehodnocována, má potenciál stát se pevným, dlouhodobým základem pro řešení závažných právně-etických problémů vyvolaných pokroky biomedicíny. Nevypořádává se ovšem se všemi problémovými oblastmi a mezi jejími signatáři chybí některé přední evropské vědecko-průmyslové mocnosti (Německo, Spojené království).

The Convention on Human Rights and Biomedicine, prepared under the auspices of the Council of Europe and opened for signature in 1997, is an unprecendeted attempt to unify basic points of departure of European health law. The Convention aims at harmonizing the protection of human rights and the dignity of human beings with the dynamic development of biomedical disciplines. The Convention comprehensively defines fundamental human rights and protection of the dignity of human beings within the context of intervention in the health area including the scientific research. The signatory states are obliged to adopt such measures which will give effect to the provisions of the Convention in their internal legal systems. The Convention should be followed by a series of additional protocols; protocol on prohibition of cloning of human beings and on transplantation medicine have been hitherto approved. The Convention which should be reviewed at regular intervals, has the potential to become stable, long-term basis for dealing with serious legal and ethical problems resulting from the progress of biomedicine. Nevertheless, the Convention does no address all the problems and, in particular, some foremost European scientific powers are missing from the list of its signatories (Germany, the United Kingdom).

• MeSH
• European Union MeSH
• Medicine MeSH
• Human Rights MeSH
• Legislation, Medical MeSH

BACKGROUND: In spite of recent major advances in the understanding and treatment of inhibitor development in patients with haemophilia, multidisciplinary management of many of these patients remains suboptimal and highly heterogenous across Europe. METHODS: Following a series of multidisciplinary meetings and a review of the literature, the European haemophilia community of health professionals and patients jointly defined practical optimum standards for ensuring and harmonizing treatment and care for patients with an inhibitor. RESULTS: Ten complementary principles for the management of inhibitors in haemophilia have been developed, emphasizing the importance and benefits of a centralized, multidisciplinary, expert and holistic approach. CONCLUSIONS: This document will serve as a benchmark to improve the multidisciplinary and practical management of patients with inhibitor. Implementation and adherence to each of these principles should have a major positive impact on the management and outcomes of patients developing an inhibitor.

• MeSH
• Factor IX metabolism   MeSH
• Factor VIII metabolism   MeSH
• Hemophilia A metabolism   MeSH
• Humans MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH
• Geographicals
• Europe MeSH

BACKGROUND: Myasthenia gravis (MG) is a rare autoimmune disorder. Several new treatment concepts have emerged in recent years, but access to these treatments varies due to differing national reimbursement regulations, leading to disparities across Europe. This highlights the need for high-quality data collection by stakeholders to establish MG registries. A European MG registry could help bridge the treatment access gap across different countries, offering critical data to support regulatory decisions, foster international collaborations, and enhance clinical and epidemiological research. Several national MG registries already exist or are in development. To avoid duplication and ensure harmonization in data collection, a modified Delphi procedure was implemented to identify essential data elements for inclusion in national registries. RESULTS: Following a literature review, consultations with patient associations and pharmaceutical companies, and input from multiple European MG experts, 100 data elements were identified. Of these, 62 reached consensus for inclusion and classification, while only 1 item was agreed for exclusion. 30 items failed to reach the ≥ 80% agreement threshold and were excluded. Among the 62 accepted items, 21 were classified as mandatory data elements, 32 optional, and 9 items pertained to the informed consent form. CONCLUSIONS: Through a modified Delphi procedure, consensus was successfully achieved. This consensus-based approach represents a crucial step toward harmonizing MG registries across Europe. The resulting dataset will facilitate the sharing of knowledge and enhance European collaborations. Furthermore, the harmonized data may assist in regulatory or reimbursement decisions regarding novel therapies, as well as address treatment access disparities between European countries.

• MeSH
• Delphi Technique * MeSH
• Consensus MeSH
• Humans MeSH
• Myasthenia Gravis * therapy   diagnosis   MeSH
• Registries * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Geographicals
• Europe MeSH

Patient safety is a leading challenge in healthcare and from the laboratory perspective it is now well established that preanalytical errors are the major contributor to the overall rate of diagnostic and therapeutic errors. To address this, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase (EFLM WG-PRE) was established to lead in standardization and harmonization of preanalytical policies and practices at a European level. One of the key activities of the WG-PRE is the organization of the biennial EFLM-BD conference on the preanalytical phase to provide a forum for National Societies (NS) to discuss their issues. Since 2012, a year after the first Preanalytical phase conference, there has been a rapid growth in the number of NS with a working group engaged in preanalytical phase activities and there are now at least 19 countries that have one. As a result of discussions with NS at the third conference held in March 2015 five key areas were identified as requiring harmonisation. These were test ordering, sample transport and storage, patient preparation, sampling procedures and management of unsuitable specimens. The article below summarises the work that has and will be done in these areas. The goal of this initiative is to ensure the EFLM WG-PRE produces work that meets the needs of the European laboratory medicine community. Progress made in the identified areas will be updated at the next preanalytical phase conference and show that we have produced guidance that has enhanced standardisation in the preanalytical phase and improved patient safety throughout Europe.

• MeSH
• Blood Chemical Analysis standards   MeSH
• Chemistry, Clinical organization & administration   standards   MeSH
• Humans MeSH
• Reference Standards MeSH
• Practice Guidelines as Topic MeSH
• Societies, Medical MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH
• Geographicals
• Europe MeSH

Liver transplantation (LT) is a rescue therapy for life-threatening complications of Wilson's disease (WD). However, data on the outcome of WD patients after LT are scarce. The aim of our study was to analyze a large pediatric WD cohort with the aim of investigating the longterm outcome of pediatric WD patients after LT and to identify predictive factors for patient and transplant survival. This is a retrospective cohort study using data of all children (<18 years) transplanted for WD enrolled in the European Liver Transplant Registry from January 1968 until December 2013. In total, 338 patients (57.6% female) transplanted at 80 different European centers (1-26 patients per center) were included in this study. The median age at transplantation was 14.0 years (interquartile range [IQR], 11.2-16.1 years); patients were followed up for a median of 5.4 years (IQR, 1.0-10.9 years) after LT. Overall patient survival rates were high with 87% (1-year survival), 84% (5-year survival), and 81% (10-year survival); survival rates increased considerably with the calendar year (P < 0.001). Early age at LT, living donation, and histidine tryptophan ketoglutarate preservation liquid were identified as risk factors for poor patient survival in the multivariate analysis. LT is an excellent treatment option for pediatric patients with WD and associated end-stage liver disease. Longterm outcome in these patients is similar to other pediatric causes for LT. Overall patient and graft survival rates improved considerably over the last decades. To improve future research in the field, the vast variability of allocation strategies should be harmonized and a generally accepted definition or discrimination of acute versus chronic WD needs to be found.

• MeSH
• Time Factors MeSH
• Healthcare Disparities MeSH
• Child MeSH
• Hepatolenticular Degeneration diagnosis   mortality   surgery   MeSH
• End Stage Liver Disease diagnosis   mortality   surgery   MeSH
• Humans MeSH
• Adolescent MeSH
• Cause of Death MeSH
• Registries MeSH
• Retrospective Studies MeSH
• Risk Factors MeSH
• Liver Transplantation * adverse effects   mortality   MeSH
• Age Factors MeSH
• Treatment Outcome MeSH
• Check Tag
• Child MeSH
• Humans MeSH
• Adolescent MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Geographicals
• Europe MeSH