Does the development of new medicinal products in the European Union address global and regional health concerns?

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Álvarez-Martín Elena

2010-12-01

Full Text Available Abstract Background Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective. Methods We reviewed the information on new medicinal products approved by centralized procedure from 1995 to 2009, information that is available to the public in the European Commission Register of medicinal products and the European Public Assessment Reports from the European Medicines Agency. Morbidity and mortality data were included for each disease group, according to the Global Burden of Disease project. We evaluated the association between authorized medicinal products and burden of disease measures based on disability-adjusted life years (DALYs in the European Union and worldwide. Results We considered 520 marketing authorizations for medicinal products and 338 active ingredients. New authorizations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal product development (ρ = 0.619, p = 0.005 in the European Union, and a moderate correlation for middle-low-income countries (ρ = 0.497, p = 0.030 and worldwide (ρ = 0.490, p = 0.033. The most neglected conditions at the European level (based on their attributable health losses were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions, and digestive diseases, while globally, they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, and digestive diseases. Conclusions We find that the development of new medicinal products is higher for some diseases than others. Pharmaceutical industry leaders and policymakers are invited to consider the implications of this

Traditional Mediterranean and European herbal medicines.

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Leonti, Marco; Verpoorte, Robert

2017-03-06

Written history allows tracing back Mediterranean and European medical traditions to Greek antiquity. The epidemiological shift triggered by the rise of modern medicine and industrialization is reflected in contemporary reliance and preferences for certain herbal medicines. We sketch the development and transmission of written herbal medicine through Mediterranean and European history and point out the opportunity to connect with modern traditions. An ethnopharmacological database linking past and modern medical traditions could serve as a tool for crosschecking contemporary ethnopharmacological field-data as well as a repository for data mining. Considering that the diachronic picture emerging from such a database has an epidemiological base this could lead to new hypotheses related to evolutionary medicine. The advent of systems pharmacology and network pharmacology opens new perspectives for studying past and current herbal medicine. Since a large part of modern drugs has its roots in ancient traditions one may expect new leads for drug development from novel systemic studies, as well as evidence for the activity of certain herbal preparations. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

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Regnstrom, Jan; Koenig, Franz; Aronsson, Bo; Reimer, Tatiana; Svendsen, Kristian; Tsigkos, Stelios; Flamion, Bruno; Eichler, Hans-Georg; Vamvakas, Spiros

2010-01-01

To identify factors associated with success of Market Authorisation Applications (MAAs) for pharmaceutical drugs submitted to the European Medicines Agency (EMEA), with an emphasis on the Scientific Advice (SA) given by the Committee for Human Medicinal Products (CHMP). MAAs with a CHMP decision (outcome) between 1 January 2004 and 31 December 2007 were included in the analysis. Factors evaluated were: company size, orphan drug (OD) status, product type, existence of SA, compliance with SA, therapeutic area and year of outcome. Compliance with SA was retrospectively assessed with reference to three critical clinical variables in pivotal studies: choice of primary endpoint, selection of control and statistical methods. Of 188 MAAs with an outcome, 137 (72.9%) were approved, whereas 51 (27.1%) were not approved or were withdrawn by the company. In the simple logistic regression analysis, company size [odds ratio (OR) 2.96, 95% confidence interval (CI) 1.92; 4.56, p related to one or more of the three critical variables. Thirty-nine of these were assessed as being compliant with SA. Obtaining an SA per se was not associated with outcome (SA vs. no-SA: OR 0.96, 95% CI 0.49; 1.88, p = 0.92), but complying with SA was significantly associated with positive outcome (compliant with SA vs. no-SA: OR 14.71, 95% CI 1.95; 111.2; non-compliant with SA vs. no-SA: OR 0.17, 95% CI 0.06; 0.47, p Factors related to compliance with SA were company size and OD status (25, 60 and 84% for small, medium-sized, and large companies, respectively; 77 and 38% for non-OD and OD status, respectively). The strong association between company size and outcome suggests that resources and experience in drug development and obtaining regulatory approval are critical factors for a successful MAA. In addition, obtaining and complying with SA appears to be a predictor of outcome. Based on this analysis, companies, particularly smaller ones and those developing orphan drugs, are recommended to engage in

The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia

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Rose K

2015-11-01

Full Text Available Klaus Rose,1,* Philip D Walson,2,* 1klausrose Consulting, Pediatric Drug Development and More, Riehen, Switzerland; 2Department of Clinical Pharmacology, University Medical School, Goettingen, Germany *These authors contributed equally to this work Background: Although the diagnosis of childhood leukemia is no longer a death sentence, too many patients still die, more with acute myeloid leukemia than with acute lymphoblastic leukemia. The European Union pediatric legislation was introduced to improve pharmaceutical treatment of children, but some question whether the European Medicines Agency (EMA approach is helping children with leukemia. Some have even suggested that the decisions of EMA pediatric committee (PDCO are counterproductive. This study was designed to investigate the impact of PDCO-issued pediatric investigation plans (PIPs for leukemia drugs.Methods: All PIPs listed under “oncology” were downloaded from the EMA website. Non-leukemia decisions including misclassifications, waivers (no PIP, and solid tumors were discarded. The leukemia decisions were analyzed, compared to pediatric leukemia trials in the database http://www.clinicaltrials.gov, and discussed in the light of current literature.Results: The PDCO leukemia decisions demand clinical trials in pediatric leukemia for all new adult drugs without prioritization. However, because leukemia in children is different and much rarer than in adults, these decisions have resulted in proposed studies that are scientifically and ethically questionable. They are also unnecessary, since once promising new compounds are approved for adults, more appropriate, prioritized pediatric leukemia trials are initiated worldwide without PDCO involvement.Conclusion: EMA/PDCO leukemia PIPs do little to advance the treatment of childhood leukemia. The unintended negative effects of the flawed EMA/PDCO's standardized requesting of non-prioritized testing of every new adult leukemia drug in

[Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].

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Jost, Nils; Schüssler-Lenz, Martina; Ziegele, Bettina; Reinhardt, Jens

2015-11-01

The aim of scientific advice is to support pharmaceutical developers in regulatory and scientific questions, thus facilitating the development of safe and efficacious new medicinal products. Recent years have shown that the development of advanced therapy medicinal products (ATMPs) in particular needs a high degree of regulatory support. On one hand, this is related to the complexity and heterogeneity of this group of medicinal products and on the other hand due to the fact that mainly academic research institutions and small- and medium-sized enterprises (SMEs) are developing ATMPs. These often have limited regulatory experience and resources. In 2009 the Paul-Ehrlich-Institut (PEI) initiated the Innovation Office as a contact point for applicants developing ATMPs. The mandate of the Innovation Office is to provide support on regulatory questions and to coordinate national scientific advice meetings concerning ATMPs for every phase in drug development and especially with view to the preparation of clinical trial applications. On the European level, the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicinal Agency (EMA) offers scientific advice. This article describes the concepts of national and EMA scientific advice concerning ATMPs and summarizes the experience of the last six years.

The European Medicines Agency review of Tegafur/Gimeracil/Oteracil (Teysuno™) for the treatment of advanced gastric cancer when given in combination with cisplatin: summary of the Scientific Assessment of the Committee for medicinal products for human use (CHMP).

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Matt, Petra; van Zwieten-Boot, Barbara; Calvo Rojas, Gonzalo; Ter Hofstede, Hadewych; Garcia-Carbonero, Rocio; Camarero, Jorge; Abadie, Eric; Pignatti, Francesco

2011-01-01

The product Teysuno™ (S-1) contains tegafur, a prodrug of 5-fluorouracil (5-FU), and two modulators of 5-FU metabolism, gimeracil and oteracil. The main clinical study in this application was a randomized controlled study comparing S-1 plus cisplatin with 5-FU plus cisplatin. In this study, median overall survival times of 8.6 months and 7.9 months for S-1 plus cisplatin and 5-FU plus cisplatin, respectively, were observed (hazard ratio, 0.92; 95% confidence interval, 0.80-1.05). The Committee for Medicinal Products for Human Use of the European Medicines Agency concluded that S-1 in combination with cisplatin (75 mg/m²) was noninferior to 5-FU plus cisplatin (100 mg/m²) in patients with advanced gastric cancer and adopted a positive opinion recommending the marketing authorization for this product for the treatment of advanced gastric cancer when given in combination with cisplatin. The recommended dose of S-1 is 25 mg/m² (expressed as tegafur content) twice a day, for 21 consecutive days followed by 7 days rest (one treatment cycle), in combination with 75 mg/m² cisplatin i.v. administered on day 1. This treatment cycle is repeated every 4 weeks. The most common side effects reported in the pivotal study were anemia, neutropenia, vomiting, diarrhea, abdominal pain, weight decrease, anorexia, and fatigue. The objective of this paper is to summarize the scientific review of the application leading to approval in the EU. The full scientific assessment report and the summary of product characteristics are available on the European Medicines Agency website (http://www.ema.europa.eu).

The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports

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Schroll, Jeppe Bennekou; Abdel-Sattar, Maher; Bero, Lisa

2015-01-01

OBJECTIVES: To compare the accessibility, comprehensiveness, and usefulness of data available from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) drug reports. STUDY DESIGN AND SETTING: This is a cross-sectional study. All new molecular drugs approved between January...... 1, 2011 and December 31, 2012 from the FDA and EMA Web sites were eligible. RESULTS: We included 27 drug reports. Most were searchable, but the FDA table of contents did not match the file's page numbers. Several FDA documents must be searched compared with a single EMA document, but the FDA reports...... contain more summary data on harms. Detailed information about harms was reported for 93% of the FDA reports (25 of 27 reports) and 26% of the EMA reports (7 of 27 reports). The reports contained information about trial methodology but did not include trial registry IDs or investigator names. All reports...

Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee--adolescents' melanoma as a paradigm.

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Rose, Klaus; Senn, Stephen

2014-01-01

The European Medicines Agency (EMA) website lists all diseases that officially exist in adults only. The class waiver for juvenile melanoma was revoked in 2008 referring to US SEER statistics. This statistical justification is misleading. Melanoma in adolescents is much rarer than claimed by EMA/Paediatric Committee; < 1 ∕ 4 of adolescents with melanoma need systemic treatment; separate efficacy studies are neither medically justified nor feasible. The scarce adolescent patients should be allowed to participate in adult trials. To force companies to investigate them separately turns them into paediatric hostages, to adapt the term therapeutic orphans coined in 1968 by Shirkey. There are now five melanoma Paediatric Investigation Plans (PIPs). Probably none of the PIP-triggered clinical studies will ever be completed; we propose to call them ghost studies. An oncology research network considering a reasonable trial in melanoma, including adolescents, will compete for recruitment with the PIP-triggered trials designed by regulatory tunnel vision and sponsored by companies under EMA-imposed pressure. EMA/Paediatric Committee's territorial enthusiasm ("our patients") damages oncology research. Copyright © 2014 John Wiley & Sons, Ltd.

The European Space Agency's FESTIP initiative

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Burleson, Daphne

1998-01-01

In an effort to reduce the cost of access and open up new markets, the European Space Agency has begun a program called Future European Space Transportation Investigations Programme or FESTIP, in which reusable launcher concepts are being studied and developed. The ideal reusable launcher would be comparable to a normal aircraft in that it would be capable of taking off from many possible locations on Earth, enter the desired orbital plane, then accelerate to orbital velocity, release its payload, de-orbit, disperse its kinetic energy and land at the take-off base to be prepared for its next flight following a quick turnaround time. This ideal vehicle would be called the `single-stage-to-orbit reusable rocket launcher' or SSTO-RRL. All space launchers currently in use are staged to orbit and expendable, except the US Space Shuttle, and there is no SSTO-RRL in operation as yet. This paper will discuss the design options being studied by the European Space Agency (ESA) as well as their practical use in serving the space-launch market (FESTIP Workshop 1).

The use of community herbal monographs to facilitate registrations and authorisations of herbal medicinal products in the European Union 2004-2012.

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Peschel, Wieland

2014-12-02

The provisions for the simplified registration of traditional herbal medicinal products in the European Union were introduced by Directive 2004/24/EC amending Directive 2001/83/EC (Chapter 2a) in 2004. Since implementation in the European member states until December 2012 a total of 1015 registrations (traditional use) and 514 authorisations (well-established use) have been granted for products containing substances/ preparations from about 200 different herbal drugs. The overall number of received applications with more than one third still under assessment suggests a further increase for the next years. This review summarises the main features of registered and authorised herbal medicinal products in the EU and evaluates available data against provisions of Directive 2004/24/EC and European standards established by the Committee on Herbal Medicinal Products at the European Medicines Agency. The supportive function of Community herbal monographs is described as regards availability and their use in national procedures, which is complemented by an analysis of specific future challenges from experiences made with the implementation of Directive 2004/24/EC so far. Copyright © 2014. Published by Elsevier Ireland Ltd.

European symposium on precision medicine in allergy and airways diseases

DEFF Research Database (Denmark)

Muraro, A; Fokkens, W J; Pietikainen, S

2015-01-01

suffering from allergies and asthma, more than half of these patients are deprived from adequate diagnosis and treatment. Precision Medicine represents a novel approach in medicine, embracing 4 key features: personalized care based on molecular, immunologic and functional endotyping of the disease......On 14 October 2015, the European Academy of Allergy and Clinical Immunology (EAACI), the European Rhinologic Society (ERS) and the European Medical Association (EMA) organized a symposium in the European Parliament in Brussels on Precision Medicine in Allergy and Airways Diseases, hosted by MEP......, with participation of the patient in the decision making process of therapeutic actions, and taking into account predictive and preventive aspects of the treatment. Implementation of Precision Medicine into clinical practice may help to achieve the arrest of the Epidemic of Allergies and Chronic Airways Diseases...

Contact dermatitis as an adverse reaction to some topically used European herbal medicinal products - part 2: Echinacea purpurea-Lavandula angustifolia.

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Gangemi, Sebastiano; Minciullo, Paola L; Miroddi, Marco; Chinou, Ioanna; Calapai, Gioacchino; Schmidt, Richard J

2015-04-01

This review focuses on contact dermatitis as an adverse effect of a selection of topically used herbal medicinal products for which the European Medicines Agency has completed an evaluation up to the end of November 2013 and for which a Community herbal monograph has been produced. Part 2: Echinacea purpurea Moench-Lavandula angustifolia Mill. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Regulation of Medicines in Croatia - a Contribution to Public Health

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Ilić Martinac, A

2010-07-01

Full Text Available The regulatory system for medicinal products includes the existence of a legislative framework and a medicines agency as the regulatory body. The legislative framework for medicinal products has been amended several times so as to align it with the EU acquis communautaire, where medicinal products represent one of the best regulated and aligned areas. For the purpose of regulating the Croatian medicines market, the Agency for Medicinal Products and Medical Devices was established in 2003 to implement the procedure of granting marketing authorisation for medicinal products, to supervise the adverse reactions of medicinal products, to conduct laboratory tests of the quality of medicines and vaccines sampled from the market, to issue licences for the manufacture and distribution of medicinal products, to monitor medicine consumption, and to inform about medicines and promote their rational use. Medical devices are regulated under a special act, and the Agency conducts entries into the register in that field and carries out vigilance over medical devices. In this way, products intended for health care on the Croatian market are of the appropriate quality, safety and efficacy, and are under the constant supervision of the competent body that assesses their risk-to-benefit ratio. Upon accession of the Republic of Croatia to full membership in the European Union, the Agency will be included in the European authorisation procedures for medicines, such as the centralised procedure in the European Medicines Agency (EMA, and above all, the mutual recognition procedure and decentralised procedure in which the role of the agencies of EU Member States is greater. This article gives an overview of the most important regulatory activities in the field of medicinal products, and the readiness of the Agency to function in the future integrated European regulatory area.

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer.

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Stanel, Stefan Cristian; Sjöberg, Jan; Salmonson, Tomas; Foggi, Paolo; Caleno, Mariapaola; Melchiorri, Daniela; Gravanis, Iordanis; Tzogani, Kyriaki; Pignatti, Francesco

2017-01-01

On 1 February 2013, a marketing authorisation valid throughout the European Union was issued for aflibercept (Zaltrap) in combination with irinotecan/5-fluorouracil/folinic acid chemotherapy for the treatment of adults with metastatic colorectal cancer resistant to or progressive after an oxaliplatin-containing regimen. Aflibercept is a recombinant fusion protein which blocks the activation of vascular endothelial growth factor (VEGF) receptors and the proliferation of endothelial cells, acting as a soluble decoy receptor that binds to VEGF-A with higher affinity than its native receptors, as well as placental growth factor and VEGF-B. The use of aflibercept was studied in a randomised, double-blind, placebo-controlled phase III study, in patients with metastatic colorectal cancer (mCRC) who had previously been treated with an oxaliplatin-based treatment with or without prior bevacizumab. Aflibercept (n=612) was compared with placebo (n=614), both in combination with FOLFIRI (infusional fluorouracil, leucovorin and irinotecan). The primary endpoint of the study was overall survival (OS). The median OS in the intent-to-treat population was 13.5 months in subjects treated with aflibercept compared with 12.1 months for subjects in the control arm (stratified HR=0.817, 95% CI 0.714 to 0.935, stratified pvalue=0.0032). The frequency of adverse events was higher in the aflibercept arm compared with the placebo arm, reflecting the toxicity profile of anti-VEGF agents in combination with chemotherapy. This paper is based on the scientific review of the application leading to approval of aflibercept in the EU. The detailed scientific assessment report and product information for this product are available on the European Medicines Agency website (http://www.ema.europa.eu). Trial registration number NCT00561470, Results.

European Symposium on Precision Medicine in Allergy and Airways Diseases

DEFF Research Database (Denmark)

Muraro, A; Fokkens, W J; Pietikainen, S

2016-01-01

: personalized care based on molecular, immunologic and functional endotyping of the disease, with participation of the patient in the decision making process of therapeutic actions, and considering predictive and preventive aspects of the treatment. Implementation of Precision Medicine into clinical practice......The European Academy of Allergy and Clinical Immunology (EAACI), the European Rhinologic Society (ERS) and the European Medical Association (EMA) organized, on 14 October 2015, a symposium in the European Parliament in Brussels on Precision Medicine in Allergy and Airways Diseases, hosted by MEP...... the most frequently diagnosed chronic non-communicable diseases in the EU. 30% of the total European population is suffering from allergies and asthma, and more than half are deprived from adequate diagnosis and treatment. Precision Medicine represents a novel approach, embracing 4 key features...

Analysis of Medicine Prices in New Zealand and 16 European Countries.

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Vogler, Sabine; Kilpatrick, Kate; Babar, Zaheer-Ud-Din

2015-06-01

To compare prices of medicines, both originators and generics, in New Zealand and 16 European countries. Ex-factory price data as of December 2012 from New Zealand and 16 European countries were compared for a basket of 14 medicines, most of which were at least partially funded by the state in the 17 countries. Five medicines had, at least in some countries, generic versions on the market whose prices were also analyzed. Medicine price data for the 16 European countries were provided by the Pharma Price Information service. New Zealand medicine prices were retrieved from the New Zealand Pharmaceutical Schedule. Unit prices converted into euro were compared at the ex-factory price level. For the 14 medicines surveyed, considerable price differences at the ex-factory price level were identified. Within the European countries, prices in Greece, Portugal, the United Kingdom, and Spain ranked at the lower end, whereas prices in Switzerland, Germany, Denmark, and Sweden were at the upper end. The results for New Zealand compared with Europe were variable. New Zealand prices were found in the lowest quartile for five medicines and in the highest quartile for seven other products. Price differences between the originator products and generic versions ranged from 0% to 90% depending on the medicine and the country. Medicine prices varied considerably between European countries and New Zealand as well as among the European countries. These differences are likely to result from national pricing and reimbursement policies. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Contact dermatitis as an adverse reaction to some topically used European herbal medicinal products - Part 3: Mentha × piperita - Solanum dulcamara.

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Calapai, Gioacchino; Minciullo, Paola L; Miroddi, Marco; Chinou, Ioanna; Gangemi, Sebastiano; Schmidt, Richard J

2016-03-01

This review focuses on contact dermatitis as an adverse effect of a selection of topically used herbal medicinal products for which the European Medicines Agency has completed an evaluation up to the end of November 2013 and for which a Community herbal monograph - now (since 2015)(†) called a European Union herbal monograph - has been produced. Part 3: Mentha × piperita L.-Solanum dulcamara L. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Contact dermatitis as an adverse reaction to some topically used European herbal medicinal products - part 1: Achillea millefolium-Curcuma longa.

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Calapai, Gioacchino; Miroddi, Marco; Minciullo, Paola L; Caputi, Achille P; Gangemi, Sebastiano; Schmidt, Richard J

2014-07-01

This review focuses on contact dermatitis as an adverse effect of a selection of topically used herbal medicinal products for which the European Medicines Agency has completed an evaluation up to the end of November 2013 and for which a Community herbal monograph has been produced. Part 1: Achillea millefolium L.-Curcuma longa L. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Non-European traditional herbal medicines in Europe: a community herbal monograph perspective.

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Qu, Liping; Zou, Wenjun; Zhou, Zhenxiang; Zhang, Tingmo; Greef, JanVander; Wang, Mei

2014-10-28

The European Directive 2004/24/EC introducing a simplified registration procedure for traditional herbal medicinal products, plays an important role in harmonising the current legislation framework for all herbal medicinal products in the European Union (EU). Although substantial achievements have been made under the new scheme, only a limited number of herbal medicinal products from non-European traditions commonly used in Europe have been registered. Therefore, identification of the obstacles, and determination of appropriate means to overcome the major challenges in the registration of non-European traditional herbal medicinal products are of critical importance for the EU herbal medicinal product market. The primary aims of this study were to understand the key issues and obstacles to registration of non-European traditional herbal medicinal products within the EU. The findings may identify the need for more attention on the Community herbal monographs elaborated by the Herbal Medicinal Products Committee (HMPC), as well as further evidence based scientific research on non-European herbal substances/preparations by the scientific community. A systematic evaluation of the herbal substances and preparations included in Community herbal monographs and public statements has been carried out. The focus was herbal substances and preparations derived from non-European traditions. Of the 109 adopted Community herbal monographs, 10 are herbal substances used in Chinese traditional medicine. Where the HMPC issued a public statement because it was unable to elaborate a monograph more than half-involved herbal substances/preparations from non-European traditions. The main reasons herbal substances/preparations from non-European traditions were not accepted for inclusion in the Community herbal monographs have been identified as due to unfulfilled requirements of Directive 2004/24/EC. The most common reasons were the lack of evidence to demonstrate a 15-year minimum

A European network for nuclear medicine and radiotherapy. EMIR

International Nuclear Information System (INIS)

Jehenson, P.; Lartigau, E.; Guidez, J.

2003-01-01

Nuclear medicine and radiotherapy make a vital contribution to the diagnosis and treatment of major disease. This role is likely to expand with new developments including availability of new medical isotopes. A European network (EMIR) was initiated in 2001 by the Joint Research Centre (JRC) of the European Commission, to identify and solve difficulties that constrain nuclear medicine and radiotherapy development in Europe and facilitate closer interdisciplinary collaboration. Participating organisations include the main European associations of medical radiation specialists, radiopharmaceutical/radioisotope producers, nuclear research reactor institutions, research organizations and the JRC. The steering committee established task groups focusing on eight key areas for development. Liaison with non-European organizations will be encouraged. (author)

The European physical and rehabilitation medicine journal network: historical notes on national journals.

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Negrini, S; Ilieva, E; Moslavac, S; Zampolini, M; Giustini, A

2010-06-01

In the last 40 years, physical and rehabilitation medicine (PRM) has made significant steps forward in Europe with the foundation of the European Federation of Physical Medicine and Rehabilitation (EFPMR) (1963) which gave rise to the European Society of Physical and Rehabilitation Medicine (ESPRM) (2004) the European Academy of Rehabilitation Medicine (1970), the PRM Section of the European Union of Medical Specialists (1974), and the European Board of PRM (1991). Our journal, formerly Europa Medico-physica (1964), the official journal of the EFPMR, now European Journal of Physical and Rehabilitation Medicine (EJPRM) and official journal of the ESPRM since 2008, is distinct for its steadfast European vocation, long-standing Mediter-ranean interests and connections with various national scientific societies. Jointly with the ESPRM, efforts are under way to set up the European Physical and Rehabilitation Medicine Journal Network (EPRMJN). The aim of this article is to present a profile of the national journals in the EPRMJN so as to give a better overview of how the scientific part of PRM in Europe has developed within a national perspective. A profile of the following national journals is presented: Annals of Physical and Rehabilitation Medicine (France), Fizikalna i rehabilitacijska medicina (Physical and Rehabilitation Medicine) (Croatia), Neurorehabilitation (Bulgaria), Physical and Rehabilitation Medicine Portuguese Society Journal (Portugal), Physical Medicine, Rehabilitaton, Health (Bulgaria), Physikalische Medizin - Rehabilitationsmedizin - Kurort-medizin/Journal of Physical and Rehabilitation Medicine (Germany and Austria) Prevention and Rehabilitation (Bulgaria), Rehabilitacija (Rehabilitation) (Slovenia), Rehabilitación (Madr) (Spain), Turkish Journal of Physical Medicine and Rehabilitation (Turkey). Some national journals in Europe have a very long history and tradition of research and education. Having a better knowledge of these realities, usually

Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union.

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Vlietinck, Arnold; Pieters, Luc; Apers, Sandra

2009-06-01

In the European Union (EU) herbal medicinal products have become increasingly important. This is, for instance, underlined by the recent introduction of a simplified procedure in the Member States of the EU allowing the registration of herbal medicinal products which fulfill the criteria of a traditional herbal medicinal product, i.e., sufficient evidence of its medicinal use throughout a period of at least 30 years for products in the EU and at least 15 years within the EU and 15 years elsewhere for products outside the EU. With regard to the manufacturing of these products and their quality, applications of traditional herbal medicinal products have to fulfil the same requirements as applications for a marketing authorization. The quality of herbal substances as well as herbal preparations will be determined by the availability of modern science-based public monographs in the European Pharmacopoeia and their equivalents developed by the pharmaceutical industry. The standards put forward in these monographs must allow us not only to define the quality of these products, but also to eliminate dangerous counterfeit, substandard, adulterated and contaminated (traditional) herbal medicinal products. The usefulness of these monographs to implement the criteria on quality and specifications put forward for these products in the different guidelines of the European Medicines Agency (EMEA) is discussed.

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency

DEFF Research Database (Denmark)

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis

2017-01-01

OBJECTIVE: To characterize and quantify barriers towards the publication of academic drug trials. STUDY DESIGN: We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates...... of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines...... agencies since 2004. RESULTS: A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were...

The European Medicines Agency Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma.

Science.gov (United States)

Tzogani, Kyriaki; van Hennik, Paula; Walsh, Ita; De Graeff, Pieter; Folin, Annika; Sjöberg, Jan; Salmonson, Tomas; Bergh, Jonas; Laane, Edward; Ludwig, Heinz; Gisselbrecht, Christian; Pignatti, Francesco

2017-11-30

.9%), neutropenia (16.5%) and lymphopenia (8.1%).This article summarizes the scientific review of the application leading to regulatory approval in the European Union. The full scientific assessment report and product information, including the Summary of Product Characteristics, are available on the European Medicines Agency website (http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landing_page.jsp&mid=). Farydak was approved in the European Union in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent (IMiD). The addition of panobinostat to bortezomib and dexamethasone resulted in a clinically meaningful and statistically significant improvement of progression-free survival compared with bortezomib and dexamethasone, and an additional therapeutic option with a new mechanism of action was considered valuable. Although the toxicity associated with panobinostat combination was significant, at the time of the marketing authorization of panobinostat, it was considered that it was acceptable and that it should be left to the clinician and the patient to decide whether the panobinostat combination is the preferred treatment option or not. © AlphaMed Press 2017.

Veterinary medicinal products for the bees - the current situation and future strategies - an important topic discussed at European level

Directory of Open Access Journals (Sweden)

Alina Karina Draghici,

2010-12-01

Full Text Available To analyze the current situation and future issues relating to health and treatment options bees, bee breeders in Europe, agencies and drug manufacturers in Europe have held several meetings. One of thesetook place last year in December at the EMEA (European Medicines Agency in London, United Kingdom. The purpose of this meeting was to consider the current situation of pathology in bees to identify the most common diseases found in this species, identification and lack of treatment options for some diseases, and identifying solutions to improve the situation.

The Brazilian medicinal chemistry from 1998 to 2008 in the Journal of Medicinal Chemistry, Bioorganic and Medicinal Chemistry, Bioorganic and Medicinal Chemistry Letters and European Journal of Medicinal Chemistry [A química medicinal brasileira de 1998 a 2008 nos periódicos Journal of Medicinal Chemistry, Bioorganic and Medicinal Chemistry, Bioorganic and Medicinal Chemistry Letters e European Journal of Medicinal Chemistry

OpenAIRE

Bárbara Vasconcellos da Silva; Renato Saldanha Bastos; Angelo da Cunha Pinto

2009-01-01

In this article we present the Brazilian publications, the research groups involved, the contributions per states and the main diseases studied from 1998 to 2008 in the following periodicals: Journal of Medicinal Chemistry, Bioorganic and Medicinal Chemistry, Bioorganic and Medicinal Chemistry Letters and European Journal of Medicinal Chemistry.

Registries in European post-marketing surveillance

DEFF Research Database (Denmark)

Bouvy, Jacoline C; Blake, Kevin; Slattery, Jim

2017-01-01

at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. METHODS: European Public Assessment Reports were consulted to identify products for which a request...

European regulation model for herbal medicine: The assessment of the EU monograph and the safety and efficacy evaluation in marketing authorization or registration in Member States.

Science.gov (United States)

Qu, Liping; Zou, Wenjun; Wang, YiTao; Wang, Mei

2018-03-15

The European Union (EU) has created a regulatory framework for herbal medicinal products (HMPs) since the enforcement of Directive 2004/24/EC. Substantial achievements have been made, with 1719 traditional use marketing registrations (TURs) and 859 well-established use marketing authorizations (WEU-MAs) for HMPs granted by the end of 2016. Apparently, the European regulation model has worked out well and in that the essential feature is the use of EU herbal monographs into those granted WEU-MAs and TURs. A systematic analysis of the European regulation model for HMPs and the EU herbal monograph's part of this model are undertaken to assist understanding of the EU legislation particularly for interested parties those from outside EU area, and afterwards, to help in decision-making in the HMPs registration in European market for pharmaceutical companies, as well as in the establishment of legislation in countries with strong traditional use of herbal remedies. A search of PubMed, ScienceDirect, the European Medicines Agency website and the Heads of Medicines Agencies website was conducted (up to December 2017), and the available information on regulation of HMPs in the EU was collected. The evaluation of applications by National Competent Authorities (NCAs) at a national level together with the assessment of EU monographs by the Committee on Herbal Medicinal Products (HMPC) at the European level constitute the European regulation framework for HMPs. As the scientific opinion about the safety and efficacy of HMPs from HMPC, the EU herbal monographs have been given a constitutional-based meaning to the TURs and WEU-MAs of HMPs and play a supportive function in the marketing procedure in Member States. The European framework has provided a powerful regulation model for harmonization of scientific assessment and facilitation of product marketing. For the pharmaceutical industries particularly those outside the EU, optimal use of the EU herbal monograph in their marketing

Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database

DEFF Research Database (Denmark)

Jakobsen, Klaus D.; Wallach-Kildemoes, Helle; Bruhn, Christina H.

2017-01-01

Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children...... and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported......, hallucinations. As some of the reported ADEs are life threatening and not listed as ADRs in the SPCs, off-label use of quetiapine in children and adolescents gives rise to safety concerns....

Laboratory medicine in the European Union.

Science.gov (United States)

Oosterhuis, Wytze P; Zerah, Simone

2015-01-01

The profession of laboratory medicine differs between countries within the European Union (EU) in many respects. The objective of professional organizations of the promotion of mutual recognition of specialists within the EU is closely related to the free movement of people. This policy translates to equivalence of standards and harmonization of the training curriculum. The aim of the present study is the description of the organization and practice of laboratory medicine within the countries that constitute the EU. A questionnaire covering many aspects of the profession was sent to delegates of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and Union Européenne de Médecins Spécialistes (UEMS) of the 28 EU countries. Results were sent to the delegates for confirmation. Many differences between countries were identified: predominantly medical or scientific professionals; a broad or limited professional field of interest; inclusion of patient treatment; formal or absent recognition; a regulated or absent formal training program; general or minor application of a quality system based on ISO Norms. The harmonization of the postgraduate training of both clinical chemists and of laboratory physicians has been a goal for many years. Differences in the organization of the laboratory professions still exist in the respective countries which all have a long historical development with their own rationality. It is an important challenge to harmonize our profession, and difficult choices will need to be made. Recent developments with respect to the directive on Recognition of Professional Qualifications call for new initiatives to harmonize laboratory medicine both across national borders, and across the borders of scientific and medical professions.

Intergovernmental organisation activities: European Atomic Energy Community, International Atomic Energy Agency, OECD Nuclear Energy Agency

International Nuclear Information System (INIS)

Anon.

2012-01-01

European Atomic Energy Community: Proposed legislative instruments, Adopted legislative instruments, Non-legislative instruments, Other activities (meetings). International Atomic Energy Agency: IAEA Action Plan on Nuclear Safety. OECD Nuclear Energy Agency: The Russian Federation to join the OECD Nuclear Energy Agency; Participation by the regulatory authorities of India and the United Arab Emirates in the Multinational Design Evaluation Programme (MDEP); NEA International Workshop on Crisis Communication, 9-10 May 2012; International School of Nuclear Law: 2013; Next NEA International Nuclear Law Essentials Course

Current Status and Future Perspective in the Globalization of Traditional Chinese Medicines

OpenAIRE

Wan-Ying Wu; Wen-Zhi Yang; Jin-Jun Hou; De-An Guo

2015-01-01

Globalization of traditional Chinese medicines started around 1996, which was initiated by the Chinese government. However, substantial progress was only achieved in recent years including the adoption of TCM quality monographs in the western pharmacopoeias (United States Pharmacopoeia and European Pharmacopoeia) and registration in main stream drug regulatory agencies such as US Food and Drug Administration (FDA) and European Medicines Agency (EMA). So far, several TCM herbal quality monogra...

European responses to the Ebola crisis- Part I: Initiatives at the European Medicines Agency (EMA)

DEFF Research Database (Denmark)

Minssen, Timo

2014-01-01

to potential new medicines to counter Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new...

Affordability of medicines in the European Union.

Directory of Open Access Journals (Sweden)

Tomasz Zaprutko

Full Text Available Medications and their prices are key issues for healthcare. Although access to medicines at affordable prices had been specified as a key objective of the European Health Policy, it seems that these goals have not been achieved. Therefore, we attempted an evaluation of affordability of selected medicines at full prices.The analysis concerned 2012 and was conducted between 2013 and 2015 in all the European Union (EU countries divided into 3 groups depending on the date of their accession to the EU. Finally, we considered 9 originators used in the treatment of schizophrenia and multiple sclerosis. Information on drug prices were collected from pharmacies. Participation in the study was voluntary and anonymous in order to avoid accusations of advertising. To evaluate affordability, several factors were used (e.g. minimum earnings and Gini coefficient. Due to unavailability in some countries, the exact number of analyzed medicines varies.Drug prices vary significantly between EU Member States. Almost eleven fold difference was observed between Germany (EUR 1451.17 and Croatia (EUR 132.77 in relation to Interferone beta-1a 22 μg. Generally, prices were the highest in Germany. The cheapest drugs were found in various countries but never in the poorest ones like Bulgaria or Romania. Discrepancies in wages were observed too (the smallest minimum wage was EUR 138.00 in Bulgaria and the highest EUR 1801.00 in Luxembourg. Full price of olanzapine 5mg, however, was higher in Bulgaria (EUR 64.53 than, for instance, in Belgium (EUR 37.26.Analyzed medications are still unaffordable for many citizens of the EU. Besides, access to medicines is also impaired e.g. due to parallel trade. Unaffordability of medications may lead to the patients' non-compliance and therefore to increased direct and indirect costs of treatment. Common European solutions are needed to achieve a real affordability and accessibility of medications.

Medieval European medicine and Asian spices.

Science.gov (United States)

Nam, Jong Kuk

2014-08-01

This article aimed to explain the reasons why Asian spices including pepper, ginger, and cinnamon were considered as special and valuable drugs with curative powers in the Medieval Europe. Among these spices, pepper was most widely and frequently used as medicine according to medieval medical textbooks. We analyzed three main pharmacology books written during the Middle Ages. One of the main reasons that oriental spices were widely used as medicine was due to the particular medieval medical system fundamentally based on the humoral theory invented by Hippocrates and Galen. This theory was modified by Arab physicians and imported to Europe during the Middle Ages. According to this theory, health is determined by the balance of the following four humors which compose the human body: blood, yellow bile, black bile, and phlegm. Each humor has its own qualities such as cold, hot, wet, and dry. Humoral imbalance was one of the main causes of disease, so it was important to have humoral equilibrium. Asian spices with hot and dry qualities were used to balance the cold and wet European diet. The analysis of several major medical textbooks of the Middle Ages proves that most of the oriental spices with hot and dry qualities were employed to cure diverse diseases, particularly those caused by coldness and humidity. However, it should be noted that the oriental spices were considered to be much more valuable and effective as medicines than the local medicinal ingredients, which were not only easily procured but also were relatively cheap. Europeans mystified oriental spices, with the belief that they have marvelous and mysterious healing powers. Such mystification was related to the terrestrial Paradise. They believed that the oriental spices were grown in Paradise which was located in the Far East and were brought to the Earthly world along the four rivers flowing from the Paradise.

[The Working Group of Enforcement Officers (WGEO) : The European Network of Drug Regulatory Authorities to Combat Pharmaceutical Crime].

Science.gov (United States)

Wittstock, Marcus; Streit, Renz

2017-11-01

Ten years ago the Heads of Medicines Agencies (HMA) officially founded the Working Group of Enforcement Officers (WGEO), a European working group to reduce falsifications of human and veterinarian medicinal products in the legal and illegal supply chain. Police, customs and other international organisations are also represented in the WGEO. Partner organisations are for example the Directorate General for Health and Food Safety of the European Commission, the European Medicines Agency (EMA), the European Police Office (Europol), the International Criminal Police Organization (Interpol), the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the World Health Organization (WHO). The main goal of the group is the protection of public health from harmful medicines for both humans and animals. The WGEO has created a network of its members and a rapid alert system to exchange confidential information on falsified or stolen medicinal products. There are face-to-face meetings twice a year including training using case studies.

Quality evaluation of medicinal products and health foods containing chaste berry (Vitex agnus-castus) in Japanese, European and American markets.

Science.gov (United States)

Fukahori, Masahiro; Kobayashi, Shojiro; Naraki, Yoko; Sasaki, Takahiro; Oka, Hideki; Seki, Masaharu; Masada-Atsumi, Sayaka; Hakamatsuka, Takashi; Goda, Yukihiro

2014-01-01

The aim of present study was to evaluate the qualities of chaste berry (fruit of Vitex agnus-castus L.) preparations using HPLC fingerprint analysis. Seven medicinal products 1 from Japan and 6 from Europe, and 17 health foods, 6 from Japan and 11 from the United States were analyzed. HPLC profile and 26 authentic peaks were compared medicinal products and health foods. Whereas medicinal products had similar HPLC profiles, health foods had various profiles and each peak was also greatly different. The measured amounts of two markers in 5 traditional medicinal products, agnuside and casticin specified in the European Pharmacopoeia (EP), the U.S. Pharmacopoeia (USP) or the WHO monographs of chaste berry, were much lower than those in 2 medicinal products defined as "well-established use" by the European Medicines Agency. The amounts of two markers for 17 health foods differed in a great deal from 14-5054% and 3-1272%, respectively. Furthermore the amount ratios of two markers, agnuside/casticin, in about half of the health foods were remarkably larger than the standard crude drug and the ratios were closer to one of the related Chinese herbs, Vitex negundo L. It is concluded that a combination of HPLC fingerprints and the amount ratios of the marker compounds of chaste berry preparations serves as a useful tool to evaluate the qualities of these preparations.

European Symposium on Precision Medicine in Allergy and Airways Diseases: Report of the European Union Parliament Symposium (October 14, 2015)

NARCIS (Netherlands)

Muraro, A.; Fokkens, W. J.; Pietikainen, S.; Borrelli, D.; Agache, I.; Bousquet, J.; Costigliola, V.; Joos, G.; Lund, V. J.; Poulsen, L. K.; Price, D.; Rolland, C.; Zuberbier, T.; Hellings, P. W.

2016-01-01

The European Academy of Allergy and Clinical Immunology (EAACI), the European Rhinologic Society (ERS), and the European Medical Association (EMA) organized, on October 14, 2015, a symposium in the European Parliament in Brussels on Precision Medicine in Allergy and Airways Diseases, hosted by MEP

Lythrum salicaria L.-Underestimated medicinal plant from European traditional medicine. A review.

Science.gov (United States)

Piwowarski, Jakub P; Granica, Sebastian; Kiss, Anna K

2015-07-21

Purple loosestrife-Lythrum salicaria L. is a herbaceous perennial plant belonging to the Lythraceae family. It has been used for centuries in European traditional medicine. Despite Lythri herba being a pharmacopoeial plant material (Ph. Eur.), L. salicaria popularity as a medicinal plant has recently declined. The aim of the paper is to recall a traditional and historical use of L. salicaria and juxtapose it with comprehensive view on the current knowledge about its chemical composition and documented biological activities in order to bring back the interest into this valuable plant and indicate reasonable directions of future research and possible applications. Systematic survey of historical and ethnopharmacological literature was carried out using sources of European and American libraries. Pharmacological and phytochemical literature research was performed using Scopus, PubMed, Web of Science and Reaxys databases. The review of historical sources from ancient times till 20th century revealed an outstanding position of L. salicaria in traditional medicine. The main applications indicated were gastrointestinal tract ailments (mainly dysentery and diarrhea) as well as different skin and mucosa affections. The current phytochemical studies have shown that polyphenols (C-glucosidic ellagitannins and C-glucosidic flavonoids) as well as heteropolysaccharides are dominating constituents, which probably determine the observed pharmacological effects. The extracts and some isolated compounds were shown to possess antidiarrheal, antimicrobial, anti-oxidant, anti-inflammatory and anti-diabetic activities. The intrinsic literature overview conclusively demonstrates that L. salicaria L. used to be considered as an exceptionally effective remedy in European traditional medicine. Despite its unquestionable important position from unknown reasons its popularity has been weakened during the past few decades. Unfortunately the contemporary pharmacological research is still

Meeting staff representatives of the European Agencies

CERN Multimedia

Staff Association

2014-01-01

  The AASC (Assembly of Agency Staff Committee) held its 27th Meeting of the specialized European Agencies on 26 and 27 May on the premises of the OHIM (Office for Harmonization in the Internal Market) in Alicante, Spain. Two representatives of the CERN Staff Association, in charge of External Relations, attended as observers. This participation is a useful complement to regular contacts we have with FICSA (Federation of International Civil Servants' Associations), which groups staff associations of the UN Agencies, and the annual CSAIO conferences (Conference of Staff Associations of International Organizations), where each Autumn representatives of international organizations based in Europe meet to discuss themes of common interest to better promote and defend the rights of the international civil servants. All these meetings allow us to remain informed on items that are directly or indirectly related to employment and social conditions of our colleagues in other international and Europ...

Review: UK medicines likely to be affected by the proposed European Medicines Agency's guidelines on phthalates.

Science.gov (United States)

Jamieson, Lisa; McCully, William

2015-06-13

Phthalates are excipients in drug formulations. However, concerns have been raised about the effects of particular phthalates on reproduction and development. As a result the EMA has introduced guidelines for permitted daily exposure (PDE) limits for certain phthalates. Therefore, the objective of this study was to identify UK licensed medicines that contain the relevant phthalates and determine if they fall within the recommended PDE. The eMC was used to identify which UK licensed medicines contain the phthalates in question. Companies were then contacted for information on the phthalate levels in their products, which was compared with the PDE recommended by the EMA. The eMC search revealed that 54 medicines contained at least one of the phthalates in question. However, only six medicines, namely Asacol 800 mg MR (Warner Chilcott UK), Epilim 200 Gastro-resistant tablets (Sanofi), Prednisolone 2.5 mg and 5 mg Gastro-resistant tablets (Actavis UK), Vivotif (Crucell Italy S.r.l), and Zentiva 200 mg Gastro-resistant tablets (Winthrop Pharmaceuticals UK), were identified as containing levels that exceeded the recommended PDE. These findings indicate that very few UK licensed medicines will be affected by the proposed EMA guidelines. For those medicines identified as exceeding recommendations, these findings highlight the need to instigate a risk-benefit review.

Early Patient Access to Medicines: Health Technology Assessment Bodies Need to Catch Up with New Marketing Authorization Methods.

Science.gov (United States)

Leyens, Lada; Brand, Angela

National and international medicines agencies have developed innovative methods to expedite promising new medicines to the market and facilitate early patient access. Some of these approval pathways are the conditional approval and the adaptive pathways by the European Medicines Agency (EMA); the Promising Innovative Medicine (PIM) designation and the Early Access to Medicines Scheme (EAMS) by the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as the Fast Track, Breakthrough or Accelerated Approval methods by the Food and Drug Administration (FDA). However, at least in Europe, these methods cannot achieve the goal of improving timely access for patients to new medicines on their own; the reimbursement process also has to become adaptive and flexible. In the past 2 years, the effective access (national patient access) to newly approved oncology drugs ranged from 1 to 30 months, with an extremely high variability between European countries. The goal of early patient access in Europe can only be achieved if the national health technology assessment bodies, such as NICE (ENG), HAS (FR), G-BA (DE) or AIFA (IT), provide harmonized, transparent, flexible, conditional and adaptive methods that adopt the level of evidence accepted by the medicines agencies. The efforts from medicines agencies are welcome but will be in vain if health technology assessments do not follow with similar initiatives, and the European 'postcode' lottery will continue. © 2016 S. Karger AG, Basel.

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: guide to the Register, version 3-2010

DEFF Research Database (Denmark)

McMurray, Janet; Zérah, Simone; Hallworth, Michael

2010-01-01

In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 12 years, more...... than 2200 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Two previous...

The Impact of the European Standards and Guidelines in Agency Evaluations

Science.gov (United States)

Stensaker, Bjorn; Harvey, Lee; Huisman, Jeroen; Langfeldt, Liv; Westerheijden, Don F.

2010-01-01

The emergence of the European Standards and Guidelines (ESG) for Quality Assurance has been seen as an important step towards realising the European Higher Education Area by creating more transparency and accountability in the area of quality assurance. The ESG also include standards as to how quality assurance agencies should be reviewed. In a…

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

Science.gov (United States)

Kroes, Burt H

2014-12-02

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply

Patient Access to Medicines for Rare Diseases in European Countries.

Science.gov (United States)

Detiček, Andreja; Locatelli, Igor; Kos, Mitja

2018-05-01

The number of authorized orphan and non-orphan medicines for rare diseases has increased in Europe. Patient access to these medicines is affected by high costs, weak efficacy/safety evidence, and societal value. European health care systems must determine whether paying for expensive treatments for only a few patients is sustainable. This study aimed to evaluate patient access to orphan and non-orphan medicines for rare diseases in 22 European countries during 2005 to 2014. Medicines for rare diseases from the Orphanet list, authorized during 2005 to 2014, were searched for in the IMS MIDAS Quarterly Sales Data, January 2005 - December 2014 (IQVIA, Danbury, CT). The following three measures were determined for each country: number of available medicines, median time to continuous use, and medicine expenditure. A medicine was considered available if uninterrupted sales within a 1-year period were detected. From 2005 to 2014, 125 medicines were authorized and 112 were found in the search. Of those, between 70 (63%) and 102 (91%) were available in Germany, the United Kingdom, Italy, France, and the Scandinavian countries. These countries were also the fastest to enable continuous use (3-9 mo). Only 27% to 38% of authorized medicines were available in Greece, Ireland, Bulgaria, Romania, and Croatia, which took 1 to 2.6 years to begin continuous use. A country's expenditure on medicines for rare diseases in 2014 ranged between €0.2 and €31.9/inhabitant. Patient access to medicines for rare diseases varies largely across Europe. Patients in Germany, Scandinavian countries, Switzerland, France, and the United Kingdom can access larger numbers of medicines in shorter time. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

European Symposium on Precision Medicine in Allergy and Airways Diseases: Report of the European Union Parliament Symposium (October 14, 2015).

Science.gov (United States)

Muraro, A; Fokkens, W J; Pietikainen, S; Borrelli, D; Agache, I; Bousquet, J; Costigliola, V; Joos, G; Lund, V J; Poulsen, L K; Price, D; Rolland, C; Zuberbier, T; Hellings, P W

2016-05-01

The European Academy of Allergy and Clinical Immunology (EAACI), the European Rhinologic Society (ERS), and the European Medical Association (EMA) organized, on October 14, 2015, a symposium in the European Parliament in Brussels on Precision Medicine in Allergy and Airways Diseases, hosted by MEP David Borrelli, and with active participation of the EU Commissioner for Health and Food Safety Vytenis Andriukaitis, MEP Sirpa Pietikainen, Chair of the European Parliament Interest Group on Allergy and Asthma, the European Respiratory Society (ERS), the European Federations of Allergy and Airways Diseases Patients Associations (EFA), the Global Allergy and Asthma European Network (Ga2len), Allergic Rhinitis and Its Impact on Asthma (ARIA), and the Respiratory Effectiveness Group (REG). The socioeconomic impact of allergies and chronic airways diseases cannot be underestimated, as they represent the most frequently diagnosed chronic noncommunicable diseases in the EU; 30% of the total European population is suffering from allergies and asthma, and more than half are deprived from adequate diagnosis and treatment. Precision medicine represents a novel approach, embracing four key features: personalized care based on molecular, immunologic, and functional endotyping of the disease, with participation of the patient in the decision-making process of therapeutic actions, and considering predictive and preventive aspects of the treatment. Implementation of precision medicine into clinical practice may help to achieve the arrest of the epidemic of allergies and chronic airways diseases. Participants underscored the need for optimal patient care in Europe, supporting joint action plans for disease prevention, patient empowerment, and cost-effective treatment strategies. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Current Status and Future Perspective in the Globalization of Traditional Chinese Medicines

Directory of Open Access Journals (Sweden)

Wan-Ying Wu

2015-01-01

Full Text Available Globalization of traditional Chinese medicines started around 1996, which was initiated by the Chinese government. However, substantial progress was only achieved in recent years including the adoption of TCM quality monographs in the western pharmacopoeias (United States Pharmacopoeia and European Pharmacopoeia and registration in main stream drug regulatory agencies such as US Food and Drug Administration (FDA and European Medicines Agency (EMA. So far, several TCM herbal quality monographs were adopted by the United States Pharmacopoeia including Chinese Salvia, Ganoderma lucidum and Panax notoginseng, etc. Over 45 TCM quality monographs were recorded in the European Pharmacopoeia with 20 more in progress. After the successful registration of the first TCM product named Diao Xin Xue Kang as traditional medicine via the Medicines Evaluation Board of the Netherlands, several other TCM herbal products are in the registration process in several European member states. So far, there has been still not any TCM product authorized as a drug by the FDA regardless of a few TCM products in phase III or phase II clinical trials. This review summarizes the progress made in the globalization of traditional Chinese medicines in recent years and future issues in this regard.

The European Space Agency and the European Union: The Next Step on the Road to the Stars

Directory of Open Access Journals (Sweden)

Thomas Christian Hoerber

2009-11-01

Full Text Available Given the outlook, the main questions considered in this article are whether a European position on a genuine common space policy is developing. If so, why is this happening now?; and what kind of potentials do these developments hold for the European integration process as a whole? This article will approach these questions through an analysis of past European collaboration in space affairs. It will describe the recent process of closer involvement between European Space Agency (ESA and the European Union (EU. It will identify the motivations underlying this process. It will also try to gauge the strategic potential of an intensification of the coordination of national space efforts in ESA and the involvement of the EU. In the conclusion, the ever closer relationship between the EU and ESA will be considered against the larger picture of European politics and the ongoing process of European integration

Combatting Falsification and Counterfeiting Of Medicinal Products in the European Union

DEFF Research Database (Denmark)

Kohli, Vishv Priya

and falsification of medicinal products meets the social objectives of public health (Articles 9 and 168) and consumer protection (Articles 12 and 169), as envisaged by the Treaty on the Function of the European Union. The thesis establishes that the problem of counterfeiting and falsification of medicinal products...... lies at the intersection of three spheres of law - IP law, Medicine law, and Criminal law. This insight provides the foundation for the understanding of the weaknesses in the legal regime that contains tools for combatting counterfeiting and falsification of medicines in the EU....

The European Society for Medical Oncology (ESMO) Precision Medicine Glossary.

Science.gov (United States)

Yates, L R; Seoane, J; Le Tourneau, C; Siu, L L; Marais, R; Michiels, S; Soria, J C; Campbell, P; Normanno, N; Scarpa, A; Reis-Filho, J S; Rodon, J; Swanton, C; Andre, F

2018-01-01

Precision medicine is rapidly evolving within the field of oncology and has brought many new concepts and terminologies that are often poorly defined when first introduced, which may subsequently lead to miscommunication within the oncology community. The European Society for Medical Oncology (ESMO) recognises these challenges and is committed to support the adoption of precision medicine in oncology. To add clarity to the language used by oncologists and basic scientists within the context of precision medicine, the ESMO Translational Research and Personalised Medicine Working Group has developed a standardised glossary of relevant terms. Relevant terms for inclusion in the glossary were identified via an ESMO member survey conducted in Autumn 2016, and by the ESMO Translational Research and Personalised Medicine Working Group members. Each term was defined by experts in the field, discussed and, if necessary, modified by the Working Group before reaching consensus approval. A literature search was carried out to determine which of the terms, 'precision medicine' and 'personalised medicine', is most appropriate to describe this field. A total of 43 terms are included in the glossary, grouped into five main themes-(i) mechanisms of decision, (ii) characteristics of molecular alterations, (iii) tumour characteristics, (iv) clinical trials and statistics and (v) new research tools. The glossary classes 'precision medicine' or 'personalised medicine' as technically interchangeable but the term 'precision medicine' is favoured as it more accurately reflects the highly precise nature of new technologies that permit base pair resolution dissection of cancer genomes and is less likely to be misinterpreted. The ESMO Precision Medicine Glossary provides a resource to facilitate consistent communication in this field by clarifying and raising awareness of the language employed in cancer research and oncology practice. The glossary will be a dynamic entity, undergoing

Respiratory medicines for children: current evidence, unlicensed use and research priorities

DEFF Research Database (Denmark)

Smyth, A R; Barbato, A; Beydon, N

2010-01-01

deficiency. We hope that this summary of the evidence for respiratory medicines in children, highlighting gaps and research priorities, will be useful for the pharmaceutical industry, the paediatric committee of the European Medicines Agency, academic investigators and the lay public.......This European Respiratory Society task force has reviewed the evidence for paediatric medicines in respiratory disease occurring in adults and children. We describe off-licence use, research priorities and ongoing studies. Off-licence and off-label prescribing in children is widespread...

Oral medicines for children in the European paediatric investigation plans.

Directory of Open Access Journals (Sweden)

Diana A van Riet-Nales

Full Text Available INTRODUCTION: Pharmaceutical industry is no longer allowed to develop new medicines for use in adults only, as the 2007 Paediatric Regulation requires children to be considered also. The plans for such paediatric development called Paediatric Investigation Plans (PIPs are subject to agreement by the European Medicines Agency (EMA and its Paediatric Committee (PDCO. The aim of this study was to evaluate the key characteristics of oral paediatric medicines in the PIPs and the changes implemented as a result of the EMA/PDCO review. METHODS: All PIPs agreed by 31 December 2011 were identified through a proprietary EMA-database. PIPs were included if they contained an agreed proposal to develop an oral medicine for children 0 to 11 years. Information on the therapeutic area (EMA classification system; target age range (as defined by industry and pharmaceutical characteristics (active substance, dosage form(s as listed in the PIP, strength of each dosage form, excipients in each strength of each dosage form was extracted from the EMA website or the EMA/PDCO assessment reports. RESULTS: A hundred and fifty PIPs were included corresponding to 16 therapeutic areas and 220 oral dosage forms in 431 strengths/compositions. Eighty-two PIPs (37% included tablets, 44 (20% liquids and 35 (16% dosage forms with a specific composition/strength that were stored as a solid but swallowed as a liquid e.g. dispersible tablets. The EMA/PDCO review resulted in an increase of 13 (207 to 220 oral paediatric dosage forms and 44 (387 to 431 dosage forms with a specific composition/strength. For many PIPs, the target age range was widened and the excipient composition and usability aspects modified. CONCLUSION: The EMA/PDCO review realized an increase in the number of requirements for the development of oral dosage forms and a larger increase in the number of dosage forms with a specific composition/strength, both targeting younger children. Changes to their pharmaceutical

New veterinary medicinal products authorised by centralised procedure

Directory of Open Access Journals (Sweden)

Simona Sturzu

2012-06-01

Full Text Available Veterinary medicinal products that are subject to authorization via the centralized procedure according to Regulation (EC no. 726/2004 are included in the Community register of veterinary medicines, that is published on the European Commission website and product information of them are published on the website of the European Medicines Agency. Each competent authority involved in the linguistic review process of product information annexed to the Marketing Authorization for medicinal products authorized centrally (SPC, leaflet, information about the marketing authorization holder, product labeling conditions, approve the version in the language mother of each Member State. In the second half of 2011 have received marketing authorization via the centralized procedure a total of four veterinary medicinal products, presented above.

From medical tradition to traditional medicine: A Tibetan formula in the European framework.

Science.gov (United States)

Schwabl, Herbert; Vennos, Cécile

2015-06-05

The increasing prevalence of complex multi-factorial chronic diseases and multimorbidity reveals the need for an enlargement of the therapeutic options. Potent multicompound herbal formulations from traditional medicine systems such as Tibetan Medicine might meet the requirements. With its practice over the centuries Tibetan Medicine is one of the important medical heritages of the world. In the 20th century Tibetan formulas came to Switzerland, where the formula Gabur-25 was then registered as medicine in 1977 (Padma 28, Swissmedic No 35872). The new European directive 2004/24/EC opened the avenue for traditional herbal medicinal products and registrations followed in Austria (HERB-00037) and the UK (39568/0001). The aim of this review was to analyse not only the critical points and hazards but also chances that occur in the endeavour of bringing a ethnopharmacological based preparation to the market within a modern Western medical and regulatory framework and to discuss the necessary transformation steps from a traditional herbal formula towards a modern pharmaceutical product with the example of the Tibetan formula Gabur-25. The historic transformation process from the 19th to the 21st century is analysed, using the registration documents and other material from the library of Padma AG, Hinwil, Switzerland. The transformation of a traditional formula into a modern traditional herbal medicinal product according to the present EU regulations is a multi faceted process. The modern indication represents only a small part of the possible traditional indications. Quality and product labelling has to be adopted to modern standards. The formula, once registered, is a fixed combination of herbal and mineral ingredients. Contrary to this the concept of Asian medical tradition allows a certain flexibility in the composition of an herbal formula. The ingredients are constantly adapted to local conditions, availability of raw material and therapeutic situation. The example

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: Code of Conduct, Version 2--2008.

LENUS (Irish Health Repository)

McMurray, Janet

2009-01-01

In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 10 years, more than 2000 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Federation of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). A Code of Conduct was adopted in 2003 and a revised and updated version, taking account particularly of the guidelines of the Conseil Européen des Professions Libérales (CEPLIS) of which EFCC is a member, is presented in this article. The revised version was approved by the EC4 Register Commission and by the EFCC Executive Board in Paris on 6 November, 2008.

Clinical evidence for orphan medicinal products-a cause for concern?

NARCIS (Netherlands)

Picavet, Eline; Cassiman, David; Hollak, Carla E.; Maertens, Johan A.; Simoens, Steven

2013-01-01

The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at

41st symposium of the European Space Agency

CERN Document Server

Macchetto, F Duccio

2010-01-01

The Hubble Space Telescope has facilitated major contributions to a wide range of topics in astronomy: The study of nearby planets The processes of star and planet formation The stellar and interstellar components of galaxies The discovery that most, if not all, galactic nuclei harbor a massive black hole that profoundly affects their evolution The realisation that the universe as a whole is undergoing acceleration as a result of a yet unknown form of "dark energy". This volume offers a broad perspective of the advancements made possible by the HST over its almost two decades of operation and emphasises their impact on European astronomical research. These proceedings of 41st symposium in the ESLAB series of the European Space Agency collect the oral and poster papers that were presented and discussed during the meeting.

Cross-Cultural Analysis of Medicinal Plants commonly used in Ethnoveterinary Practices at South Waziristan Agency and Bajaur Agency, Federally Administrated Tribal Areas (FATA), Pakistan.

Science.gov (United States)

Aziz, Muhammad Abdul; Adnan, Muhammad; Khan, Amir Hasan; Sufyan, Muhammad; Khan, Shahid Niaz

2018-01-10

In remote areas, medicinal plants have an imperative role in curing various livestock's ailments. In Pakistan, people residing in remote areas including South Waziristan Agency and Bajaur Agency depend on traditional herbal remedies for treating their domestic animals. Medicinal plants are an important part of the medical system in these Agencies. The prime goal of the current study is to explore the ethnoveterinary practices in the two regions and discuss cross-cultural consensus on the use of medicinal plants. In this study, we have given detailed description on the ethnoveterinary usage of certain medicinal plants and their recipes. Moreover, we have also elaborated the ethnoveterinary potential of certain plants in relation to their ethnomedicinal, pharmacological and phytochemicals reports. Fieldwork comprised of two fields surveys conducted at South Waziristan Agency and Bajaur Agency. A total of 75 informants from South Waziristan Agency and 80 informants from Bajaur Agency were interviewed with the help of semi-structured questionnaires. Use reports (URs) were recorded for all the documented taxa. Data were quantitatively analyzed by using informant consensus factor (F ic ) index in order to find out information homogeneity provided by the informants. To analyze the cross-cultural consensus, the recorded data were tabulated as well as shown by Venn diagram. Overall, 94 medicinal plant taxa were recorded in the comparative analysis. Out of these, most of the plants species (72 species) were used at Bajaur Agency than South Waziristan Agency (37 species). Cross-cultural analysis showed that only 15 medicinal plants were used in common by the indigenous communities in both Agencies, which indicates a low interregional consensus with regard to the ethnoveterinary practices of medicinal plants. Apiaceae was the dominant family in both regions by representing maximum number of plant species (11 species). Gastro intestinal complexities were common in both regions

DTCA of prescription medicines in the European Union: is there still a need for a ban?

Science.gov (United States)

Poser, Mareen

2010-12-01

The pharmaceutical sector is one of the main markets in the European Union. The consumption of medicines is high and steadily increasing. However, the pharmaceutical market is subject to a wider range of restrictions than almost any other sector. The restrictions mainly apply to information provision and advertising practice within the community. One of the main features in pharmaceutical regulation is the ban on direct-to-consumer advertising (DTCA) of prescription medicines. However, an abolition of the ban is controversial in the European Community, especially as the pharmaceutical industry keeps pleading for its ability to use the highly effective marketing strategy of DTCA to promote prescription medicines to the general public. Such advertising is only allowed in two jurisdictions in the world, New Zealand and the United States. In both systems the impact of DTCA on the consumer and the economy has been subject to research. The outcome of these studies is outlined in this article. Since the European Commission has provided a new proposal to amend the current information practice regarding prescription medicines in 2008 (European Commission, Proposal for a Directive of the European Parliament and of the Council Amending, as Regards Information to the General Public on Medicinal Products Subject to Medical Prescription, Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, COM/2008/0663 final) it is time to examine different options to regulate the provision of information and discuss the need for a ban of DTCA.

Annual congress of the European Association of Nuclear Medicine. EANM'14. Abstracts

Energy Technology Data Exchange (ETDEWEB)

NONE

2014-10-15

The proceedings of the annual congress of the European Association of Nuclear Medicine EANM'14 contain abstracts on the following issues: nuclear cardiology practices, PET in lymphoma, advances in nuclear cardiology, dosimetry for intra-arterial treatment in the liver, pediatric nuclear medicine, therapeutic nuclear medicine, SPECT/CT, prostate cancer, extended competencies for nuclear medicine technologists, neurosciences - neurodegeneration and neuroinflammation, radionuclide therapy and dosimetry - preclinical studies, physics and instrumentation, clinical molecular imaging, conventional and specialized nuclear medicine.

Evolution of European Union legislation of herbal medicinal products and its transposition to national legislation in 1965-2007: case Finland.

Science.gov (United States)

Koski, Sari M; Laitinen-Parkkonen, Pirjo; Airaksinen, Marja

2015-01-01

The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007. The study was carried out using content analysis. Data were searched from publicly available European Union directives and national acts. All definitions and safety-related requirements for herbal medicinal products were identified. The transposition of safety-related requirements into the national legislation was studied. Medicinal products from plant origins have been part of the European Union legislation since 1965. Most plant-based products have not initially been regarded as medicinal products but rather as some kind of medicine-like products. The official definition of herbal medicinal products was introduced in Directive 2004/24/EC and implemented into the Finnish legislation with the terminology to recognise herbal medicinal products as part of medicinal products. The current safety-related requirements of medicinal products concern analogously herbal medicinal products. Herbal medicinal products have had different definitions in pharmaceutical legislation over the study period in the European Union and Finland. The current definition places herbal medicinal products more clearly under the medicinal products' legislation. Safety-related requirements are now practically identical for all medicinal products. Transposition of the European Union legislation into the national legislation in Finland is apparent. Copyright © 2013 John Wiley & Sons, Ltd.

White paper of the European Association of Nuclear Medicine (EANM) and the European Society of Radiology (ESR) on multimodality imaging

International Nuclear Information System (INIS)

Bischof Delaloye, Angelika; Carrio, Ignasi; Cuocolo, Alberto; Knapp, Wolfram; Gourtsoyiannis, Nicholas; McCall, Iain; Reiser, Maximilian; Silberman, Bruno

2007-01-01

New multimodality imaging systems bring together anatomical and molecular information and require the competency and accreditation of individuals from both nuclear medicine and radiology. This paper sets out the positions and aspirations of the European Association of Nuclear Medicine (EANM) and the European Society of Radiology (ESR) working together on an equal and constructive basis for the future benefit of both specialties. EANM and ESR recognise the importance of coordinating working practices for multimodality imaging systems and that undertaking the nuclear medicine and radiology components of imaging with hybrid systems requires different skills. It is important to provide adequate and appropriate training in the two disciplines in order to offer a proper service to the patient using hybrid systems. Training models are proposed with the overall objective of providing opportunities for acquisition of special competency certification in multimodality imaging. Both organisations plan to develop common procedural guidelines and recognise the importance of coordinating the purchasing and management of hybrid systems to maximise the benefits to both specialties and to ensure appropriate reimbursement of these examinations. European multimodality imaging research is operating in a highly competitive environment. The coming years will decide whether European research in this area manages to defend its leading position or whether it falls behind research in other leading economies. Since research teams in the Member States are not always sufficiently interconnected, more European input is necessary to create interdisciplinary bridges between research institutions in Europe and to stimulate excellence. EANM and ESR will work with the European Institute for Biomedical Imaging Research (EIBIR) to develop further research opportunities across Europe. European Union grant-funding bodies should allocate funds to joint research initiatives that encompass clinical research

White paper of the European Society of Radiology (ESR) and the European Association of Nuclear Medicine (EANM) on multimodality imaging

International Nuclear Information System (INIS)

Gourtsoyiannis, Nicholas; McCall, Iain; Reiser, Maximilian; Silberman, Bruno; Bischof Delaloye, Angelika; Carrio, Ignacio; Cuocolo, Alberto; Knapp, Wolfram

2007-01-01

New multimodality imaging systems bring together anatomical and molecular information and require the competency and accreditation of individuals from both radiology and nuclear medicine. This paper sets out the positions and aspirations of the European Society of Radiology (ESR) and the European Association of Nuclear Medicine (EANM) working together on an equal and constructive basis for the future benefit of both specialties. ESR and EANM recognise the importance of coordinating working practices for multimodality imaging systems and that undertaking the radiology and nuclear medicine components of imaging with hybrid systems requires different skills. It is important to provide adequate and appropriate training in the two disciplines in order to offer a proper service to the patient using hybrid systems. Training models are proposed with the overall objective of providing opportunities for acquisition of special competency certification in multimodality imaging. Both organisations plan to develop common procedural guidelines and recognise the importance of coordinating the purchasing and management of hybrid systems to maximise the benefits to both specialties and to ensure appropriate reimbursement of these examinations. European multimodality imaging research is operating in a highly competitive environment. The coming years will decide whether European research in this area manages to defend its leading position or whether it falls behind research in other leading economies. Since research teams in the member states are not always sufficiently interconnected, more European input is necessary to create interdisciplinary bridges between research institutions in Europe and to stimulate excellence. ESR and EANM will work with the European Institute for Biomedical Imaging Research (EIBIR) to develop further research opportunities across Europe. European Union grant-funding bodies should allocate funds to joint research initiatives that encompass clinical research

Mapping the Teaching of Laboratory Animal Science and Medicine in the European Union and European Free Trade Area.

Science.gov (United States)

Iatridou, Despoina; Nagy, Zsuzsanna; De Briyne, Nancy; Saunders, Jimmy; Bravo, Ana

2018-06-13

Developing a common market and allowing free movement of goods, services, and people is one of the main objectives of the European Union (EU) and the European Free Trade Area. In the field of scientific research, Directive 2010/63/EU on the protection of animals used for scientific purposes aims to improve the welfare of laboratory animals by following the principle of the 3Rs (replacement, reduction, and refinement). Each breeder, supplier, and user must appoint a designated veterinarian to advise on the well-being and treatment of the animals. In our report we investigate how the undergraduate veterinary curriculum prepares future veterinarians for the role of designated veterinarian, by analyzing data from 77 European veterinary education establishments. Over 80% of them provide training in laboratory animal science and medicine in their curriculum. All countries in the EU and the European Free Trade Area, having national veterinary schools, include such training in the curriculum of at least one of their establishments. Laboratory animal science and medicine courses can be obligatory or elective and are often part of more than one subject in the veterinary curricula. Post-graduate courses or programs are available at more than 50% of those veterinary schools. Most authorities in the European region consider graduate veterinarians ready to seek the role as designated veterinarian immediately after graduation.

A Química Medicinal Brasileira de 1998 a 2008 nos Periódicos Journal of Medicinal Chemistry, Bioorganic and Medicinal Chemistry, Bioorganic and Medicinal Chemistry Letters e European Journal of Medicinal Chemistry

OpenAIRE

Renato S. Bastos; Universidade Federal do Rio de Janeiro; Bárbara V. da Silva; Universidade Federal do Rio de Janeiro; Angelo C. Pinto; Universidade Federal do Rio de Janeiro

2009-01-01

Neste artigo apresentamos as publicações brasileiras, os pesquisadores envolvidos, a contribuição por estado da federação e as principais doenças estudadas no período de 1998 a 2008 nas revistas Journal of Medicinal Chemistry, Bioorganic and Medicinal Chemistry, Bioorganic and Medicinal Chemistry Letters e European Journal of Medicinal Chemistry.  DOI: 10.5935/1984-6835.20090009  In this article we present the Brazilian publications, the research groups involved, the contributions per st...

Quality standards of the European Pharmacopoeia.

Science.gov (United States)

Bouin, Anne-Sophie; Wierer, Michael

2014-12-02

The European Pharmacopoeia (Ph. Eur.) provides a legal and scientific reference for the quality control of medicines. It is legally binding in the 38 signatory parties of the Convention on the elaboration of a European Pharmacopoeia (37 member states and the European Union). The requirements for a specific herbal drug are prescribed in the corresponding individual monograph and the relevant general monographs. Criteria for pesticides and heavy metals for example are defined in the general monograph on Herbal drugs. The Ph. Eur. also provides general methods including methods for determination of aflatoxins B1 and ochratoxin A. Screening methods for aristolochic acids are applied for herbal drugs that may be subject to adulteration or substitution with plant material containing aristolochic acids. The Ph. Eur. collaborate in many areas with the European Medicines Agency (EMA) to ensure close collaboration as regards the respective work programmes and approach. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: guide to the Register, version 3-2010.

LENUS (Irish Health Repository)

McMurray, Janet

2010-07-01

In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 12 years, more than 2200 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Two previous Guides to the Register have been published, one in 1997 and another in 2003. The third version of the Guide is presented in this article and is based on the experience gained and development of the profession since the last revision. Registration is valid for 5 years and the procedure and criteria for re-registration are presented as an Appendix at the end of the article.

European activities in radiation protection in medicine

International Nuclear Information System (INIS)

Simeonov, Georgi

2015-01-01

The recently published Council Directive 2013/59/Euratom ('new European Basic Safety Standards', EU BSS) modernises and consolidates the European radiation protection legislation by taking into account the latest scientific knowledge, technological progress and experience with implementing the current legislation and by merging five existing Directives into a single piece of legislation. The new European BSS repeal previous European legislation on which the national systems for radiation protection in medicine of the 28 European Union (EU) Member States are based, including the 96/29/Euratom 'BSS' and the 97/43/ Euratom 'Medical Exposure' Directives. While most of the elements of the previous legislation have been kept, there are several legal changes that will have important influence over the regulation and practice in the field all over Europe-these include, among others: (i) strengthening the implementation of the justification principle and expanding it to medically exposed asymptomatic individuals, (ii) more attention to interventional radiology, (iii) new requirements for dose recording and reporting, (iv) increased role of the medical physics expert in imaging, (v) new set of requirements for preventing and following up on accidents and (vi) new set of requirements for procedures where radiological equipment is used on people for non-medical purposes (nonmedical imaging exposure). The EU Member States have to enforce the new EU BSS before January 2018 and bring into force the laws, regulations and administrative provisions necessary to comply with it. The European Commission has certain legal obligations and powers to verify the compliance of the national measures with the EU laws and, wherever necessary, issue recommendations to, or open infringement cases against, national governments. In order to ensure timely and coordinated implementation of the new European legal requirements for radiation protection, the Commission is

Which lessons can we learn from the European Union legal framework of medicines for the regulation of direct-to-consumer genetic tests?

Science.gov (United States)

van Hellemondt, Rachèl; Hendriks, Aart; Breuning, Martijn

2012-01-01

The legal framework of the European Union (EU) for regulating access to and supply of direct-to-consumer (DTC) genetic tests is very liberal compared to the legal and regulatory framework for (internet) medicines. Nevertheless, both health related products can cause equally serious damage to the well being of individuals. In this contribution we examine whether the legal framework of the EU for the safety and responsible use of (internet) medicines could be an example for regulating access to and supply of DTC genetic tests. The EU laws governing medicines can, notwithstanding their shortcomings, serve as an example for (central) authorising the marketing of DTC genetic tests on the internal market in accordance with strict criteria regarding predictive value and clinical usefulness. Furthermore, a legal framework controlling DTC genetic tests also should introduce system supervision as well as quality criteria with respect to the information to be provided to consumers in order to enhance health protection. However, DTC genetic tests purchased through online ordering are difficult to supervise by any agency. Adequately protecting individuals against questionable testing kits calls for international vigilance and comprehensive measures by the international community. For Europe, it is important to rank the regulation of DTC genetic tests on the European regulatory agenda.

Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines.

Science.gov (United States)

Johnston, John D; Feldschreiber, Peter

2014-03-01

The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. © 2013 The British Pharmacological Society.

European regulatory tools for advanced therapy medicinal products.

Science.gov (United States)

Flory, Egbert; Reinhardt, Jens

2013-12-01

Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. This class of ATMP integrates gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products and are often individualized and patient-specific products. Multiple challenges arise from the nature of ATMPs, which are often developed by micro, small and medium sized enterprises, university and academia, for whom regulatory experiences are limited and regulatory requirements are challenging. Regulatory guidance such as the reflection paper on classification of ATMPs and guidelines highlighting product-specific issues support academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs. This review provides an overview on the European regulatory aspects of ATMPs and highlights specific regulatory tools such as the ATMP classification procedure, a discussion on the hospital exemption for selected ATMPs as well as borderline issues towards transplants/transfusion products.

Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.

Science.gov (United States)

Pai, Sarayu A; Kshirsagar, Nilima A

2016-11-01

With pioglitazone ban and subsequent revoking in India along with varying regulatory decisions in other countries, it was decided to carry out a systematic review on its safety, efficacy and drug utilization in patients with type 2 diabetes mellitus (T2DM) in India and compare with the data from the European Medicines Agency Assessment Report (EMA-AR). Systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching Medline/PubMed, Google Scholar and Science Direct databases using 'pioglitazone AND India AND human' and 'pioglitazone AND India AND human AND patient' and compared with EMA-AR. Spontaneous reports in World Health Organization VigiBase from India were compared with VigiBase data from other countries. Sixty six publications, 26 (efficacy), 32 (drug utilization) and eight (safety), were retrieved. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. Incidence of bladder cancer in pioglitazone exposed and non-exposed patients was not significantly different in an Indian retrospective cohort study. There were two cases and a series of eight cases of bladder cancer published but none reported in VigiBase. In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

Undergraduate teaching of nuclear medicine: a comparison between Central and Eastern Europe and European Union countries

International Nuclear Information System (INIS)

Lass, P.; Scheffler, J.; Bandurski, T.

2003-01-01

This paper overviews the curricula of nuclear medicine (NM) undergraduate training in 34 Central and Eastern European (CEE) and 37 European Union (EU) medical faculties. The data show enormous variation in the number of hours devoted to nuclear medicine, varying between 1-2 to 40 hours and highly differentiated concepts/ideas of nuclear medicine training in particular countries. In most EU countries this teaching is integrated with that of radiology or clinical modules, also with training in clinical physiology. In many CEE countries teaching and testing of NM are independent, although integration with other teaching modules is frequent. The paper discusses the differences in particular approaches to nuclear medicine teaching. (author)

The technology management process at the European space agency

Science.gov (United States)

Guglielmi, M.; Williams, E.; Groepper, P.; Lascar, S.

2010-03-01

Technology is developed at the European Space Agency (ESA) under several programmes: corporate and domain specific, mandatory and optional, with different time horizons and covering different levels of the TRL scale. To improve the transparency and efficiency of the complete process, it was felt necessary to establish an agreed end to end process for the management of all technology R&D activity that could: Include all ESA programmes and consider the requirements of European users Lead to coordinated multi-year work plan and yearly procurement plans Prepare and enable future European space programmes Be harmonized with national initiatives in Europe Thereby establishing the basis for a product policy to reduce risks to technology users, reduce costs and delays, and enhance industrial competitiveness and non-dependence. In response to the above needs, ESA has developed a technology management process called the ESA End-to-End process (E2E), from establishment of the strategy to the monitoring and evaluation of R&D results. In this paper, the complete process will be described in detail including a discussion on its strengths and limitations, and its links to the wider European Harmonization process. The paper will be concluded with the introduction of the ESA Technology Tree: a basic tool to structure and facilitate communication about technology issues.

Cross-cultural issues in space operations: A survey study among ground personnel of the European Space Agency

Science.gov (United States)

Sandal, Gro Mjeldheim; Manzey, Dietrich

2009-12-01

Today's space operations involve co-working of people with different ethnical, professional and organisational backgrounds. The aim of this study was to examine the implications of cultural diversity for efficient collaboration within the European Space Agency (ESA), and between ESA employees and representatives from other agencies. ESA employees from European countries ( N=576) answered to the CULT Ground Survey. The results showed that differences in relation to leadership and decision making were the most important issues thought to interfere with efficient co-working within ESA, and between ESA employees and colleagues from other agencies. Employees who collaborated with more than three nationalities within ESA indicated most challenges in co-working due to differences in compliance, behavioural norms and competitiveness. Challenges in co-working differed between agencies, and these differences were consistent with value differences in the national populations. The results may have applied value for training of European employees working in international space program teams.

Looking for a Person-Centered Medicine: Non Conventional Medicine in the Conventional European and Italian Setting

Directory of Open Access Journals (Sweden)

Paolo Roberti di Sarsina

2011-01-01

Full Text Available In Italy, the use of non conventional medicines (NCMs is spreading among people as in the rest of Europe. Sales of alternative remedies are growing, and likewise the number of medical doctors (MDs who practise NCM/complementary and alternative medicine (CAM. However, in Italy as in other countries of the European Union, at the present time the juridical/legal status of NCM/CAM is not well established, mainly due to the lack of any national law regulating NCM/CAM professional training, practice and public supply and the absence of government-promoted scientific research in this field. This is an obstacle to safeguarding the patient's interests and freedom of choice, especially now that dissatisfaction with biomedicine is inclining more and more people to look for a holistic and patient-centered form of medicine.

The European Journal of Physical and Rehabilitation Medicine in 2008: a year in a paper.

Science.gov (United States)

Negrini, S

2009-05-01

In 2007, the European Society of Physical and Rehabilitation Medicine (ESPRM) established the European Physical and Rehabilitation Medicine Journal Network (EPRMJN) with a view to increase scientific knowledge among physical and rehabilitation medicine (PRM) specialists and to foster collaboration among the national, regional (multinational) and European PRM journals. In this connection, this paper gives the readers of national and regional, and European PRM journals a complete overview of the European Journal of Physical and Rehabilitation Medicine (EJPRM), the official ESPRM journal, and a review of the papers published in 2008. The evolution of the EJPRM in the last five years was analyzed, and the papers published in 2008 were systematically reviewed and classified by content and discussed. The EJPRM is listed in PubMed and Current Contents; at now the unofficial 2008 Impact Factor is 1.14, like the Impact Factor, also the independent SCImago Journal Rate and Cites per Doc (two years) have increased steadily since 2005. The EJPRM published 72 papers in 2008, with a well balanced coverage of different rehabilitation topics. The rejection rate is around 40%; the review and publication times are 1.2 and 10.0 months, respectively. The published papers are presented here by topic, highlighting multi-journal initiatives (such as the EPRMJN and the Euro-American Focus with the American Journal of PRM), monographic Special Sections, systematic Cochrane PRM reviews, original papers and case reports, and other contents including the Internet Bookshelf. This paper represents the start of the EPRMJN collaborative efforts to increase scientific knowledge among PRM specialists in Europe, independently of the language in which papers are published.

Abstracts of the European Association of Nuclear Medicine congress, 26-30 August 1995, Brussels, Belgium

International Nuclear Information System (INIS)

Anon.

1995-01-01

The issue contains 888 abstracts of lectures and poster sessions of the European Association of Nuclear Medicine Congress held in Brussels, Belgium, from August 26 to 30, 1995. The key subjects adressed are diagnostic nuclear medicine techniques, especially scintiscanning, SPET and PET and their applications in diagnostic medicine. There is an alphabetic index of author names. (vhe) [de

Patient empowerment, an additional characteristic of the European definitions of general practice/family medicine.

Science.gov (United States)

Mola, Ernesto

2013-06-01

Growing evidence supports the inclusion of patient empowerment as a key ingredient of care for patients with chronic conditions. In recent years, several studies based on patient empowerment, have been carried out in different European countries in the context of general practice and primary care to improve management of chronic diseases. These studies have shown good results of the care model, increasing patient and health professionals' satisfaction, adherence to guidelines and to treatment, and improving clinical outcomes. In 2011, the Wonca European Council included as the twelfth characteristic of the European definitions of general practice/family medicine: 'promote patient empowerment'. The aim of this paper is to clarify the meaning of 'patient empowerment' and to explain why family medicine should be considered the most suitable setting to promote it. The inclusion of patient empowerment as one of the essential characteristics of general practice fills a conceptual gap and clearly suggests to the European health care systems a tested model to face chronic diseases: involving and empowering patients in managing their own conditions to improve health and well-being.

European Association of Nuclear Medicine Congress, 14-18 September 1996, Copenhagen, Denmark. Abstracts

International Nuclear Information System (INIS)

Anon.

1996-01-01

The European Association of Nuclear Medicine Congress, held from 14-18 September 1996 in Copenhagen, Denmark, was devoted to all aspects of applications of nuclear medicine for diagnostic evaluation and therapy. The scientific programme and all in all 943 abstracts are presented in this issue, 474 abstracts of scientific lectures and 469 abstracts of poster presentations. There also is an author affiliations index. (VHE) [de

Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency.

Science.gov (United States)

Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis; Poulsen, Henrik Enghusen; Dalhoff, Kim

2017-01-01

To characterize and quantify barriers towards the publication of academic drug trials. We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004. A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412). Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.

Building joint capacity: the role of European Union agencies in the management of trans-boundary crises

NARCIS (Netherlands)

Boin, A.; Busuioc, M.; Groenleer, M.

2011-01-01

This paper focuses on the growing role of European Union (EU) agencies in the management of trans-boundary crises. It makes this development explicit, demonstrating that the emergence of multiple agencies with specific crisis preparation or response tasks has transformed the EU’s crisis management

The OEEC European Nuclear Energy Agency

International Nuclear Information System (INIS)

1961-01-01

The European Nuclear Energy Agency (ENEA) was set up in December 1957 as part of the OEEC to develop nuclear collaboration in Western Europe. The promotion of joint undertakings is one of the most important functions of ENEA, and why one of the first committees of the Agency to be set up was its Top Level Group on Co-operation in the Reactor Field. International collaboration in joint undertakings enables resources in effort, equipment and money to be pooled for the maximum benefit of the countries participating, and is the only way whereby a sufficiently wide range of research possibilities can be covered in a reasonable time. Examples fro such projects are: 1) Halden project - a joint three-year project to exploit the boiling heavy water reactor built by the Norwegian Institute for Atom energy at Halden; 2) Dragon Project - to investigate the possibilities of high-temperature gas-cooled reactors centered on the construction and operation, by an international team, of an experimental 20 MWt high-temperature gas-cooled reactor (Dragon) at the UK Atomic Energy Establishment at Winfrith; 3) Eurochemic - with a principle objective to construct an experimental plant for the treatment of used uranium fuel from reactors in the participating countries; 4) Nuclear Shops. In addition to promoting joint undertakings, a function of ENEA is to encourage scientific and technical collaboration between national research organizations. Co-operation has been facilitated in the areas od nuclear data, food irradiation, environment radioactivity, training, information and nuclear legislation

The OEEC European Nuclear Energy Agency

Energy Technology Data Exchange (ETDEWEB)

NONE

1961-07-15

The European Nuclear Energy Agency (ENEA) was set up in December 1957 as part of the OEEC to develop nuclear collaboration in Western Europe. The promotion of joint undertakings is one of the most important functions of ENEA, and why one of the first committees of the Agency to be set up was its Top Level Group on Co-operation in the Reactor Field. International collaboration in joint undertakings enables resources in effort, equipment and money to be pooled for the maximum benefit of the countries participating, and is the only way whereby a sufficiently wide range of research possibilities can be covered in a reasonable time. Examples fro such projects are: 1) Halden project - a joint three-year project to exploit the boiling heavy water reactor built by the Norwegian Institute for Atom energy at Halden; 2) Dragon Project - to investigate the possibilities of high-temperature gas-cooled reactors centered on the construction and operation, by an international team, of an experimental 20 MWt high-temperature gas-cooled reactor (Dragon) at the UK Atomic Energy Establishment at Winfrith; 3) Eurochemic - with a principle objective to construct an experimental plant for the treatment of used uranium fuel from reactors in the participating countries; 4) Nuclear Shops. In addition to promoting joint undertakings, a function of ENEA is to encourage scientific and technical collaboration between national research organizations. Co-operation has been facilitated in the areas od nuclear data, food irradiation, environment radioactivity, training, information and nuclear legislation.

European guidelines for the certification of professionals in sleep medicine: report of the task force of the European Sleep Research Society.

Science.gov (United States)

Pevernagie, Dirk; Stanley, Neil; Berg, Sören; Krieger, Jean; Amici, Roberto; Bassetti, Claudio; Billiard, Michel; Cirignotta, Fabio; Garcia-Borreguero, Diego; Tobler, Irene; Fischer, Jürgen

2009-03-01

In recent years, sleep medicine has evolved into a full-grown discipline, featuring a multidisciplinary approach to diagnosis and treatment of patients with sleep disorders. Sleep medicine cuts across the boundaries of different conventional disciplines and is therefore open to medical and non-medical professionals with different specialty backgrounds. The aim of the current paper is to introduce a qualification for those professionals whose main occupation is to practice sleep medicine in the setting of a sleep medicine centre. The drafting of guidelines dealing with requirements for such qualification was entrusted to a task force by the European Sleep Research Society. The guidelines are the result of a progressive consensus procedure in which standards were defined for education, training, and evaluation. The final step along this pathway is a theoretical and practical examination, providing proof of proficiency in the field of sleep medicine. This paper describes the object of specific competences, the scope of sleep medicine, and the qualification procedures that pertain to three professional categories: medical specialists, non-medical professionals with a university master degree (such as psychologists and biologists), and nurses and technologists. Indices of preceding practical experience and theoretical knowledge are presented in Appendices 1 and 2. These guidelines are a European standard. They may be adapted in the future according to new scientific insights. National certification programs that comply with these guidelines may be subject to homologation by the ESRS.

The European Standards and Guidelines and the Evaluation of Agencies in Germany

Science.gov (United States)

Hopbach, Achim

2006-01-01

This paper presents preliminary findings from the application of the European Standards and Guidelines (ESG) to the Accreditation Council's accreditation criteria and the review of three German accreditation agencies done by the German Accreditation Council. It focuses on the main characteristics of the ESG and their implementation into the German…

Study on the Evaluation of the European Union Agency for Network and Information Security

DEFF Research Database (Denmark)

Attström, Karin; Ludden, Vanessa; Lessmann, Franziska

The European Union Agency for Network and Information Security (ENISA) was established in 2004. The Agency provides advice and recommendations, data analysis, and supports awareness raising and cooperation by the EU bodies and Member States in the field of cybersecurity. ENISA uses its expertise...... and assesses their financial implications. The findings of the evaluation study show that ENISA has made some important achievements towards increasing NIS in the EU. However, a fragmented approach to cybersecurity across the EU and issues internal to the Agency, including limited financial resources, hinder...

Hybrid cardiac imaging: SPECT/CT and PET/CT. A joint position statement by the European Association of Nuclear Medicine (EANM), the European Society of Cardiac Radiology (ESCR) and the European Council of Nuclear Cardiology (ECNC)

DEFF Research Database (Denmark)

Flotats, Albert; Gutberlet, Matthias; Knuuti, Juhani

2011-01-01

. The European Association of Nuclear Medicine (EANM), the European Society of Cardiac Radiology (ESCR) and the European Council of Nuclear Cardiology (ECNC) in this paper want to present a position statement of the institutions on the current roles of SPECT/CT and PET/CT hybrid cardiac imaging in patients...

Price comparison of high-cost originator medicines in European countries.

Science.gov (United States)

Vogler, Sabine; Zimmermann, Nina; Babar, Zaheer-Ud-Din

2017-04-01

In recent years, high-cost medicines have increasingly been challenging the public health budget in all countries including high-income economies. In this context, this study aims to survey, analyze and compare prices of medicines that likely contribute to high expenditure for the public payers in high-income countries. We chose the following 16 European countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, the Netherlands, Portugal, Sweden, Slovakia, Spain and United Kingdom. The ex-factory price data of 30 medicines in these countries were collected in national databases accessible through the Pharmaceutical Price Information (PPI) service of Gesundheit Österreich GmbH (Austrian Public Health Institute). The ex-factory prices (median) per unit (e.g. per tablet, vial) ranged from 10.67 cent (levodopa + decarboxylase inhibitor) to 17,000 euro (ipilimumab). A total of 53% of the medicines surveyed had a unit ex-factory price (median) above 200 Euro. For two thirds of the medicines, price differences between the highest-priced country and lowest-priced country ranged between 25 and 100%; the remaining medicines, mainly low-priced medicines, had higher price differential, up to 251%. Medicines with unit prices of a few euros or less were medicines for the treatment of diseases in the nervous system (anti-depressants, medicines to treat Parkinson and for the management of neuropathic pain), of obstructive airway diseases and cardio-vascular medicines (lipid modifying agents). High-priced medicines were particularly cancer medicines. Medicine prices of Greece, Hungary, Slovakia and UK were frequently at the lower end, German and Swedish, as well as Danish and Irish prices at the upper end. For high-priced medicines, actual paid prices are likely to be lower due to confidential discounts and similar funding arrangements between industry and public payers. Pricing authorities refer to the higher undiscounted prices when they use

Conference report: formulating better medicines for children: 4th European Paediatric Formulation Initiative conference.

Science.gov (United States)

Walsh, Jennifer; Mills, Simon

2013-01-01

The fourth annual European Paediatric Formulation Initiative (EuPFI) conference on Formulating Better Medicines for Children was held on 19-20 September 2012 at the Institute of Molecular Genetics Congress Centre, Prague, Czech Republic. The 2-day conference concentrated on the latest advances, challenges and opportunities for developing medicinal products and administration devices for pediatric use, both from European and US perspectives. It was aimed specifically at providing exposure to emerging practical applications, and for illustrating remedies utilized by pediatric drug-development teams to overcome hurdles faced in developing medicines for pediatric patients. The conference format included plenary talks, focus sessions on each of the EuPFI work streams (extemporaneous preparations, excipients, pediatric administration devices, taste masking and taste assessment, age-appropriate formulations), case studies, soapbox sessions and a parallel poster display. This conference report summarizes the keynote lectures and also gives a flavor of other presentations and posters from the conference.

International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies.

Science.gov (United States)

Kyte, Derek; Reeve, Bryce B; Efficace, Fabio; Haywood, Kirstie; Mercieca-Bebber, Rebecca; King, Madeleine T; Norquist, Josephine M; Lenderking, William R; Snyder, Claire; Ring, Lena; Velikova, Galina; Calvert, Melanie

2016-02-01

In 2014, the European Medicines Agency (EMA) released for comment a draft reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. A twelve-member International Society for Quality of Life Research (ISOQOL) taskforce was convened to coordinate the ISOQOL response. Twenty-one ISOQOL members provided detailed comments and suggestions on the paper: 81 % from academia and 19 % from industry. Taskforce members consolidated and further refined these comments and shared the recommendations with the wider ISOQOL membership. A final response was submitted to the EMA in November 2014. The impending publication of the EMA reflection paper presents a valuable opportunity for ISOQOL to comment on the current direction of EMA PRO guidance and strategy. The EMA paper, although focused on cancer, could serve as a model for using PROs in other conditions, as it provides a useful update surrounding some of the design issues common to all trial research including PRO endpoints. However, we believe there are a number of additional areas in need of greater consideration. The purpose of this commentary is therefore to highlight the strengths of this timely and potentially useful document, but also to outline areas that may warrant further discussion.

Research projects in family medicine funded by the European Union.

Science.gov (United States)

Pavličević, Ivančica; Barać, Lana

2014-01-01

This study aimed at synthesizing funding opportunities in the field of family medicine by determining the number of family medicine projects, as well as number of project leaderships and/ or participations by each country. This was done in order to encourage inclusion of physicians in countries with underdeveloped research networks in successful research networks or to encourage them to form new ones. We searched the Community Research and Development Information Service project database in February 2013. Study covered the period from years 1992 - 2012, selecting the projects within the field of general/family medicine. The search was conducted in February 2013. First search conducted in the CORDIS database came up with a total of 466 projects. After excluding 241 projects with insufficient data, we analysed 225 remaining projects; out of those, 22 (9.8%) were in the field of family medicine and 203 (90.2%) were from other fields of medicine. Sorted by the number of projects per country, Dutch institutions had the highest involvement in family medicine projects and were partners or coordinators in 18 out of 22 selected projects (81.8%), followed by British institutions with 15 (68.8%), and Spanish with 10 projects (45.5%). Croatia was a partner in a single FP7 Health project. Research projects in family medicine funded by the European Union show significant differences between countries. Constant and high-quality international cooperation in family medicine is the prerequisite for improvement and development of scientific research and the profession. Copyright © 2014 by Academy of Sciences and Arts of Bosnia and Herzegovina.

Driven by expertise and insulation?: the autonomy of European regulatory agencies

OpenAIRE

Ossege, Christoph

2015-01-01

Expertise and autonomy are cornerstones to the effective operation and legitimacy of European Regulatory Agencies (ERAs). Yet, we know little about ERAs' actual autonomy, nor about factors shaping it. This article studies ERAs' actual autonomy from public and private actors, emphasising two crucial explanatory factors: expertise and rulemaking competences. The lack of insights on expertise is particularly striking, as expertise -the "raison d'être" and main resource of expert bodies- provides...

Respiratory medicines for children: current evidence, unlicensed use and research priorities

DEFF Research Database (Denmark)

Smyth, A R; Barbato, A; Beydon, N

2010-01-01

deficiency. We hope that this summary of the evidence for respiratory medicines in children, highlighting gaps and research priorities, will be useful for the pharmaceutical industry, the paediatric committee of the European Medicines Agency, academic investigators and the lay public.......This European Respiratory Society task force has reviewed the evidence for paediatric medicines in respiratory disease occurring in adults and children. We describe off-licence use, research priorities and ongoing studies. Off-licence and off-label prescribing in children is widespread...... and potentially harmful. Research areas in asthma include novel formulations and regimens, and individualised prescribing. In cystic fibrosis, future studies will focus on screened infants and robust outcome measures are needed. Other areas include new enzyme and antibiotic formulations and the basic defect...

From Ejtm (European Journal of Translational Myology) to Ejt3M (European Journal of Translational Myology, Mobility, Medicine)

Science.gov (United States)

Adamo, Sergio

2018-01-01

This first 2018 Issue of the European Journal of Translational Myology presents many novelties, that are demonstrating that the journal is vital and expanding its authorship, readership and relevance from focused fields of biology, physiology, diagnostic, management and rehabilitation of skeletal muscle tissue to the more interesting and clinical relevant fields of human mobility up to those of general medicine. The Editorial Board is consequently expanded to allow fair and expert evaluation of more broadly interests and expertise of the Authors submitting typescripts. We are considering the option to move the name of the journal from Ejtm to Ejt3M (Myology, Mobility, Medicine). Criticisms and suggestions are welcomed. PMID:29686824

Evaluation of Herbal Medicines: Value Addition to Traditional Medicines Through Metabolism, Pharmacokinetic and Safety Studies.

Science.gov (United States)

Thelingwani, Roslyn; Masimirembwa, Collen

2014-01-01

The safety and efficacy of herbal medicines remain major issues of concern especially in the developing world where the use is high. The World Health Organisation estimates up to 80% of the population in Africa relies on herbal medicines for treatment of many diseases. Minimum safety evaluations need to be done for both the herbal and conventional drugs, in particular when there is a high likelihood of co-administration. This is particularly important in Africa where there is increased access to antiretrovirals in the treatment of HIV/AIDS, which are being used in a population background characterized by rampant use of herbal medicines. Many techniques used in the discovery and evaluation of conventional drugs can be adapted to herbal medicines. Such evaluations will add value to herbal medicines as doctors and patients will be better informed on which drugs and herbal medicines to take or not take together. This can also lead to the adoption of guidelines by regulatory agents such as the European Medicines Agency (EMA), Food and Drug Administration (FDA) and governmental agencies controlling the use of medicines. Of current interest is the evaluation of drug-herb interactions (DHI) involving the absorption, distribution, metabolism and excretion (ADME) of medicines where there is a promising possibility to adopt the current FDA and EMA guidelines on the evaluation of herbal medicines for drug-drug interactions (DDI). In this review we demonstrate progress made so far in DHI and point to possible future developments that will contribute to the safe use of herbal medicines.

Description of European Space Agency (ESA) Concept Development for a Mars Sample Receiving Facility (MSRF)

Science.gov (United States)

Vrublevskis, J.; Berthoud, L.; Guest, M.; Smith, C.; Bennett, A.; Gaubert, F.; Schroeven-Deceuninck, H.; Duvet, L.; van Winnendael, M.

2018-04-01

This presentation gives an overview of the several studies conducted for the European Space Agency (ESA) since 2007, which progressively developed layouts for a potential implementation of a Mars Sample Receiving Facility (MSRF).

[European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

Science.gov (United States)

Zhu, You-Ping

2017-06-01

This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union（EU）, and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

Scandinavian Fellowship for Oral Pathology and Oral Medicine: statement on oral pathology and oral medicine in the European Dental Curriculum

DEFF Research Database (Denmark)

Kragelund, C; Reibel, J; Hadler-Olsen, E S

2010-01-01

source in revisions of dental curricula throughout Europe converging towards a European Dental Curriculum. In order to render the best conditions for future curriculum revisions providing the best quality dentist we feel obliged to analyse and comment the outlines of oral pathology and oral medicine...

The actual development of European aviation safety requirements in aviation medicine: prospects of future EASA requirements.

Science.gov (United States)

Siedenburg, J

2009-04-01

Common Rules for Aviation Safety had been developed under the aegis of the Joint Aviation Authorities in the 1990s. In 2002 the Basic Regulation 1592/2002 was the founding document of a new entity, the European Aviation Safety Agency. Areas of activity were Certification and Maintenance of aircraft. On 18 March the new Basic Regulation 216/2008, repealing the original Basic Regulation was published and applicable from 08 April on. The included Essential Requirements extended the competencies of EASA inter alia to Pilot Licensing and Flight Operations. The future aeromedical requirements will be included as Annex II in another Implementing Regulation on Personnel Licensing. The detailed provisions will be published as guidance material. The proposals for these provisions have been published on 05 June 2008 as NPA 2008- 17c. After public consultation, processing of comments and final adoption the new proposals may be applicable form the second half of 2009 on. A transition period of four year will apply. Whereas the provisions are based on Joint Aviation Requirement-Flight Crew Licensing (JAR-FCL) 3, a new Light Aircraft Pilot Licence (LAPL) project and the details of the associated medical certification regarding general practitioners will be something new in aviation medicine. This paper consists of 6 sections. The introduction outlines the idea of international aviation safety. The second section describes the development of the Joint Aviation Authorities (JAA), the first step to common rules for aviation safety in Europe. The third section encompasses a major change as next step: the foundation of the European Aviation Safety Agency (EASA) and the development of its rules. In the following section provides an outline of the new medical requirements. Section five emphasizes the new concept of a Leisure Pilot Licence. The last section gives an outlook on ongoing rulemaking activities and the opportunities of the public to participate in them.

You Can't Eat Biodiversity: Agency and Irrational Norms in European Aquatic Environmental Law

Directory of Open Access Journals (Sweden)

Tim G. O'Higgins

2017-02-01

Full Text Available Policies of the European Union cover a range of social, environmental and economic aspirations and the current environmental directives and laws have evolved from a suite of norms which have changed over time. These may be characterised loosely according to 'Three Ps': Practical, those taking an anthropocentric approach; Pure, those taking an ecocentric approach and Popular, those appealing to the general public. In this paper I use these three perspectives as a tool to analyse the complexity and identify contradictions in European aquatic environmental legislation. Some trade-offs between development and conservation are identified and used to characterise the potential qualities of more successful agency to achieve environmental goals in the governance of European aquatic environments.

Legal Barriers in Accessing Opioid Medicines : Results of the ATOME Quick Scan of National Legislation of Eastern European Countries

NARCIS (Netherlands)

Vranken, Marjolein J M; Mantel-Teeuwisse, Aukje K; Jünger, Saskia; Radbruch, Lukas; Lisman, John; Scholten, Willem; Payne, Sheila; Lynch, Tom; Schutjens, Marie-Hélène D B

2014-01-01

CONTEXT: Overregulation of controlled medicines is one of the factors contributing to limited access to opioid medicines. OBJECTIVES: The purpose of this study was to identify legal barriers to access to opioid medicines in 12 Eastern European countries participating in the Access to Opioid

Initiatives driving accelerated access to medicines in Europe: Review of recent concepts and developments

Directory of Open Access Journals (Sweden)

Mia Gannedahl

2018-03-01

Full Text Available Improving timely patient access to new medicines, particularly in areas with high unmet need, has been a healthcare priority during the past 5–10 years, with several new regulatory initiatives from the European Medicines Agency, as well as on national level within the European Union. Nevertheless, evidence suggests that medicines going through these regulatory initiatives experience variable reimbursement outcomes due to uncertainties in the clinical or economic evidence base. New initiatives, including the adaptive pathways concept, have therefore been introduced that embrace a holistic view of a medicine’s route to patient access. These involve expanded clusters of stakeholders working together to prospectively influence and design evidence generation strategies, including use of real-world evidence, to ensure that development plans meet the needs of multiple stakeholders including regulatory agencies and health technology assessment bodies. Multi-stakeholder dialogues, provided through scientific advice, are already available for medicines in Europe in various forms and are important tools for regulators, health technology assessment bodies and pharmaceutical companies to develop evidence generation plans optimised to support decision-making on marketing authorisation and reimbursement of new medicines. Multiple stakeholder groups have been actively engaged in advancing developments of initiatives driving timely access and it is likely to continue due to the need to balance this with affordability. The aim of this article is to provide a review of the latest, as well as a future perspective on, developments with respect to accelerated access of medicines in the European Union with a particular focus on procedures for formal scientific advice.

Comprehensive Auditing in Nuclear Medicine Through the International Atomic Energy Agency Quality Management Audits in Nuclear Medicine (QUANUM) Program. Part 1: the QUANUM Program and Methodology.

Science.gov (United States)

Dondi, Maurizio; Torres, Leonel; Marengo, Mario; Massardo, Teresa; Mishani, Eyal; Van Zyl Ellmann, Annare; Solanki, Kishor; Bischof Delaloye, Angelika; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Paez, Diana; Pascual, Thomas

2017-11-01

An effective management system that integrates quality management is essential for a modern nuclear medicine practice. The Nuclear Medicine and Diagnostic Imaging Section of the International Atomic Energy Agency (IAEA) has the mission of supporting nuclear medicine practice in low- and middle-income countries and of helping them introduce it in their health-care system, when not yet present. The experience gathered over several years has shown diversified levels of development and varying degrees of quality of practice, among others because of limited professional networking and limited or no opportunities for exchange of experiences. Those findings triggered the development of a program named Quality Management Audits in Nuclear Medicine (QUANUM), aimed at improving the standards of NM practice in low- and middle-income countries to internationally accepted standards through the introduction of a culture of quality management and systematic auditing programs. QUANUM takes into account the diversity of nuclear medicine services around the world and multidisciplinary contributions to the practice. Those contributions include clinical, technical, radiopharmaceutical, and medical physics procedures. Aspects of radiation safety and patient protection are also integral to the process. Such an approach ensures consistency in providing safe services of superior quality to patients. The level of conformance is assessed using standards based on publications of the IAEA and the International Commission on Radiological Protection, and guidelines from scientific societies such as Society of Nuclear Medicine and Molecular Imaging (SNMMI) and European Association of Nuclear Medicine (EANM). Following QUANUM guidelines and by means of a specific assessment tool developed by the IAEA, auditors, both internal and external, will be able to evaluate the level of conformance. Nonconformances will then be prioritized and recommendations will be provided during an exit briefing. The

Towards a European strategy for medicines research (2014-2020): The EUFEPS position paper on Horizon 2020.

Science.gov (United States)

Gaspar, Rogério; Aksu, Buket; Cuine, Alain; Danhof, Meindert; Takac, Milena Jadrijevic-Mladar; Linden, Hans H; Link, Andreas; Muchitsch, Eva-Maria; Wilson, Clive G; Ohrngren, Per; Dencker, Lennart

2012-12-18

As to the alignment of "Horizon 2020", ir is a more integrated approach to European science policy than expressed in the proposals previously drafted, and specifically considers: (i) promoting excellence in Science, (ii) establishing a sound industrial leadership and (iii) expressing an ambition to address current and future societal challenges. In this respect, the quest for a knowledge-based economy in Europe should result in proposals for industrial and employment policies that will consolidate the major European advantages in the biomedical, healthcare and pharmaceutical sectors. Horizon 2020 also provides the possibility of adopting a more flexible and simplified management route to drive European research through innovation, research and development. What should be additionally considered? Unmet medical needs, under pressure from demographic changes, await the generation of new medicines and health technologies which will evolve into a driver for a unified European policy. We believe that this should be focused on harnessing pharmaceutical knowledge for clinical use, as part of a response to accommodate patient needs and economic growth based on a robust, scientific approach. The bolder ambition for European research is to unlock key bottlenecks currently undermining European competitiveness. The historical lack of an appropriate business/innovation environment with reduced access to adequate risk finance instruments has severed the path for economic growth and industrial development. These issues are of critical importance and a solution is urgently needed to foster translation from the university to the healthcare sector through the generation and support of start-ups, spin-offs, university-industry consortia, and other platforms, which support translational research. The ultimate goal is implementation of holistic programmes: the 'bench to bedside' paradigm of medicines and other healthcare products. The European Research Council supports the basic

European Medicines Agency Perspective on Oncology Study Design for Marketing Authorization and Beyond.

Science.gov (United States)

Jonsson, B; Martinalbo, J; Pignatti, F

2017-05-01

In the development of highly active anticancer drugs, the European situation may be viewed as paradoxical. Limited data may support marketing authorization, but may be insufficient for the health economic appraisal needed for reimbursement and market uptake. To achieve this, conventional confirmatory studies may be needed. For products of special interest, studies aimed at optimizing cost-effectiveness may be warranted. Efficient designs of studies to meet these objectives constitute challenges to all stakeholders. © 2017 ASCPT.

Nuclear Medicine in Turkey

International Nuclear Information System (INIS)

Durak, H.

2001-01-01

Nuclear Medicine is a medical specialty that uses radionuclides for the diagnosis and treatment of diseases and it is one of the most important peaceful applications of nuclear sciences. Nuclear Medicine has a short history both in Turkey and in the world. The first use of I-131 for the treatment of thyrotoxicosis in Turkey was in 1958 at the Istanbul University Cerrahpasa Medical School. In 1962, Radiobiological Institute in Ankara University Medical School was established equipped with well-type counters, radiometers, scalers, external counters and a rectilinear scanner. In 1965, multi-probe external detection systems, color dot scanners and in 1967, anger scintillation camera had arrived. In 1962, wet lab procedures and organ scanning, in 1965 color dot scanning, dynamic studies (blood flow - renograms) and in 1967 analogue scintillation camera and dynamic camera studies have started. In 1974, nuclear medicine was established as independent medical specialty. Nuclear medicine departments have started to get established in 1978. In 1974, The Turkish Society of Nuclear Medicine (TSNM) was established with 10 members. The first president of TSNM was Prof. Dr. Yavuz Renda. Now, in the year 2000, TSNM has 349 members. Turkish Society of Nuclear Medicine is a member of European Association of Nuclear Medicine (EANM), World Federation of Nuclear Medicine and Biology (WFNMB) and WFNMB Asia-Oceania. Since 1974, TSNM has organized 13 national Nuclear Medicine congresses, 4 international Nuclear Oncology congresses and 13 nuclear medicine symposiums. In 1-5 October 2000, 'The VII th Asia and Oceania Congress of Nuclear Medicine and Biology' was held in Istanbul, Turkey. Since 1992, Turkish Journal of Nuclear Medicine is published quarterly and it is the official publication of TSNM. There are a total of 112 Nuclear Medicine centers in Turkey. There are 146 gamma cameras. (52 Siemens, 35 GE, 16 Elscint, 14 Toshiba, 10 Sopha, 12 MIE, 8 Philips, 9 Others) Two cyclotrons are

Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.

Science.gov (United States)

Lis, Yvonne; Roberts, Melissa H; Kamble, Shital; J Guo, Jeff; Raisch, Dennis W

2012-12-01

1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs. We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%). Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Introduction of European priority review vouchers to encourage development of new medicines for neglected diseases.

Science.gov (United States)

Ridley, David B; Sánchez, Alfonso Calles

2010-09-11

Every year 1 billion people worldwide are affected by traditionally neglected diseases, such as malaria, tuberculosis, leishmaniasis, and lymphatic filariasis, which impose tremendous public health burdens. Governments, foundations, and drug manufacturers have, however, started to support development of new treatments. European Union Member States have been leaders in implementing so-called push mechanisms (payment for drug development) and pull funding (reward for output), such as the advance market commitment, which creates a market for vaccines by guaranteeing prices. We propose an additional step that could be taken to encourage development of medicines for neglected diseases. A priority review voucher scheme, as is already in place in the USA, would reward a manufacturer that developed a new medicine for neglected diseases with a voucher that could be redeemed for priority review of a future medicine, probably a potential blockbuster drug. Unlike the US system a European voucher would also accelerate pricing and reimbursement decisions. This scheme would be likely to provide substantial benefits to voucher holders, society, and public health organisations. Copyright 2010 Elsevier Ltd. All rights reserved.

[Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products].

Science.gov (United States)

Qu, Li-Ping; Zhang, Xiao-Qun; Xiong, Yan; Wang, Yi-Tao; Zou, Wen-Jun

2017-10-01

Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU. Copyright© by the Chinese Pharmaceutical Association.

[The European network of transfusion medicine societies (EuroNet-TMS): The White Book 2005].

Science.gov (United States)

Rouger, P

2005-06-01

Europe is building up. It develops in a quite complex environment, in which health care represents an important field of activities. As for blood transfusion, it plays a major role especially in the development of medical activities as well as for the patients treatments. Today, blood components are still of human origin and there are no substitutes for them. As a medical discipline, Blood Transfusion represents a broad field in medicine which requests the involvement of numerous actors. It is up to professional medical/scientific societies to promote the discipline. This is why it has been considered necessary and relevant to build up a federation of transfusion medicine societies throughout the European Union (EU) ; it is called EuroNet-TMS, the European Network of Transfusion Medicine Societies. This network groups more than 7500 professionals of involved in blood transfusion activities. It has six major objectives: 1) To find coherent responses to issues at stake in transfusion; 2) To promote medical and scientific developments of blood transfusion in Europe; 3) To ensure the highest and most up-to-date scientific level to meet safety and quality standards; 4) To offer similar services to all EU citizens in the field of blood transfusion; 5) To share knowledge and date within Europe; 6) To develop interfaces with decision-makers among the diverse European countries. The first step is the writing of the "White Book 2005" which reports the state of the art of blood transfusion in Europe; a prospective plan is proposed to be discussed.

Multimodality imaging in Europe: a survey by the European Association of Nuclear Medicine (EANM) and the European Society of Radiology (ESR)

International Nuclear Information System (INIS)

Cuocolo, Alberto; Breatnach, Eamann

2010-01-01

Multimodality imaging represents an area of rapid growth with important professional implication for both nuclear medicine physicians and radiologists throughout Europe. As a preliminary step for future action aimed at improving the quality and accessibility of PET/SPECT/CT multimodality imaging practice in Europe, the European Association of Nuclear Medicine (EANM) and the European Society of Radiology (ESR) performed a survey among the individual membership of both societies to obtain information on the status of multimodality imaging in their facilities and their future visions on training for combined modalities. A questionnaire was forwarded to all individual members of the EANM and ESR. The main subject matter of the questionnaire related to: (1) study performance, current procedures, current equipment including its supervisory personnel at respondents' individual facilities and (2) vision of future practice, performance and the potential for combined interdisciplinary viewing and training for future professionals. The reporting and the billing procedures of multimodality imaging studies are very heterogeneous in European countries. The majority of the members of both societies believe that the proportion of PET/CT conducted as a full diagnostic CT with contrast enhancement will increase over time. As expected, 18 F-FDG is the most commonly used PET tracer for clinical applications. The large majority of respondents were in favour of an interdisciplinary training programme being developed on a European level together by the EANM and the ESR and the respective sections of the European Union of Medical Specialists. The results of this survey show that there is wide heterogeneity in the current practice of multimodality imaging in Europe. This situation may limit the full potential and integration of multimodality imaging within the clinical arena. There is a strong desire within both specialties for the development of interdisciplinary training to address some

Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

Science.gov (United States)

Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

2015-01-01

With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

European medicinal polypores--a modern view on traditional uses.

Science.gov (United States)

Grienke, Ulrike; Zöll, Margit; Peintner, Ursula; Rollinger, Judith M

2014-07-03

In particular five polypore species, i.e. Laetiporus sulphureus, Fomes fomentarius, Fomitopsis pinicola, Piptoporus betulinus, and Laricifomes officinalis, have been widely used in central European folk medicines for the treatment of various diseases, e.g. dysmenorrhoea, haemorrhoids, bladder disorders, pyretic diseases, treatment of coughs, cancer, and rheumatism. Prehistoric artefacts going back to over 5000 years underline the long tradition of using polypores for various applications ranging from food or tinder material to medicinal-spiritual uses as witnessed by two polypore species found among items of Ötzi, the Iceman. The present paper reviews the traditional uses, phytochemistry, and biological activity of the five mentioned polypores. All available information on the selected polypore taxa used in traditional folk medicine was collected through evaluation of literature in libraries and searches in online databases using SciFinder and Web of Knowledge. Mycochemical studies report the presence of many primary (e.g. polysaccharides) and secondary metabolites (e.g. triterpenes). Crude extracts and isolated compounds show a wide spectrum of biological properties, such as anti-inflammatory, cytotoxic, and antimicrobial activities. The investigated polypores possess a longstanding ethnomycological tradition in Europe. Here, we compile biological results which highlight their therapeutic value. Moreover, this work provides a solid base for further investigations on a molecular level, both compound- and target-wise. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Extremity exposure in nuclear medicine: Preliminary results of a European study

International Nuclear Information System (INIS)

Merce, M. S.; Ruiz, N.; Barth, I.; Carnicer, A.; Donadille, L.; Ferrari, P.; Fulop, M.; Ginjaume, M.; Gualdrini, G.; Krim, S.; Mariotti, F.; Ortega, X.; Rimpler, A.; Vanhavere, F.; Baechler, S.

2011-01-01

The Work Package 4 of the ORAMED project, a collaborative project (2008-11) supported by the European Commission within its seventh Framework Programme, is concerned with the optimisation of the extremity dosimetry of medical staff in nuclear medicine. To evaluate the extremity doses and dose distributions across the hands of medical staff working in nuclear medicine departments, an extensive measurement programme has been started in 32 nuclear medicine departments in Europe. This was done using a standard protocol recording all relevant information for radiation exposure, i.e. radiation protection devices and tools. This study shows the preliminary results obtained for this measurement campaign. For diagnostic purposes, the two most-used radionuclides were considered: 99m Tc) and 18 F. For therapeutic treatments, Zevalin R and DOTATOC (both labelled with 90 Y) were chosen. Large variations of doses were observed across the hands depending on different parameters. Furthermore, this study highlights the importance of the positioning of the extremity dosemeter for a correct estimate of the maximum skin doses. (authors)

Comparative analysis of specialization in palliative medicine processes within the World Health Organization European region.

Science.gov (United States)

Centeno, Carlos; Bolognesi, Deborah; Biasco, Guido

2015-05-01

Palliative medicine (PM), still in the development phase, is a new, growing specialty aimed at caring for both oncology and non-oncology patients. There is still confusion about the training offered in the various European PM certification programs. To provide a detailed, comparative update and analysis of the PM certification process in Europe, including the different training approaches and their main features. Experts from each country completed an online survey addressing historical background, program name, training requirements, length of time in training, characteristic and content, official certifying institution, effectiveness of accreditation, and 2013 workforce capacity. We prepared a comparative analysis of the data provided. In 2014, 18 of 53 European countries had official programs on specialization in PM (POSPM): Czech Republic, Denmark, Finland, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Latvia, Malta, Norway, Poland, Portugal, Romania, Slovakia, and the U.K. Ten of these programs were begun in the last five years. The PM is recognized as a "specialty," "subspecialty," or "special area of competence," with no substantial differences between the last two designations. The certification contains the term "palliative medicine" in most countries. Clinical training varies, with one to two years being the most frequent duration. There is a clear trend toward establishing the POSPM as a mandatory condition for obtaining a clinical PM position in countries' respective health systems. PM is growing as a specialization field in Europe. Processes leading to certification are generally long and require substantial clinical training. The POSPM education plans are heterogeneous. The European Association for Palliative Care should commit to establishing common learning standards, leading to additional European-based recognition of expertise in PM. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All

[Report from the Committee for Advanced Therapies (CAT). Pitfalls on the way from concept to medical treatment with advanced therapy medicinal products].

Science.gov (United States)

Reiss, M; Büttel, I C; Schneider, C K

2011-07-01

Advanced therapy medicinal products (ATMP) are highly innovative and complex medicines. They comprise gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products (TEP). With the European Regulation on ATMP that came into force in 2008, a consolidated regulatory framework was created, where the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) plays a central role. This article discusses pitfalls and challenges that the CAT has experienced in its discussions of various procedures. Often ATMPs are developed by small and medium-sized enterprises (SME) which also face nonscientific challenges. The CAT wishes to meet these challenges on a scientific and regulatory level during its 2010-2015 work program.

Nurse prescribing of medicines in Western European and Anglo-Saxon countries: a survey on forces, conditions and jurisdictional control.

NARCIS (Netherlands)

Kroezen, M.; Francke, A.L.; Groenewegen, P.P.; Dijk, L. van

2012-01-01

Background: The number of Western European and Anglo-Saxon countries where nurses are legally allowed to prescribe medicines is growing. As the prescribing of medicines has traditionally been the task of the medical profession, nurse prescribing is changing the relationship between the medical and

Towards European urinalysis guidelines. Introduction of a project under European Confederation of Laboratory Medicine.

Science.gov (United States)

Kouri, T T; Gant, V A; Fogazzi, G B; Hofmann, W; Hallander, H O; Guder, W G

2000-07-01

Improved standardized performance is needed because urinalysis continues to be one of the most frequently requested laboratory tests. Since 1997, the European Confederation of Laboratory Medicine (ECLM) has been supporting an interdisciplinary project aiming to produce European urinalysis guidelines. More than seventy clinical chemists, microbiologists and ward-based clinicians, as well as representatives of manufacturers are taking part. These guidelines aim to improve the quality and consistency of chemical urinalysis, particle counting and bacterial culture by suggesting optimal investigative processes that could be applied in Europe. The approach is based on medical needs for urinalysis. The importance of the pre-analytical stage for total quality is stressed by detailed illustrative advice for specimen collection. Attention is also given to emerging automated technology. For cost containment reasons, both optimum (ideal) procedures and minimum analytical approaches are suggested. Since urinalysis mostly lacks genuine reference methods (primary reference measurement procedures; Level 4), a novel classification of the methods is proposed: comparison measurement procedures (Level 3), quantitative routine procedures (Level 2), and ordinal scale examinations (Level 1). Stepwise strategies are suggested to save costs, applying different rules for general and specific patient populations. New analytical quality specifications have been created. After a consultation period, the final written text will be published in full as a separate document.

Medical physics in Europe following recommendations of the International Atomic Energy Agency

International Nuclear Information System (INIS)

Casar, Bozidar; Lopes, Maria do Carmo; Drljević, Advan; Gershkevitsh, Eduard; Pesznyak, Csilla

2016-01-01

Medical physics is a health profession where principles of applied physics are mostly directed towards the application of ionizing radiation in medicine. The key role of the medical physics expert in safe and effective use of ionizing radiation in medicine was widely recognized in recent European reference documents like the European Union Council Directive 2013/59/EURATOM (2014), and European Commission Radiation Protection No. 174, European Guidelines on Medical Physics Expert (2014). Also the International Atomic Energy Agency (IAEA) has been outspoken in supporting and fostering the status of medical physics in radiation medicine through multiple initiatives as technical and cooperation projects and important documents like IAEA Human Health Series No. 25, Roles and Responsibilities, and Education and Training Requirements for Clinically Qualified Medical Physicists (2013) and the International Basic Safety Standards, General Safety Requirements Part 3 (2014). The significance of these documents and the recognition of the present insufficient fulfilment of the requirements and recommendations in many European countries have led the IAEA to organize in 2015 the Regional Meeting on Medical Physics in Europe, where major issues in medical physics in Europe were discussed. Most important outcomes of the meeting were the recommendations addressed to European member states and the survey on medical physics status in Europe conducted by the IAEA and European Federation of Organizations for Medical Physics. Published recommendations of IAEA Regional Meeting on Medical Physics in Europe shall be followed and enforced in all European states. Appropriate qualification framework including education, clinical specialization, certification and registration of medical physicists shall be established and international recommendation regarding staffing levels in the field of medical physics shall be fulfilled in particular. European states have clear legal and moral

Medical physics in Europe following recommendations of the International Atomic Energy Agency.

Science.gov (United States)

Casar, Bozidar; Lopes, Maria do Carmo; Drljević, Advan; Gershkevitsh, Eduard; Pesznyak, Csilla

2016-03-01

Medical physics is a health profession where principles of applied physics are mostly directed towards the application of ionizing radiation in medicine. The key role of the medical physics expert in safe and effective use of ionizing radiation in medicine was widely recognized in recent European reference documents like the European Union Council Directive 2013/59/EURATOM (2014), and European Commission Radiation Protection No. 174, European Guidelines on Medical Physics Expert (2014). Also the International Atomic Energy Agency (IAEA) has been outspoken in supporting and fostering the status of medical physics in radiation medicine through multiple initiatives as technical and cooperation projects and important documents like IAEA Human Health Series No. 25, Roles and Responsibilities, and Education and Training Requirements for Clinically Qualified Medical Physicists (2013) and the International Basic Safety Standards, General Safety Requirements Part 3 (2014). The significance of these documents and the recognition of the present insufficient fulfilment of the requirements and recommendations in many European countries have led the IAEA to organize in 2015 the Regional Meeting on Medical Physics in Europe, where major issues in medical physics in Europe were discussed. Most important outcomes of the meeting were the recommendations addressed to European member states and the survey on medical physics status in Europe conducted by the IAEA and European Federation of Organizations for Medical Physics. Published recommendations of IAEA Regional Meeting on Medical Physics in Europe shall be followed and enforced in all European states. Appropriate qualification framework including education, clinical specialization, certification and registration of medical physicists shall be established and international recommendation regarding staffing levels in the field of medical physics shall be fulfilled in particular. European states have clear legal and moral

Medical physics in Europe following recommendations of the International Atomic Energy Agency

Science.gov (United States)

Lopes, Maria do Carmo; Drljević, Advan; Gershkevitsh, Eduard; Pesznyak, Csilla

2016-01-01

Background Medical physics is a health profession where principles of applied physics are mostly directed towards the application of ionizing radiation in medicine. The key role of the medical physics expert in safe and effective use of ionizing radiation in medicine was widely recognized in recent European reference documents like the European Union Council Directive 2013/59/EURATOM (2014), and European Commission Radiation Protection No. 174, European Guidelines on Medical Physics Expert (2014). Also the International Atomic Energy Agency (IAEA) has been outspoken in supporting and fostering the status of medical physics in radiation medicine through multiple initiatives as technical and cooperation projects and important documents like IAEA Human Health Series No. 25, Roles and Responsibilities, and Education and Training Requirements for Clinically Qualified Medical Physicists (2013) and the International Basic Safety Standards, General Safety Requirements Part 3 (2014). The significance of these documents and the recognition of the present insufficient fulfilment of the requirements and recommendations in many European countries have led the IAEA to organize in 2015 the Regional Meeting on Medical Physics in Europe, where major issues in medical physics in Europe were discussed. Most important outcomes of the meeting were the recommendations addressed to European member states and the survey on medical physics status in Europe conducted by the IAEA and European Federation of Organizations for Medical Physics. Conclusions Published recommendations of IAEA Regional Meeting on Medical Physics in Europe shall be followed and enforced in all European states. Appropriate qualification framework including education, clinical specialization, certification and registration of medical physicists shall be established and international recommendation regarding staffing levels in the field of medical physics shall be fulfilled in particular. European states have clear

Condensed tannins in extracts from European medicinal plants and herbal products.

Science.gov (United States)

Ropiak, Honorata M; Ramsay, Aina; Mueller-Harvey, Irene

2016-03-20

Medicinal plant materials are not usually analysed for condensed tannins (CT). Thirty commercially available European medicinal plants and herbal products were screened for CT and fourteen CT samples were analysed in detail. This is also the first comprehensive CT analysis of pine buds, walnut leaves, heather flowers and great water dock roots. Acetone/water extracts contained between 3.2 and 25.9 g CT/100g of extract, had CT with mean degrees of polymerisation of 2.9 to 13.3, procyanidin/prodelphinidin ratios of 1.6/98.4 to 100/0 and cis/trans flavan-3-ol ratios of 17.7/82.3 to 97.3/2.7. The majority of samples contained procyanidins, four contained A-type linkages (blackthorn flowers, heather flowers, bilberry leaves and cowberry leaves) and one sample also had galloylated procyanidins (great water dock roots). Copyright © 2015 Elsevier B.V. All rights reserved.

Drones in medicine-The rise of the machines.

Science.gov (United States)

Balasingam, Manohari

2017-09-01

This is a medical kitty hawk moment. Drones are pilotless aircrafts that were initially used exclusively by the military but are now also used for various scientific purposes, public safety, and in commercial industries. The healthcare industry in particular can benefit from their technical capabilities and ease of use. Common drone applications in medicine include the provision disaster assessments when other means of access are severely restricted; delivering aid packages, medicines, vaccines, blood and other medical supplies to remote areas; providing safe transport of disease test samples and test kits in areas with high contagion; and potential for providing rapid access to automated external defibrillators for patients in cardiac arrest. Drones are also showing early potential to benefit geriatric medicine by providing mobility assistance to elderly populations using robot-like technology. Looking further to the future, drones with diagnostic imaging capabilities may have a role in assessing health in remote communities using telemedicine technology. The Federal Aviation Administration (FAA) in the United States and the European Aviation Safety Agency (EASA) in the European Union are some examples of legislative bodies with regulatory authority over drone usage. These agencies oversee all technical, safety, security and administrative issues related to drones. It is important that drones continue to meet or exceed the requirements specified in each of these regulatory areas. The FAA is challenged with keeping pace legislatively with the rapid advances in drone technology. This relative lag has been perceived as slowing the proliferation of drone use. Despite these regulatory limitations, drones are showing significant potential for transforming healthcare and medicine in the 21st century. © 2017 John Wiley & Sons Ltd.

EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: version 3 - 2005.

Science.gov (United States)

Zerah, Simone; McMurray, Janet; Bousquet, Bernard; Baum, Hannsjorg; Beastall, Graham H; Blaton, Vic; Cals, Marie-Josèphe; Duchassaing, Danielle; Gaudeau-Toussaint, Marie-Françoise; Harmoinen, Aimo; Hoffmann, Hans; Jansen, Rob T; Kenny, Desmond; Kohse, Klaus P; Köller, Ursula; Gobert, Jean-Gérard; Linget, Christine; Lund, Erik; Nubile, Giuseppe; Opp, Matthias; Pazzagli, Mario; Pinon, Georges; Queralto, José M; Reguengo, Henrique; Rizos, Demetrios; Szekeres, Thomas; Vidaud, Michel; Wallinder, Hans

2006-01-01

The EC4 Syllabus for Postgraduate Training is the basis for the European Register of Specialists in Clinical Chemistry and Laboratory Medicine. The syllabus: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. The syllabus is not primarily meant to be a training guide, but on the basis of the overview given (common minimal programme), national societies should formulate programmes that indicate where knowledge and experience is needed. The main points of this programme are: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory management; and Quality insurance management. The aim of this version of the syllabus is to be in accordance with the Directive of Professional Qualifications published on 30 September 2005. To prepare the common platforms planned in this directive, the disciplines are divided into four categories: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory

Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

Directory of Open Access Journals (Sweden)

Janis eAncans

2012-08-01

Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries.

Science.gov (United States)

Vogler, Sabine; Paris, Valérie; Ferrario, Alessandra; Wirtz, Veronika J; de Joncheere, Kees; Schneider, Peter; Pedersen, Hanne Bak; Dedet, Guillaume; Babar, Zaheer-Ud-Din

2017-06-01

This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the hospital and offpatent outpatient sectors has been proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.

EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management

Directory of Open Access Journals (Sweden)

Luc Van Bortel

2018-01-01

Full Text Available The first formal conference of the EUropean Federation for Exploratory MEdicines Development (EUFEMED held in London was the result of a collaborative effort of its founding associations: the Association for Applied Human Pharmacology (AGAH; Germany, the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI; UK, the Belgian Association of Phase-I Units (BAPU; Belgium, and Club Phase-I (France. The conference focused on innovation and risk management in early clinical drug development. Among other innovations, immunotherapy in oncology and inflammatory diseases were discussed as well as the importance of adaptive trial designs in early clinical drug development. Consideration was given to assessing and mitigating risk in early clinical drug development, and included a preconference workshop. Different measures to minimize risks in healthy volunteers and patients in first-in-human trials were discussed in addition to the importance of non-clinical data, the need for reliable biomarkers, improved communication on adverse events (AEs and well-trained study sites with ready access to intensive care units and clinical specialists. The need for a European-wide system for prevention of over-volunteering was also discussed. The conference provided opportunity to discuss these developments and concerns and the changing regulatory environment with stakeholders from academia, industry, and regulatory agencies including the European Medicines Agency (EMA. Presentations given by invited speakers are published on http://www.eufemed.eu/london-conference-2017/.

EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management.

Science.gov (United States)

Van Bortel, Luc; Sourgens, Hildegard; Breithaupt-Grögler, Kerstin; Caplain, Henri; Donazzolo, Yves; Klingmann, Ingrid; Hammond, Michael; Hardman, Timothy C; Stringer, Steffan; de Hoon, Jan

2017-01-01

The first formal conference of the EUropean Federation for Exploratory MEdicines Development (EUFEMED) held in London was the result of a collaborative effort of its founding associations: the Association for Applied Human Pharmacology (AGAH; Germany), the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI; UK), the Belgian Association of Phase-I Units (BAPU; Belgium), and Club Phase-I (France). The conference focused on innovation and risk management in early clinical drug development. Among other innovations, immunotherapy in oncology and inflammatory diseases were discussed as well as the importance of adaptive trial designs in early clinical drug development. Consideration was given to assessing and mitigating risk in early clinical drug development, and included a preconference workshop. Different measures to minimize risks in healthy volunteers and patients in first-in-human trials were discussed in addition to the importance of non-clinical data, the need for reliable biomarkers, improved communication on adverse events (AEs) and well-trained study sites with ready access to intensive care units and clinical specialists. The need for a European-wide system for prevention of over-volunteering was also discussed. The conference provided opportunity to discuss these developments and concerns and the changing regulatory environment with stakeholders from academia, industry, and regulatory agencies including the European Medicines Agency (EMA). Presentations given by invited speakers are published on http://www.eufemed.eu/london-conference-2017/.

Does the market share of generic medicines influence the price level?: a European analysis.

Science.gov (United States)

Dylst, Pieter; Simoens, Steven

2011-10-01

After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited. This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets. Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007. Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries. The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents.

Science.gov (United States)

Leong Wai Yeen, James; Salek, Sam; Walker, Stuart

2014-01-01

The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

Science.gov (United States)

Kondo, Hideyuki; Saint-Raymond, Agnès; Yasuda, Naoyuki

2018-03-01

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU. Taking into account the increasing number of global clinical trials and constant number of consultations or scientific advice related to global clinical trials in Japan, it is clear that the importance of the continuous, collaborative relationship between EMA and PMDA is more and more crucial, as it does facilitate close and timely exchange of information and opinions on products and technologies under development. There already are effective collaborative frameworks between PMDA and EMA in addition to daily communication, and our findings support the development and best use of regulatory tools such as consultation services and scientific advice/protocol assistance for the benefit of the pharmaceutical industry but mostly of patients.

40 years of biannual family medicine research meetings--the European General Practice Research Network (EGPRN).

Science.gov (United States)

Buono, Nicola; Thulesius, Hans; Petrazzuoli, Ferdinando; Van Merode, Tiny; Koskela, Tuomas; Le Reste, Jean-Yves; Prick, Hanny; Soler, Jean Karl

2013-12-01

To document family medicine research in the 25 EGPRN member countries in 2010. Semi-structured survey with open-ended questions. Academic family medicine in 23 European countries, Israel, and Turkey. 25 EGPRN national representatives. Demographics of the general population and family medicine. Assessments, opinions, and suggestions. EGPRN has represented family medicine for almost half a billion people and > 300,000 general practitioners (GPs). Turkey had the largest number of family medicine departments and highest density of GPs, 2.1/1000 people, Belgium had 1.7, Austria 1.6, and France 1.5. Lowest GP density was reported from Israel 0.17, Greece 0.18, and Slovenia 0.4 GPs per 1000 people. Family medicine research networks were reported by 22 of 25 and undergraduate family medicine research education in 20 of the 25 member countries, and in 10 countries students were required to do research projects. Postgraduate family medicine research was reported by 18 of the member countries. Open-ended responses showed that EGPRN meetings promoted stimulating and interesting research questions such as comparative studies of chronic pain management, sleep disorders, elderly care, healthy lifestyle promotion, mental health, clinical competence, and appropriateness of specialist referrals. Many respondents reported a lack of interest in family medicine research related to poor incentives and low family medicine status in general and among medical students in particular. It was suggested that EGPRN exert political lobbying for family medicine research. Since 1974, EGPRN organizes biannual conferences that unite and promote primary care practice, clinical research and academic family medicine in 25 member countries.

Writing a case report for the American Journal of Physical Medicine & Rehabilitation and the European Journal of Physical and Rehabilitation Medicine.

Science.gov (United States)

Ozçakar, Levent; Franchignoni, Franco; Negrini, Stefano; Frontera, Walter

2013-02-01

Case reports (CRs) have led to the description and discovery of new diseases, syndromes, therapeutic complications or side effects, and previously unknown potential benefits of pharmacologic agents. CRs may also be used as an effective training strategy for novice authors to develop the skills needed for medical writing. However, too often, CRs do not follow standards for excellence in scientific writing. Therefore, in this article, the American Journal of Physical Medicine & Rehabilitation and the European Journal of Physical and Rehabilitation Medicine collaborate with the purpose of providing guidance to authors in selecting CRs that might be appropriate for publication. In addition, the authors discuss different aspects of the preparation of a well written CR in accordance with the mission and editorial views of both journals.

Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome

DEFF Research Database (Denmark)

Bueno, Héctor; de Graeff, Pieter; Richard-Lordereau, Isabelle

2016-01-01

syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic...... researchers, trialists, European and US regulators, and pharmaceutical industry researchers. Specific questions in four key areas were selected as priorities for changes in regulatory guidance: patient selection, endpoints, methodologic issues and issues related to the research for novel agents. Patients......Regulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary...

EU FP7 project 'CAMbrella' to build European research network for complementary and alternative medicine

DEFF Research Database (Denmark)

Weidenhammer, Wolfgang; Lewith, George; Falkenberg, Torkel

2011-01-01

BACKGROUND: The status of complementary and alternative medicine (CAM) within the EU needs clarification. The definition and terminology of CAM is heterogeneous. The therapies, legal status, regulations and approaches used vary from country to country but there is widespread use by EU citizens...... governing CAM provision, and to explore the needs and attitudes of EU citizens with respect to CAM. Based on this information a roadmap will be created that will enable sustainable and prioritised future European research in CAM. CAMbrella encompasses 16 academic research groups from 12 European countries...... review open access publications and a final conference, with emphasis on current and future EU policies, addressing different target audiences....

The European General Practice Research Network Presents the Translations of Its Comprehensive Definition of Multimorbidity in Family Medicine in Ten European Languages

Science.gov (United States)

Le Reste, Jean Yves; Nabbe, Patrice; Rivet, Charles; Lygidakis, Charilaos; Doerr, Christa; Czachowski, Slawomir; Lingner, Heidrun; Argyriadou, Stella; Lazic, Djurdjica; Assenova, Radost; Hasaganic, Melida; Munoz, Miquel Angel; Thulesius, Hans; Le Floch, Bernard; Derriennic, Jeremy; Sowinska, Agnieska; Van Marwijk, Harm; Lietard, Claire; Van Royen, Paul

2015-01-01

Background Multimorbidity, according to the World Health Organization, exists when there are two or more chronic conditions in one patient. This definition seems inaccurate for the holistic approach to Family Medicine (FM) and long-term care. To avoid this pitfall the European General Practitioners Research Network (EGPRN) designed a comprehensive definition of multimorbidity using a systematic literature review. Objective To translate that English definition into European languages and to validate the semantic, conceptual and cultural homogeneity of the translations for further research. Method Forward translation of the EGPRN’s definition of multimorbidity followed by a Delphi consensus procedure assessment, a backward translation and a cultural check with all teams to ensure the homogeneity of the translations in their national context. Consensus was defined as 70% of the scores being higher than 6. Delphi rounds were repeated in each country until a consensus was reached Results 229 European medical expert FPs participated in the study. Ten consensual translations of the EGPRN comprehensive definition of multimorbidity were achieved. Conclusion A comprehensive definition of multimorbidity is now available in English and ten European languages for further collaborative research in FM and long-term care. PMID:25607642

Guidelines for MIBG-scintigraphy in children; Empfehlungen zur Durchfuehrung der MIBG-Szintigraphie bei Kindern. Leitlinie uebernommen vom Paediatric Committee der European Association of Nuclear Medicine (EANM)

Energy Technology Data Exchange (ETDEWEB)

Olivier, P. [CHU Nancy (France); Colarinha, P. [Inst. Portugues de Oncologia, Lisbon (Portugal); Fettich, J. [Univ. Medical Centre Ljubljana (Slovenia); Fischer, S.; Hahn, K.; Porn, U. [Klinik fuer Nuklearmedizin, Univ. of Munich (Germany); Froekier, J. [Aarhus Univ. Hospital - Skejby (Denmark); Giammarile, F. [Centre Leon Berard, Lyon (France); Gordon, I. [Great Ormond Street Hospital for Children, London (United Kingdom); Kabasakal, L. [Cerraphasa Tipp Fakultesi, Nukleer Tipp Ana Bilim Dali, Aksaray (Turkey); Mann, M. [Red Cross Hospital Cape Town (South Africa); Mitjavila, M. [Hospital Universitario de Getafe, Madrid (Spain); Piepsz, A. [AZ VUB and CHU St Pierre, Brussels (Belgium); Sixt, R. [Sahlgrenska Univ. Hospital Oestra, Goeteborg (Sweden); Velzen, J. van [ARPES (Netherlands)

2002-07-01

These ''Empfehlungen'' are the german translation of the Guidelines on MIBG-Scintigraphy in Children, which were published by the Paediatric Committee of the European Association of Nuclear Medicine. (orig.) [German] Bei den vorliegenden Empfehlungen handelt es sich um die deutsche Uebersetzung der vom Paediatric Committee der European Association of Nuclear Medicine (EANM) publizierten Guidelines. (orig.)

Guidelines for direct radionuclide cystography; Empfehlungen zur Durchfuehrung der direkten Radionuklid-Zystographie bei Kindern. Richtlinie uebernommen vom Paediatric Committee der European Association of Nuclear Medicine (EANM)

Energy Technology Data Exchange (ETDEWEB)

Fettich, J. [Univ. Medical Centre Ljubljana (Slovenia); Colarinha, P. [Inst. Portugues de Oncologia, Lisboa (Portugal); Fischer, S.; Hahn, K.; Porn, U. [Klinik fuer Nuklearmedizin, LMU Muenchen (Germany); Froekier, J. [Aarhus Univ. Hospital - Skejby (Denmark); Gordon, I. [Great Ormond Street Hospital for Children, London (United Kingdom); Kabasakal, L. [Cerraphasa Tip Fakultesi, Nukleer Tip Ana Bilim Dali, Aksaray (Turkey); Mann, M. [Inst. of Child Health, Rondebosh, Red Cross Hospital, Capetown (South Africa); Mitjavila, M. [Hospital Universitario de Getafe, Madrid (Spain); Olivier, P. [CHU Nancy (France); Piepsz, A. [CHU St Pierre (Belgium); Roca, I. [Hospital Vall d' Hebron, Barcelona (Spain); Sixt, R. [The Queen Silvia Children' s Hospital, Goeteborg (Sweden); Velzen, J. van [ARPES (Netherlands)

2002-07-01

These ''Empfehlungen'' are the german translation of the Guidelines on MIBG-Scintigraphy in Children, which were published by the Paediatric Committee of the European Association of Nuclear Medicine. (orig.) [German] Bei den vorliegenden Empfehlungen handelt es sich um die deutsche Uebersetzung der vom Paediatric Committee der European Association of Nuclear Medicine (EANM) publizierten Guidelines. (orig.)

A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.

Science.gov (United States)

Amato, Antonino; Aringhieri, Eugenio; Boccia, Stefania; Buccella, Filippo; Gorini, Barbara; Gramaglia, Donatella; Masetti, Riccardo; Rossi, Paolo; Pelicci, Pier Giuseppe

2017-01-01

The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.

Herbal medicines: challenges in the modern world. Part 2. European Union and Russia.

Science.gov (United States)

Sammons, Helen M; Gubarev, Michael I; Krepkova, Lubov V; Bortnikova, Valentina V; Corrick, Fenella; Job, Kathleen M; Sherwin, Catherine Mt; Enioutina, Elena Y

2016-08-01

Herbal medicines (HMs) have been well known to people of the European Union (EU) and Russia for centuries. Currently, Western HMs can be classified into two categories, plant-derived conventional medicines and dietary supplements. Interest to HMs has grown rapidly in all countries during the past two decades. The main goal of this review article is to present the history of HMs in the EU and Russia, forms of modern HMs, including Oriental Medicines that are popular among consumers of both countries. Additional discussion points comprise safety and adulteration issues associated with HMs, including regulatory changes and new legislative measures undertaken by the authorities. Materials available from legislative and governmental websites, PubMed and news media were used. Expert commentary: Due to cultural diversities in the EU and Russia, traditional HMs of other regions, particularly Chinese Traditional and Ayurvedic medicines, are also popular. Recently, dietary supplements containing multiple herbal and other natural products have flooded the EU and Russian markets. Pharmacovigilance in these markets is challenging in terms of establishing quality and safety of ingredients, determining efficacy, and defining risks of herb-herb and herb-drug interactions. Both the EU and Russia have introduced new legislation aimed to overcome these deficiencies.

Decisions by regulatory agencies: are they evidence-based?

Directory of Open Access Journals (Sweden)

Furberg Curt D

2007-04-01

Full Text Available Abstract Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based. For the selective COX-2 inhibitors, there are clear contraindications and warnings in Europe, but only a vaguely worded Black Box warning in the United States. All the non-selective agents are given an almost "clean bill of health" in Europe, while all of them are judged to have a similar risk-benefit ratio as celecoxib in the United States. The regulatory agencies have failed to recognize the clinical trial evidence that the risk of cardiovascular events varies substantially among the non-selective agents, with diclofenac carrying the highest risk of harm.

Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

Science.gov (United States)

Ancans, Janis

2012-01-01

Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

1st Joint European Conference on Therapeutic Targets and Medicinal Chemistry (TTMC 2015)

Science.gov (United States)

Le Borgne, Marc; Haidar, Samer; Duval, Olivier; Wünsch, Bernhard; Jose, Joachim

2015-01-01

The European Conference on Therapeutic Targets and Medicinal Chemistry is a new two-day meeting on drug discovery that is focused on therapeutic targets and the use of tools to explore all fields of drug discovery and drug design such as molecular modelling, bioorganic chemistry, NMR studies, fragment screening, in vitro assays, in vivo assays, structure activity relationships, autodisplay. Abstracts of keynote lectures, plenary lectures, junior lectures, flash presentations, and posters presented during the meeting are collected in this report. PMID:26712767

Towards a line-of-sight, implementation of performance measurement by road agencies : A European and Western Australian perspective

NARCIS (Netherlands)

Schoenmaker, R.; Van der Lei, T.T.E.

2015-01-01

This paper is the result of an international, explorative study of the alignment of government and road authority goals from different European countries and Western Australia. The goal of the study is to advance the understanding of the development of performance management of road agencies.

Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.

Science.gov (United States)

Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

2015-05-01

On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT.

European undergraduate curriculum in geriatric medicine developed using an international modified Delphi technique

DEFF Research Database (Denmark)

Masud, T.; Blundell, A.; Gordon, A. L.

2014-01-01

Introduction: the rise in the number of older, frail adults necessitates that future doctors are adequately trained in the skills of geriatric medicine. Few countries have dedicated curricula in geriatric medicine at the undergraduate level. The aim of this project was to develop a consensus among...... geriatricians on a curriculum with the minimal requirements that a medical student should achieve by the end of medical school. Methods: a modified Delphi process was used. First, educational experts and geriatricians proposed a set of learning objectives based on a literature review. Second, three Delphi...... rounds involving a panel with 49 experts representing 29 countries affiliated to the European Union of Medical Specialists (UEMS) was used to gain consensus for a final curriculum. Results: the number of disagreements following Delphi Rounds 1 and 2 were 81 and 53, respectively. Complete agreement...

Publication rate of abstracts presented at the emergency medicine congresses held by the European Society for Emergency Medicine (EUSEM) in 2011 and 2012.

Science.gov (United States)

Kalkan, Asim; Kose, Ozkan; Bilir, Ozlem; Ersunan, Gokhan; Ozel, Deniz; Guler, Ferhat

2015-09-01

The purpose of this study was to assess the publication rate of the abstracts presented at the 6th Mediterranean Emergency Medicine Congress, 2011 and the 7th European Congress on Emergency Medicine, 2012. All abstracts, both posters and oral presentations, from the international emergency medicine congresses held by the European Society for Emergency Medicine (EUSEM) in 2011 and 2012 were identified. To establish whether these abstracts were subsequently published in peer-reviewed medical journals, the names of all the authors and the title of the abstracts were searched for in the databases of Clinical Key/Elsevier, EBSCO Discovery Service, MD Consult, Science Direct, Scopus, EMBASE, Medscape, Google Scholar and local ULAKBIM. The year of publication, consistency of author names and titles, the type of study, the journals in which papers were published and countries from which reports were submitted were all recorded. A total of 1721 abstracts were examined; 626 from 2011 (307 oral presentations and 319 posters) and 1095 from 2012 (154 oral presentations and 941 posters). Of all abstracts in 2011, 172 (27.5%) and of all abstracts in 2012, 265 (24.2%) were subsequently published as full-text reports in peer-reviewed journals. Of the 172 papers published in 2011, 152 (88.4%) were accepted by Science Citation Index (SCI) and/or SCI Expanded (SCI-E) journals and 155 (58.5%) of 265 papers were accepted by SCI and/or SCI-E journals in 2012 (p=0.0001). The publication rate of abstracts submitted to international emergency medicine congresses held by EUSEM over those 2 years was low compared with that of abstracts presented in other emergency medicine congresses. Presenters should be encouraged to send their studies to peer-reviewed journals. During the selection process by the scientific panel, constructive critics should be notified to the presenters instead of simply accepting or rejecting the studies that submitted to the congress, which may increase the

Writing a case report for the American Journal of Physical Medicine and Rehabilitation and the European Journal of Physical and Rehabilitation Medicine.

Science.gov (United States)

Özçakar, L; Franchignoni, F; Frontera, W; Negrini, S

2013-04-01

Case reports (CR) have led to the description and discovery of new diseases, syndromes, therapeutic complications or side-effects, and previously unknown potential benefits of pharmacologic agents. CRs may also be used as an effective training strategy for novice authors to develop the skills needed for medical writing. Yet, too often, CRs do not follow standards for excellence in scientific writing. Therefore, in this article, the American Journal of Physical Medicine and Rehabilitation (AJPMR) and the European Journal of Physical and Rehabilitation Medicine (EJPRM) collaborate with the purpose of providing guidance to authors in selecting CRs that might be appropriate for publication. In addition, we discuss different aspects of the preparation of a well-written CR in accordance with the mission and editorial views of both journals.

Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market – Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014

Science.gov (United States)

Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A.; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

2015-01-01

On September 11, 2014, a workshop entitled ‘Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market’ was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT. PMID:26195933

The European Medicines Agency Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult Patients With Relapsed or Refractory CD30+ Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use.

Science.gov (United States)

Gravanis, Iordanis; Tzogani, Kyriaki; van Hennik, Paula; de Graeff, Pieter; Schmitt, Petra; Mueller-Berghaus, Jan; Salmonson, Tomas; Gisselbrecht, Christian; Laane, Edward; Bergmann, Lothar; Pignatti, Francesco

2016-01-01

On October 25, 2012, a conditional marketing authorization valid throughout the European Union (EU) was issued for brentuximab vedotin for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL) and for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). For HL, the indication is restricted to treatment after autologous stem cell transplantation (ASCT) or after at least two previous therapies when ASCT or multiagent chemotherapy is not a treatment option. Brentuximab vedotin is an antibody-drug conjugate (ADC) composed of a CD30-directed monoclonal antibody (recombinant chimeric IgG1) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE). Binding of the ADC to CD30 on the cell surface initiates internalization of the MMAE-CD30 complex, followed by proteolytic cleavage that releases MMAE. The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Brentuximab vedotin as a single agent was evaluated in two single-arm studies. Study SG035-003 included 102 patients with relapsed or refractory HL. An objective response was observed in 76 patients (75%), with complete remission in 34 (33%). Study SG035-004 included 58 patients with relapsed or refractory sALCL. An objective response was observed in 50 patients (86%), with complete remission in 34 (59%). The most frequently observed toxicities were peripheral sensory neuropathy, fatigue, nausea, diarrhea, neutropenia, vomiting, pyrexia, and upper respiratory tract infection. The present report summarizes the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of the product characteristics, are available on the European Medicines Agency website (http://www.ema.europa.eu). Brentuximab vedotin was approved in the European Union for the treatment of adult

Validation of the American Society for Reproductive Medicine guidelines/recommendations in white European men presenting for couple's infertility.

Science.gov (United States)

Ventimiglia, Eugenio; Capogrosso, Paolo; Boeri, Luca; Ippolito, Silvia; Scano, Roberta; Moschini, Marco; Gandaglia, Giorgio; Papaleo, Enrico; Montorsi, Francesco; Salonia, Andrea

2016-10-01

To retrospectively validate the American Society for Reproductive Medicine (ASRM) guidelines/recommendations concerning endocrine evaluation in a cohort of white European men presenting for couple's infertility. Retrospective study. Academic reproductive medicine outpatient clinic. Cohort of 1,056 consecutive infertile men (noninterracial infertile couples). Testicular volume was assessed with a Prader orchidometer. Serum hormones were measured (8-10 a.m.) in all cases. Hypogonadism was defined as total T Society definition. Semen analysis values were assessed based on the 2010 World Health Organisation reference criteria. ASRM indications for endocrine assessment in infertile men (sperm concentration Society classification criteria. Conversely, 37 (23.7%) out of 156 patients with biochemical hypogonadism would have been overlooked. The overall predictive accuracy, sensitivity, and specificity of the ASRM guidelines was 58%, 76%, and 39%, respectively. Our nomogram was not reliable enough to predict hypogonadism, despite demonstrating a significantly higher predictive accuracy (68%) than the ASRM guidelines. The current findings show that the ASRM guidelines/recommendations for male infertility workup may not be suitable for application in white European infertile men. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

New Tools to Search for Data in the European Space Agency's Planetary Science Archive

Science.gov (United States)

Grotheer, E.; Macfarlane, A. J.; Rios, C.; Arviset, C.; Heather, D.; Fraga, D.; Vallejo, F.; De Marchi, G.; Barbarisi, I.; Saiz, J.; Barthelemy, M.; Docasal, R.; Martinez, S.; Besse, S.; Lim, T.

2016-12-01

The European Space Agency's (ESA) Planetary Science Archive (PSA), which can be accessed at http://archives.esac.esa.int/psa, provides public access to the archived data of Europe's missions to our neighboring planets. These datasets are compliant with the Planetary Data System (PDS) standards. Recently, a new interface has been released, which includes upgrades to make PDS4 data available from newer missions such as ExoMars and BepiColombo. Additionally, the PSA development team has been working to ensure that the legacy PDS3 data will be more easily accessible via the new interface as well. In addition to a new querying interface, the new PSA also allows access via the EPN-TAP and PDAP protocols. This makes the PSA data sets compatible with other archive-related tools and projects, such as the Virtual European Solar and Planetary Access (VESPA) project for creating a virtual observatory.

[Classification of cell-based medicinal products and legal implications: An overview and an update].

Science.gov (United States)

Scherer, Jürgen; Flory, Egbert

2015-11-01

In general, cell-based medicinal products do not represent a uniform class of medicinal products, but instead comprise medicinal products with diverse regulatory classification as advanced-therapy medicinal products (ATMP), medicinal products (MP), tissue preparations, or blood products. Due to the legal and scientific consequences of the development and approval of MPs, classification should be clarified as early as possible. This paper describes the legal situation in Germany and highlights specific criteria and concepts for classification, with a focus on, but not limited to, ATMPs and non-ATMPs. Depending on the stage of product development and the specific application submitted to a competent authority, legally binding classification is done by the German Länder Authorities, Paul-Ehrlich-Institut, or European Medicines Agency. On request by the applicants, the Committee for Advanced Therapies may issue scientific recommendations for classification.

Seventh European Workshop on Cannabinoid Research and IACM Eighth Conference on Cannabinoids in Medicine

OpenAIRE

Cheer, Joseph F.; Maccarrone, Mauro; Piomelli, Daniele

2016-01-01

Abstract The joint 7th European Workshop on Cannabinoid Research and IACM 8th Conference on Cannabinoids in Medicine was held in the beach town of Sestri Levante, Italy, on September 17?19, 2015. In this beautiful setting, world-leading investigators in the field of (endo)cannabinoid research presented exciting new data spanning a broad array of preclinical and clinical topics?from cellular electrophysiology to drug discovery and from potential indications for the therapeutic use of cannabis ...

[The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].

Science.gov (United States)

Berger, A; Schüle, S; Flory, E

2011-07-01

Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

Global view on radiation protection in medicine

International Nuclear Information System (INIS)

Vano, E.

2011-01-01

When planning good management of ionising radiation in medicine, key factors such as ensuring that health professionals work together and convincing them that radiation protection (RP) represents a substantial part of the quality management system in their clinical practice are of utmost importance. The United Nations Scientific Committee on the Effects of Atomic Radiation has decided that one of the thematic priorities will be medical radiation exposure of patients. The International Commission on Radiological Protection has recently updated the report on RP in medicine and continues to work on focused documents centred on specific areas where advice is needed. The roles of the International Atomic Energy Agency, World Health Organization and the European Commission, in the area of RP in medicine, are described in the present document. The industry, the standardisation organisations as well as many scientific and professional societies are also dedicating significant effort to radiation safety aspects in medicine. Some of the efforts and priorities contemplated in RP in medicine over the coming years are suggested. The best outcome will be accomplished when all the actors, i.e. medical doctors, other health professionals, regulators, health authorities and the industry manage to work together. (authors)

The European Journal of Case Reports in Internal Medicine – The First Two Years

Directory of Open Access Journals (Sweden)

John Kellett

2016-06-01

Full Text Available The European Journal of Case Reports in Internal Medicine (EJCRIM is just over two years old. To date 400 reports have been submitted and just under half have been accepted for publication. In order to keep costs down our initial policy was to charge a small fee for all submissions, and a further small publication fee for papers that were accepted. However, we have now abolished the submission charge and replaced it with a single, slightly increased, publication charge for all accepted papers.

European Society for Swallowing Disorders – European Union Geriatric Medicine Society white paper: oropharyngeal dysphagia as a geriatric syndrome

Science.gov (United States)

Baijens, Laura WJ; Clavé, Pere; Cras, Patrick; Ekberg, Olle; Forster, Alexandre; Kolb, Gerald F; Leners, Jean-Claude; Masiero, Stefano; Mateos-Nozal, Jesús; Ortega, Omar; Smithard, David G; Speyer, Renée; Walshe, Margaret

2016-01-01

This position document has been developed by the Dysphagia Working Group, a committee of members from the European Society for Swallowing Disorders and the European Union Geriatric Medicine Society, and invited experts. It consists of 12 sections that cover all aspects of clinical management of oropharyngeal dysphagia (OD) related to geriatric medicine and discusses prevalence, quality of life, and legal and ethical issues, as well as health economics and social burden. OD constitutes impaired or uncomfortable transit of food or liquids from the oral cavity to the esophagus, and it is included in the World Health Organization’s classification of diseases. It can cause severe complications such as malnutrition, dehydration, respiratory infections, aspiration pneumonia, and increased readmissions, institutionalization, and morbimortality. OD is a prevalent and serious problem among all phenotypes of older patients as oropharyngeal swallow response is impaired in older people and can cause aspiration. Despite its prevalence and severity, OD is still underdiagnosed and untreated in many medical centers. There are several validated clinical and instrumental methods (videofluoroscopy and fiberoptic endoscopic evaluation of swallowing) to diagnose OD, and treatment is mainly based on compensatory measures, although new treatments to stimulate the oropharyngeal swallow response are under research. OD matches the definition of a geriatric syndrome as it is highly prevalent among older people, is caused by multiple factors, is associated with several comorbidities and poor prognosis, and needs a multidimensional approach to be treated. OD should be given more importance and attention and thus be included in all standard screening protocols, treated, and regularly monitored to prevent its main complications. More research is needed to develop and standardize new treatments and management protocols for older patients with OD, which is a challenging mission for our societies

Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007-15: Report from the Medical Products Agency.

Science.gov (United States)

Svedlund, Erika; Larsson, Maria; Hägerkvist, Robert

2017-06-01

In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. To evaluate the characteristics and frequency of adverse events recorded by the Swedish Medical Products Agency, where herbal medicinal products and natural remedies were suspected as causative agents. Adverse drug reactions reported to the Swedish Medical Product Agency during 2007-15 related to approved herbal medicinal products or natural remedies were included and analysed in the retrospective study. Reports had been assessed for causality when they were lodged and only reports that had been assessed as at least possible were included in the study. In total, 116 reports (concerning 259 adverse reactions) related to herbal medicinal products or natural remedies were found in the Swedish national pharmacovigilance database. The active ingredients most frequently suspected during the study period were black cohosh rhizome (15 reports), purple coneflower herb (14 reports) and a combination of extracts of pollen (13 reports). Adverse reactions related to skin and subcutaneous tissue were the most commonly reported reactions. No previously unknown safety problems have been discovered in the present study. This finding could be explained by a thorough pre-approval assessment of medicinal products and the fact that most herbal preparations in medicinal products have been in clinical use for many years (for traditional herbal medicinal products, the requirements are ≥30 years), i.e. adverse reactions are acknowledged and assessed before approval.

Treatment of Chronic Hepatitis C Virus Infection in Children : A Position Paper by the Hepatology Committee of European Society of Paediatric Gastroenterology, Hepatology and Nutrition

NARCIS (Netherlands)

Indolfi, Giuseppe; Hierro, Loreto; Dezsofi, Antal; Jahnel, Jörg; Debray, Dominique; Hadzic, Nedim; Czubowski, Piotr; Gupte, Girish; Mozer-Glassberg, Yael; van der Woerd, Wendy; Smets, Françoise; Verkade, Henkjan J; Fischler, Björn

Objectives: In 2017, the European Medicines Agency and the Food and Drug Administration approved the use of the fixed-dose combination of ledipasvir/sofosbuvir and of the combination of sofosbuvir and ribavirin for treatment of adolescents (12-17 years or weighing > 35 kg) with chronic hepatitis C

Patients' intention to consume prescribed and non-prescribed medicines: A study based on the theory of planned behaviour in selected European countries.

Science.gov (United States)

Kamekis, A; Bertsias, A; Moschandreas, J; Petelos, E; Papadakaki, M; Tsiantou, V; Saridaki, A; Symvoulakis, E K; Souliotis, K; Papadakis, N; Faresjö, T; Faresjö, A; Martinez, L; Agius, D; Uncu, Y; Sengezer, T; Samoutis, G; Vlcek, J; Abasaeed, A; Merkouris, B; Lionis, C

2018-02-01

Polypharmacy has a significant impact on patients' health with overall expenditure on over-the-counter (OTC) medicines representing a substantial burden in terms of cost of treatment. The aim of this study, which was conducted within the framework of a European Project funded by the European Union under the Seventh Framework Programme and was entitled OTC-SOCIOMED, was to report on possible determinants of patient behaviour regarding the consumption of medicines, and particularly OTCs, in the context of primary care. A multicentre, cross-sectional study was designed and implemented in well-defined primary healthcare settings in Cyprus, the Czech Republic, France, Greece, Malta and Turkey. Patients completed a questionnaire constructed on the basis of the theory of planned behaviour (TPB), which was administered via face-to-face interviews. The percentage of patients who had consumed prescribed medicines over a 6-month period was consistently high, ranging from 79% in the Czech Republic and 82% in Turkey to 97% in Malta and 100% in Cyprus. Reported non-prescribed medicine consumption ranged from 33% in Turkey to 92% in the Czech Republic and 97% in Cyprus. TPB behavioural antecedents explained 43% of the variability of patients' intention to consume medicines in Malta and 24% in Greece, but only 3% in Turkey. Subjective norm was a significant predictor of the intention to consume medicines in all three countries (Greece, Malta and Turkey), whereas attitude towards consumption was a significant predictor of the expectation to consume medicines, if needed. This study shows that parameters such as patients' beliefs and influence from family and friends could be determining factors in explaining the high rates of medicine consumption. Factors that affect patients' behavioural intention towards medicine consumption may assist in the formulation of evidence-based policy proposals and inform initiatives and interventions aimed at increasing the appropriate use of medicines

The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: version 5 - 2018.

Science.gov (United States)

Jassam, Nuthar; Lake, Jennifer; Dabrowska, Milena; Queralto, Jose; Rizos, Demetrios; Lichtinghagen, Ralf; Baum, Hannsjörg; Ceriotti, Ferruccio; O'Mullane, John; Homšak, Evgenija; Charilaou, Charis; Ohlson, Mats; Rako, Ivana; Vitkus, Dalius; Kovac, Gustav; Verschuure, Pauline; Racek, Jaroslav; Chifiriuc, Mariana Carmen; Wieringa, Gilbert

2018-06-05

Although laboratory medicine practise varies across the European Union's (EU) member states, the extent of overlap in scope is such that a common syllabus describing the education and training associated with high-quality, specialist practise can be identified. In turn, such a syllabus can help define the common set of skills, knowledge and competence in a Common Training Framework (CTF) for non-medical Specialists in Laboratory Medicine under EU Directive 2013/55/EU (The recognition of Professional Qualifications). In meeting the requirements of the directive's CTF patient safety is particularly enhanced when specialists seek to capitalise on opportunities for free professional migration across EU borders. In updating the fourth syllabus, the fifth expands on individual discipline requirements, new analytical techniques and use of statistics. An outline structure for a training programme is proposed together with expected responsibilities of trainees and trainers; reference is provided to a trainee's log book. In updating the syllabus, it continues to support national programmes and the aims of EU Directive 2013/55/EU in providing safeguards to professional mobility across European borders at a time when the demand for highly qualified professionals is increasing in the face of a disparity in their distribution across Europe. In support of achieving a CTF, the syllabus represents EFLM's position statement for the education and training that underpins the framework.

VIth EUROPEAN SPORTS MEDICINE CONGRESS October 14-18 2009, Antalya/Turkey

Directory of Open Access Journals (Sweden)

2009-12-01

Full Text Available On behalf of Turkish Sports Medicine Association, we are proud to host 6th. EFSMA European Sports Medicine Congress in Antalya, Turkey; a country founded in Anatolia with a ten thousand year old cultural heritage, acting as a geographic and socio-cultural link between West and East.The choice of Antalya as the venue of our Congress is to provide a unique ambiance with the incomparable historic presence, natural beauty and cultural charm of this part of Anatolia. We hope that this Congress in the land of pioneers of medicine such as Avicenna and Hipocrates inspires and stimulates you. Surrounded by amazing scenery of sharp contrasts, Antalya, Turkey’s principal resort, is an attractive city with shady palm-lined boulevards and a prize-winning marina. Antalya has been continuously inhabited since its founding in 159 BC by Attalos II, a King of Pergamum, who named the city Attaleia after himself.The Romans, Byzantines and Seljuks successively inhabited in Antalya before Ottomans ruled the territory.Today, Antalya is a famous tourism center in Mustafa Kemal Ataturk’s modern Turkish Republic, providing a premium touristic service mainly to Europe.We would like to welcome you to share the recent scientific developments in the area of sports medicine. We believe this Congress provides a high quality scientific environment for the presentation of new research and exchange of information by all disciplines related to sports and medicine.In recent years, the EFSMA has grown and developed into what is now a leading and dynamic force in Sports Medicine in Europe. It is with the same dynamism and expertise that are the hallmarks of a high calibre and carefully arranged scientific programme. A thorough discussion and critical evaluation of the latest advancements in sports medicine are key features of the scientific programme. The sessions, which will include educational courses, state-of-the-art lectures, panel and round table discussions and symposia

The Innovative Medicines Initiative's New Drugs for Bad Bugs programme: European public-private partnerships for the development of new strategies to tackle antibiotic resistance.

Science.gov (United States)

Kostyanev, T; Bonten, M J M; O'Brien, S; Steel, H; Ross, S; François, B; Tacconelli, E; Winterhalter, M; Stavenger, R A; Karlén, A; Harbarth, S; Hackett, J; Jafri, H S; Vuong, C; MacGowan, A; Witschi, A; Angyalosi, G; Elborn, J S; deWinter, R; Goossens, H

2016-02-01

Antibiotic resistance (ABR) is a global public health threat. Despite the emergence of highly resistant organisms and the huge medical need for new drugs, the development of antibacterials has slowed to an unacceptable level worldwide. Numerous government and non-government agencies have called for public-private partnerships and innovative funding mechanisms to address this problem. To respond to this public health crisis, the Innovative Medicines Initiative Joint Undertaking programme has invested more than €660 million, with a goal of matched contributions from the European Commission and the European Federation of Pharmaceutical Industries and Associations, in the development of new antibacterial strategies. The New Drugs for Bad Bugs (ND4BB) programme, an Innovative Medicines Initiative, has the ultimate goal to boost the fight against ABR at every level from basic science and drug discovery, through clinical development to new business models and responsible use of antibiotics. Seven projects have been launched within the ND4BB programme to achieve this goal. Four of them will include clinical trials of new anti-infective compounds, as well as epidemiological studies on an unprecedented scale, which will increase our knowledge of ABR and specific pathogens, and improve the designs of the clinical trials with new investigational drugs. The need for rapid concerted action has driven the funding of seven topics, each of which should add significantly to progress in the fight against ABR. ND4BB unites expertise and provides a platform where the commitment and resources required by all parties are streamlined into a joint public-private partnership initiative of unprecedented scale. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

The EC4 European syllabus for post-graduate training in clinical chemistry and laboratory medicine: version 4--2012.

Science.gov (United States)

Wieringa, Gijsbert; Zerah, Simone; Jansen, Rob; Simundic, Ana-Maria; Queralto, José; Solnica, Bogdan; Gruson, Damien; Tomberg, Karel; Riittinen, Leena; Baum, Hannsjörg; Brochet, Jean-Philippe; Buhagiar, Gerald; Charilaou, Charis; Grigore, Camelia; Johnsen, Anders H; Kappelmayer, Janos; Majkic-Singh, Nada; Nubile, Giuseppe; O'Mullane, John; Opp, Matthias; Pupure, Silvija; Racek, Jaroslav; Reguengo, Henrique; Rizos, Demetrios; Rogic, Dunja; Špaňár, Július; Štrakl, Greta; Szekeres, Thomas; Tzatchev, Kamen; Vitkus, Dalius; Wallemacq, Pierre; Wallinder, Hans

2012-08-01

Laboratory medicine's practitioners across the European community include medical, scientific and pharmacy trained specialists whose contributions to health and healthcare is in the application of diagnostic tests for screening and early detection of disease, differential diagnosis, monitoring, management and treatment of patients, and their prognostic assessment. In submitting a revised common syllabus for post-graduate education and training across the 27 member states an expectation is set for harmonised, high quality, safe practice. In this regard an extended 'Core knowledge, skills and competencies' division embracing all laboratory medicine disciplines is described. For the first time the syllabus identifies the competencies required to meet clinical leadership demands for defining, directing and assuring the efficiency and effectiveness of laboratory services as well as expectations in translating knowledge and skills into ability to practice. In a 'Specialist knowledge' division, the expectations from the individual disciplines of Clinical Chemistry/Immunology, Haematology/Blood Transfusion, Microbiology/ Virology, Genetics and In Vitro Fertilisation are described. Beyond providing a common platform of knowledge, skills and competency, the syllabus supports the aims of the European Commission in providing safeguards to increasing professional mobility across European borders at a time when demand for highly qualified professionals is increasing and the labour force is declining. It continues to act as a guide for the formulation of national programmes supplemented by the needs of individual country priorities.

Nurse prescribing of medicines in Western European and Anglo-Saxon countries: a survey on forces, conditions and jurisdictional control.

Science.gov (United States)

Kroezen, Marieke; Francke, Anneke L; Groenewegen, Peter P; van Dijk, Liset

2012-08-01

The number of Western European and Anglo-Saxon countries where nurses are legally allowed to prescribe medicines is growing. As the prescribing of medicines has traditionally been the task of the medical profession, nurse prescribing is changing the relationship between the medical and nursing professions. To gain more insight into the forces that led to the introduction of nurse prescribing of medicines in Western European and Anglo-Saxon countries, as well as into the legal, educational and organizational conditions under which nurses prescribe in these countries. Moreover, this study sought to determine which consequences nurse prescribing has for the division of jurisdictional control over prescribing between the nursing and medical professions. International survey. An email survey was sent to 60 stakeholders of professional nursing or medical associations or government bodies, at national, state or provincial level across ten Western European and Anglo-Saxon countries, namely Australia, Canada, Finland, Ireland, the Netherlands, New Zealand, Spain, Sweden, the United Kingdom and the United States of America. The survey addressed the reasons for the introduction of nurse prescribing and the conditions under which nurses are or will be prescribing medicines. The response rate was 65% (n=39). It was shown that a diversity of forces led to the introduction of nurse prescribing, and respondents from nursing and medical associations and government bodies cited different forces as being important for the introduction of nurse prescribing. Representatives of nurses' associations oftentimes emphasized the medication needs of patients living in remote geographical areas, while representatives of medical associations more often pointed to workforce shortages within the health care service. The conditions under which nurses prescribe medicines vary considerably, from countries where nurses prescribe independently to countries in which prescribing by nurses is only

Traditional use and safety of herbal medicines

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Davyson de L. Moreira

Full Text Available In the European Union, traditional herbal medicines that are regarded as "acceptably safe, albeit not having a recognized level of efficacy" fit into a special category of drugs ("traditional herbal medicine products" for which requirements of non-clinical and clinical studies are less rigorous. A regulation proposal published by the Brazilian National Health Surveillance (Anvisa defines a similar drug category ("traditional phytotherapeutic products" for registration purposes. Regarding herbal medicines, both agencies seem to be lenient regarding proof of efficacy, and consider long-standing folk use as evidence of safety and a waiver of a thorough toxicological evaluation. Nonetheless, several herbal products and constituents with a long history of folk usage are suspected carcinogenic and/or hepatotoxic. Herbal products have also been shown to inhibit and/or induce drug-metabolizing enzymes. Since herbal medicines are often used in conjunction with conventional drugs, kinetic and clinical interactions are a cause for concern. A demonstration of the safety of herbal medicines for registration purposes should include at least in vitroand in vivogenotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for > 3 months or intermittently for > 6 months, reproductive and developmental toxicity studies (for drugs used by women of childbearing age, and investigation of the effects on drug-metabolizing enzymes.

Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies’ professionals in the European Economic Area

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Włodarczak U

2017-12-01

Full Text Available Background: The Falsified Medicines Directive (FMD is a response of the European Union to the increasing number of falsified medicines present in the legal supply chain within the Member States of the community. Effective implementation of the new regulations will depend on the effective cooperation of all parties involved in the distribution of medicinal products including the managers of pharmaceutical companies. Objective: The objective of the study was to examine awareness of the Implementation of the FMD among pharmaceutical company professionals in the European Economic Area. Methods: Sampling was conducted using a method called purposive sampling. An appropriate research tool in the form of an original questionnaire was made available to the respondents in electronic form. During the period from January 2016 to June 2016, 1,496 e-mail messages were sent. The response rate was 17.37%. Results: The study included 99 women (39.3% and 153 men (60.7%. In the study group, 95.7% of people had heard of FMD. Doctors had rarely heard about the falsified medicine directive when compared to pharmacists (p=0.0063, people working in the pharmaceutical industry (p=0.0014, and respondents with a different professional profile (p=0.0114. In the study group, 89.6% of people were aware of the role of National Medicines Verification Organization in the process of implementing the provisions of FMD into the national system of distribution of medicinal products. The number of the respondents who knew the deadline for the implementation of FMD was significantly higher in the study population, i.e. 91.9% (p=0.0001. Both the younger respondents and those with lower level of education were less aware of the time requirements posed to national regulators (p=0.0003, p=0.0023, respectively. Conclusions: Awareness of the regulations related to the implementation of the FMD, although relatively high among pharmaceutical company professionals in the EEA, is still

Asian School of Nuclear Medicine

International Nuclear Information System (INIS)

Sundram, F.X.

2007-01-01

A number of organisations are involved in the field of nuclear medicine education. These include International Atomic Energy Agency (IAEA), World Federation of Nuclear Medicine and Biology (WFNMB), Asia-Oceania Federation of Nuclear Medicine and Biology (AOFNMB), Society of Nuclear Medicine (SNM in USA), European Association of Nuclear Medicine (EANM). Some Universities also have M.Sc courses in Nuclear Medicine. In the Asian Region, an Asian Regional Cooperative Council for Nuclear Medicine (ARCCNM) was formed in 2000, initiated by China, Japan and Korea, with the main aim of fostering the spread of Nuclear Medicine in Asia. The Asian School of Nuclear Medicine (ASNM) was formed in February 2003, with the ARCCNM as the parent body. The Aims of ASNM are: to foster Education in Nuclear Medicine among the Asian countries, particularly the less developed regions; to promote training of Nuclear Medicine Physicians in cooperation with government agencies, IAEA and universities and societies; to assist in national and regional training courses, award continuing medical education (CME) points and provide regional experts for advanced educational programmes; and to work towards awarding of diplomas or degrees in association with recognised universities by distance learning and practical attachments, with examinations. There are 10 to 12 teaching faculty members from each country comprising of physicists, radio pharmacists as well as nuclear medicine physicians. From this list of potential teaching experts, the Vice-Deans and Dean of ASNM would then decide on the 2 appropriate teaching faculty member for a given assignment or a course in a specific country. The educational scheme could be in conjunction with the ARCCNM or with the local participating countries and their nuclear medicine organisations, or it could be a one-off training course in a given country. This teaching faculty is purely voluntary with no major expenses paid by the ASNM; a token contribution could be

Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.

Science.gov (United States)

Pignatti, Francesco; Ehmann, Falk; Hemmings, Robert; Jonsson, Bertil; Nuebling, Micha; Papaluca-Amati, Marisa; Posch, Martin; Rasi, Guido

2014-03-15

The European Union (EU) legal framework for medical device regulation is currently under revision. The European Commission has proposed a new framework to ensure that medical devices serve the needs and ensure the safety of European citizens, aiming for a framework that is fit for purpose, more transparent, and better adapted to scientific and technological progress. The proposed new framework is described as an evolution of the current regime keeping the same legal approach. An important proposed change is that companion diagnostics will no longer be considered as low risk and subject to self-certification by the manufacturer. According to the new proposal, companion diagnostics will be classified as high individual risk or moderate public health risk (category C) and require conformity assessment by a notified body. It has also been proposed that evidence of the clinical utility of the device for the intended purpose should be required for companion diagnostics. In this article, we review the EU legal framework relevant for companion diagnostics, describe the proposed changes, and summarize the available scientific guidance from the European Medicines Agency and its regulatory experience with cancer drug development including companion diagnostics. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

Catalogue of knowledge and skills for sleep medicine.

Science.gov (United States)

Penzel, Thomas; Pevernagie, Dirk; Dogas, Zoran; Grote, Ludger; de Lacy, Simone; Rodenbeck, Andrea; Bassetti, Claudio; Berg, Søren; Cirignotta, Fabio; d'Ortho, Marie-Pia; Garcia-Borreguero, Diego; Levy, Patrick; Nobili, Lino; Paiva, Teresa; Peigneux, Philippe; Pollmächer, Thomas; Riemann, Dieter; Skene, Debra J; Zucconi, Marco; Espie, Colin

2014-04-01

Sleep medicine is evolving globally into a medical subspeciality in its own right, and in parallel, behavioural sleep medicine and sleep technology are expanding rapidly. Educational programmes are being implemented at different levels in many European countries. However, these programmes would benefit from a common, interdisciplinary curriculum. This 'catalogue of knowledge and skills' for sleep medicine is proposed, therefore, as a template for developing more standardized curricula across Europe. The Board and The Sleep Medicine Committee of the European Sleep Research Society (ESRS) have compiled the catalogue based on textbooks, standard of practice publications, systematic reviews and professional experience, validated subsequently by an online survey completed by 110 delegates specialized in sleep medicine from different European countries. The catalogue comprises 10 chapters covering physiology, pathology, diagnostic and treatment procedures to societal and organizational aspects of sleep medicine. Required levels of knowledge and skills are defined, as is a proposed workload of 60 points according to the European Credit Transfer System (ECTS). The catalogue is intended to be a basis for sleep medicine education, for sleep medicine courses and for sleep medicine examinations, serving not only physicians with a medical speciality degree, but also PhD and MSc health professionals such as clinical psychologists and scientists, technologists and nurses, all of whom may be involved professionally in sleep medicine. In the future, the catalogue will be revised in accordance with advances in the field of sleep medicine. © 2013 European Sleep Research Society.

Cross-Cultural Issues of Intra- and Inter-Organisational Cooperation in Space Operations: A Survey Study with Ground Personnel of the European Space Agency

Science.gov (United States)

Mjeldheim Sandal, Gro; Mjeldheim Sandal, Gro; Manzey, Dietrich

Today's space operations often involve close co-working of people with different ethnical, professional and organizational backgrounds. The aim of the study was to examine the implications of cultural diversity for efficient collaboration within the European Space Agency (ESA), and between ESA employees and representatives from other agencies. Methods: A web-based survey was answered by 905 employees at the European Astronaut Centre and at the European Space Technology Centre. An adapted version of the Flight Management Attitude Questionnaire by Helmreich and Merrit was used. Personnel were also asked about interpersonal and operational issues that interfered with efficient co-working within ESA and in relation to other space agencies. Results: Collaboration within ESA: A descriptive analysis was conducted of the rank orders of challenges perceived by members of different nationalities (the Netherlands (N=68), German (N=138), Italian (N=135), French (N=124), British (N=84) and Scandinavian (27).Rank orders show a surprisingly uniformity across nationalities. Most respondents perceived differences in the preferred leadership style as the main challenge for co-working in multi-national groups followed by differences in dealing with conflicts and misunderstandings. In contrast communication problems due different languages and differences in non-verbal behaviour, as well as differences in gender stereotypes were among the lowest rated issues. However, Scandinavian respondents showed a different pattern from other nationalities. Collaboration between agencies: The most significant issues reported to interfere with the efficiency of inter-agency collaboration varied. Most difficulties were reported in relation to clarity of communication, insufficient sharing of task related information, understanding the process of decision making in partner organization, and authoritarian leadership style in the partner organization Conclusion: Cultural differences in leadership and

Protocol Additional to the agreement between France, the European Atomic Energy Community and the International Atomic Energy Agency for the application of safeguards in France

International Nuclear Information System (INIS)

2005-01-01

The text of the Protocol Additional to the Agreement between France, the European Atomic Energy Community and the International Atomic Energy Agency for the Application of Safeguards in France is reproduced in the Annex to this document for the information of all Members. The Additional Protocol was approved by the Board of Governors on 11 June 1998. It was signed in Vienna on 22 September 1998. Pursuant to Article 16 of the Additional Protocol, the Protocol entered into force on 30 April 2004, the date on which the Agency received written notification that the European Atomic Energy Community and France had met their respective internal requirements for entry into force

Postgraduate education in internal medicine in Europe.

Science.gov (United States)

Cranston, Mark; Slee-Valentijn, Monique; Davidson, Christopher; Lindgren, Stefan; Semple, Colin; Palsson, Runolfur

2013-10-01

Limited information exists on the framework and content of postgraduate education in internal medicine in Europe. This report describes the results of a survey of postgraduate training in internal medicine in the European countries. Two online questionnaire-based surveys were carried out by the European Board of Internal Medicine, one on the practice of internists and the other on postgraduate training in internal medicine. The national internal medicine societies of all 30 member countries of the European Federation of Internal Medicine were invited to participate. The responses were reviewed by internal medicine residents from the respective countries and summaries of the data were sent to the national societies for approval. Descriptive analysis of the data on postgraduate training in internal medicine was performed. Twenty-seven countries (90%) completed the questionnaire and approved their datasets. The length of training ranged from four to six years and was commonly five years. The majority of countries offered training in internal medicine and a subspecialty. A common trunk of internal medicine was frequently a component of subspecialty training programmes. Hospital inpatient service was the predominant setting used for training. A final certifying examination was in place in 14 countries. Although some similarities exists, there appear to be significant differences in the organisation, content and governance of postgraduate training in internal medicine between the European countries. Our findings will prove invaluable for harmonisation of training and qualification in internal medicine in Europe. © 2013.

European Society for Swallowing Disorders – European Union Geriatric Medicine Society white paper: oropharyngeal dysphagia as a geriatric syndrome

Directory of Open Access Journals (Sweden)

Baijens LW

2016-10-01

Full Text Available Laura WJ Baijens,1 Pere Clavé,2,3 Patrick Cras,4 Olle Ekberg,5 Alexandre Forster,6 Gerald F Kolb,7 Jean-Claude Leners,8 Stefano Masiero,9 Jesús Mateos-Nozal,10 Omar Ortega,2,3 David G Smithard,11 Renée Speyer,12 Margaret Walshe13 1Department of Otorhinolaryngology – Head and Neck Surgery, Maastricht University Medical Center, Maastricht, the Netherlands; 2Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital of Mataró, Autonomous University of Barcelona, Mataró, 3CIBERehd, Instituto de Salud Carlos III, Barcelona, Spain; 4Department of Neurology, Antwerp University Hospital, University of Antwerp, Born Bunge Institute, Edegem, Belgium; 5Department of Translational Medicine, Division of Medical Radiology, Skåne University Hospital, Malmö, Sweden; 6Clinique Bois-Bougy, Nyon, Switzerland; 7Department of Geriatrics and Physical Medicine, Bonifatius Hospital, Lingen, Germany; 8Long Term Care and Hospice, Ettelbruck, Luxembourg; 9Rehabilitation Unit, Department of Neuroscience, University of Padua, Padova, Italy; 10Department of Geriatric Medicine, Hospital Ramón y Cajal, Madrid, Spain; 11Clinical Gerontology, Princess Royal University Hospital, King’s College Hospital Foundation Trust, London, UK; 12College of Healthcare Sciences, James Cook University, Townsville, QLD, Australia; 13Department of Clinical Speech and Language Studies, Trinity College Dublin, Dublin, Ireland Abstract: This position document has been developed by the Dysphagia Working Group, a committee of members from the European Society for Swallowing Disorders and the European Union Geriatric Medicine Society, and invited experts. It consists of 12 sections that cover all aspects of clinical management of oropharyngeal dysphagia (OD related to geriatric medicine and discusses prevalence, quality of life, and legal and ethical issues, as well as health economics and social burden. OD constitutes impaired or uncomfortable transit of food or liquids

First Central and Eastern European Workshop on Quality control, patient dosimetry and radiation protection in diagnostic and interventional radiology and nuclear medicine

International Nuclear Information System (INIS)

National Frederic Joliot-Curie Research Institute for Radiobiology and Radiohygiene

2007-01-01

First Central and Eastern European Workshop on Quality Control, Patient Dosimetry and Radiation Protection in Diagnostic and Interventional Radiology and Nuclear Medicine, scientifically supported and accredited as a CPD event for medical physicists by EFOMP, National 'Frederic Joliot-Curie' Research Institute for Radiobiology and Radiohygiene (NRIRR), Budapest, Hungary, April 25-28, 2007. Topics of the meeting included all areas of medical radiation physics except radiation therapy. A unique possibility was realized by inviting four European manufacturers of quality control instrumentation, not only for exhibiting but they also had 45 minutes individual presentations about each manufacturer's product scale and conception. Further sessions dealt with dosimetry, optimization, quality control and testing, radiation protection and standardization, computed tomography and nuclear medicine, in 29 oral presentations and 1 poster of the participants. (S.I.)

Traditional uses of medicinal plants used by Indigenous communities for veterinary practices at Bajaur Agency, Pakistan.

Science.gov (United States)

Aziz, Muhammad Abdul; Khan, Amir Hasan; Adnan, Muhammad; Ullah, Habib

2018-01-29

The pastoral lifestyle of Indigenous communities of Bajaur Agency is bringing them close to natural remedies for treating their domestic animals. Several studies have been conducted across the globe describing the importance of traditional knowledge in veterinary care. Therefore, this study was planned with the aim to record knowledge on ethnoveterinary practices from the remote areas and share sit with other communities through published literature. Data was gathered from community members through semi-structured interviews and analyzed through informant consensus factor (Fic) to evaluate the consent of current ethnoveterinary practices among the local people. In total, 73 medicinal plants were recorded under the ethnoveterinary practices. Most widely used medicinal plants with maximum use reports (URs) were Visnaga daucoides Gaertn., Foeniculum vulgare Mill., Solanum virginianum L., Withania somnifera (L.) Dunal, Glycyrrhiza glabra L., and Curcuma longa L. New medicinal values were found with confidential level of citations for species including Heracleum candicans and Glycerhiza glabra. Family Apiaceae was the utmost family with high number (7 species) of medicinal plants. Maximum number of medicinal plants (32) was used for gastric problems. High Fic was recorded for dermatological (0.97) followed by reproductive (0.93) and gastrointestinal disorders (0.92). The main route of remedies administration was oral. Current study revealed that the study area has sufficient knowledge on ethnoveterinary medicinal plants. This knowledge is in the custody of nomadic grazers, herders, and aged community members. Plants with new medicinal uses need to be validated phytochemically and pharmacologically for the development of new alternative drugs for veterinary purposes.

Standard procedures for adults in accredited sleep medicine centres in Europe

DEFF Research Database (Denmark)

Fischer, Jürgen; Dogas, Zoran; Bassetti, Claudio L

2012-01-01

The present paper describes standardized procedures within clinical sleep medicine. As such, it is a continuation of the previously published European guidelines for the accreditation of sleep medicine centres and European guidelines for the certification of professionals in sleep medicine, aimed...... at creating standards of practice in European sleep medicine. It is also part of a broader action plan of the European Sleep Research Society, including the process of accreditation of sleep medicine centres and certification of sleep medicine experts, as well as publishing the Catalogue of Knowledge...... and Skills for sleep medicine experts (physicians, non-medical health care providers, nurses and technologists), which will be a basis for the development of relevant educational curricula. In the current paper, the standard operational procedures sleep medicine centres regarding the diagnostic...

Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA.

Science.gov (United States)

Kondo, Hideyuki; Shibatsuji, Masayoshi; Yasuda, Naoyuki

2018-01-01

Micro-, small-, and medium-sized enterprises (SMEs) have been considered as key players who can bring innovative medicinal products and/or technologies into the field. However, they may need much regulatory/scientific supports to provide their products, technologies, or services to the market in a timely way. Both the Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), regulatory authorities for medicinal products in Japan and the EU, respectively, have prepared supportive measures for SMEs from the early phase of product/technology development to the postmarketing phase. With respect to supports for SMEs, both agencies have provided similar SME-specific supportive activities, including routine administrative assistance, consultations about product development strategy from an early phase, as well as specific regulatory/scientific issues and fee incentives. In addition, there is a system to register SME status in the EU, which can be a tool for regulators to know how much potential SME-driven activities have and with whom they should communicate to provide necessary supports. Furthermore, as new technologies and novel products from SMEs are not limited to the region where they are developed, close communication about these topics between the PMDA and the EMA will contribute to advancing patients' access to necessary medicinal products.

Recommendations for the use of tolvaptan in autosomal dominant polycystic kidney disease : a position statement on behalf of the ERA-EDTA Working Groups on Inherited Kidney Disorders and European Renal Best Practice

NARCIS (Netherlands)

Gansevoort, Ron T; Arici, Mustafa; Benzing, Thomas; Birn, Henrik; Capasso, Giovambattista; Covic, Adrian; Devuyst, Olivier; Drechsler, Christiane; Eckardt, Kai-Uwe; Emma, Francesco; Knebelmann, Bertrand; Le Meur, Yannick; Massy, Ziad A; Ong, Albert C M; Ortiz, Alberto; Schaefer, Franz; Torra, Roser; Vanholder, Raymond; Więcek, Andrzej; Zoccali, Carmine; Van Biesen, Wim

Recently, the European Medicines Agency approved the use of the vasopressin V2 receptor antagonist tolvaptan to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adult patients with chronic kidney disease stages 1-3 at

Precision medicine in allergic disease-food allergy, drug allergy, and anaphylaxis-PRACTALL document of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma and Immunology

DEFF Research Database (Denmark)

Muraro, A; Lemanske, Robert F; Castells, M

2017-01-01

This consensus document summarizes the current knowledge on the potential for precision medicine in food allergy, drug allergy, and anaphylaxis under the auspices of the PRACTALL collaboration platform. PRACTALL is a joint effort of the European Academy of Allergy and Clinical Immunology and the ......This consensus document summarizes the current knowledge on the potential for precision medicine in food allergy, drug allergy, and anaphylaxis under the auspices of the PRACTALL collaboration platform. PRACTALL is a joint effort of the European Academy of Allergy and Clinical Immunology...... and the American Academy of Allergy, Asthma and Immunology, which aims to synchronize the European and American approaches to allergy care. Precision medicine is an emerging approach for disease treatment based on disease endotypes, which are phenotypic subclasses associated with specific mechanisms underlying...

U.S. Geological Survey distribution of European Space Agency's Sentinel-2 data

Science.gov (United States)

Pieschke, Renee L.

2017-03-31

A partnership established between the European Space Agency (ESA) and the U.S. Geological Survey (USGS) allows for USGS storage and redistribution of images acquired by the MultiSpectral Instrument (MSI) on the European Union's Sentinel-2 satellite mission. The MSI data are acquired from a pair of satellites, Sentinel-2A and Sentinel-2B, which are part of a larger set of ESA missions focusing on different aspects of Earth observation. The primary purpose of the Sentinel-2 series is to collect multispectral imagery over the Earth’s land surfaces, large islands, and inland and coastal waters. Sentinel-2A was launched in 2015 and Sentinel-2B launched in 2017.The collaborative effort between ESA and USGS provides for public access and redistribution of global acquisitions of Sentinel-2 data at no cost, which allows users to download the MSI imagery from USGS access systems such as Earth- Explorer, in addition to the ESA Sentinels Scientific Data Hub. The MSI sensor acquires 13 spectral bands that are highly complementary to data acquired by the USGS Landsat 8 Operational Land Imager (OLI) and Landsat 7 Enhanced Thematic Mapper Plus (ETM+). The product options from USGS include a Full-Resolution Browse (FRB) image product generated by USGS, along with a 100-kilometer (km) by 100-km tile-based Level-1C top-of-atmosphere (TOA) reflectance product that is very similar (but not identical) to the currently (2017) distributed ESA Level 1C product.

Tramadol can selectively manage moderate pain in children following European advice limiting codeine use.

Science.gov (United States)

Marzuillo, Pierluigi; Calligaris, Lorenzo; Barbi, Egidio

2014-11-01

The European Medicine Agency recommendations limiting codeine use in children have created a void in managing moderate pain. We review the evidence on the pharmacokinetic, pharmacodynamic and safety profile of tramadol, a possible substitute for codeine. Tramadol appears to be safe in both paediatric inpatients and outpatients. It may be appropriate to limit the current use of tramadol to monitored settings in children with risk factors for respiratory depression, subject to further safety evidence. ©2014 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

Legal barriers in accessing opioid medicines: results of the ATOME quick scan of national legislation of eastern European countries.

Science.gov (United States)

Vranken, Marjolein J M; Mantel-Teeuwisse, Aukje K; Jünger, Saskia; Radbruch, Lukas; Lisman, John; Scholten, Willem; Payne, Sheila; Lynch, Tom; Schutjens, Marie-Hélène D B

2014-12-01

Overregulation of controlled medicines is one of the factors contributing to limited access to opioid medicines. The purpose of this study was to identify legal barriers to access to opioid medicines in 12 Eastern European countries participating in the Access to Opioid Medication in Europa project, using a quick scan method. A quick scan method to identify legal barriers was developed focusing on eight different categories of barriers. Key experts in 12 European countries were requested to send relevant legislation. Legislation was quick scanned using World Health Organization guidelines. Overly restrictive provisions and provisions that contain stigmatizing language and incorrect definitions were identified. The selected provisions were scored into two categories: 1) barrier and 2) uncertain, and reviewed by two authors. A barrier was recorded if both authors agreed the selected provision to be a barrier (Category 1). National legislation was obtained from 11 of 12 countries. All 11 countries showed legal barriers in the areas of prescribing (most frequently observed barrier). Ten countries showed barriers in the areas of dispensing and showed stigmatizing language and incorrect use of definitions in their legislation. Most barriers were identified in the legislation of Bulgaria, Greece, Lithuania, Serbia, and Slovenia. The Cypriot legislation showed the fewest total number of barriers. The selected countries have in common as main barriers prescribing and dispensing restrictions, the use of stigmatizing language, and incorrect use of definitions. The practical impact of these barriers identified using a quick scan method needs to be validated by other means. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Opinions and potential solutions regarding dissemination bias from funding agencies of biomedical research in Europe.

Science.gov (United States)

Pardo-Hernandez, Hector; Urrútia, Gerard; Meerpohl, Joerg J; Marušić, Ana; Wager, Elizabeth; Bonfill, Xavier

2018-02-01

Several studies have found that about half of research results from clinical trials are never published. Until now, there has been little information on the views that funding agencies of biomedical research in Europe have regarding this issue and its possible solutions. An electronic survey was conducted among funding agencies from 34 European countries. Participants were asked about their opinions, policies, and potential solutions regarding dissemination bias. On the basis of the results of this survey and the input of the OPEN Consortium and of representatives of stakeholder groups in the knowledge generation process, we formulated recommendations for funding agencies to reduce dissemination bias. We received responses from 64 funding agencies of biomedical medicine from most European countries, out of 245 that were contacted (26%). Of these, 56 funded research at the national and/or international level and were therefore eligible to participate. Policies encouraging publication increased over time: 33 (58.9%) of agencies enforced them in 2005 compared to 38 (67.6%) in 2012. However, only 13 (23.2%) had knowledge of the publications related to research funded in 2005, 23 (41.1%) were able to provide only an estimate, and 20 (35.7%) did not know at all. Regarding recommendations to control dissemination bias, we propose that funding agencies request the dissemination of research results irrespective of the direction of findings. We also call for measures that allow evaluating funded projects past the contractual period and until dissemination of results. Funding agencies should create publicly accessible databases with information on funded projects and dissemination efforts. Despite having policies to encourage publication of results, most funding agencies fail to implement such measures or to ensure compliance. We propose recommendations that could be incorporated in the blueprint of calls for proposals and contracts agreed upon by funding agencies and grant

CSAIO – a progressive tool at the service of staff associations of international organizations and European agencies

CERN Multimedia

Staff Association

2016-01-01

Every year in autumn, a two-day CSAIO (Conference of Staff Associations of International Organizations) conference is organized for staff associations of international organizations based mainly in Europe, as well as European agencies. Creation, objectives and progress CSAIO, created by the staff associations of CERN and OECD in 2000, invites about 30 staff associations to share their experiences and ideas to better identify the expectations and aspirations of a personnel evolving at the heart of international and European organizations. Over time, the preparation of the conference has evolved to better accommodate the requests of the staff representatives coming from different horizons. For two years, there has been an initiative to institutionalize the informal follow-up, during the first half-day of the conference, of themes discussed the previous year. This follow-up allows participants to share their experience on the implementation and impacts of certain propositions as reflected in their organizations ...

New developments in education and training in sexual medicine.

Science.gov (United States)

Reisman, Yacov; Eardley, Ian; Porst, Hartmut

2013-04-01

INTRODUCTION.: The past 12 months have been historic ones for the field of Sexual Medicine in that we have seen the creation of the European Board examination in Sexual Medicine with the title of "Fellow of the European Committee on Sexual Medicine" (FECSM) offered to successful candidates. AIM.: The study aims to promote a high standard of care in Sexual Medicine. METHODS.: An important way of promoting high standards of care is by the development of training, regulation, and assessment framework. The background to these developments and the recent educational activities of the European Society for Sexual Medicine (ESSM) are described in this article. RESULTS.: The creation of the Multidisciplinary Joint Committee on Sexual Medicine (MJCSM) under the auspices of the European Union of Medical Specialists, with the primary purpose to develop the highest possible standards of training in Sexual Medicine in Europe, made it possible to create a process for qualification in Sexual Medicine. The ESSM educational activities created opportunities to support trainees in Sexual Medicine and the first MJCSM exam was held in Amsterdam with a high overall success rate. CONCLUSION.: These activities are intended to improve quality. The FECSM examination is the first of its type and provides a real opportunity for Sexual Medicine physicians to demonstrate and document their knowledge. © 2013 International Society for Sexual Medicine.

Payload operations management of a planned European SL-Mission employing establishments of ESA and national agencies

Science.gov (United States)

Joensson, Rolf; Mueller, Karl L.

1994-01-01

Spacelab (SL)-missions with Payload Operations (P/L OPS) from Europe involve numerous space agencies, various ground infrastructure systems and national user organizations. An effective management structure must bring together different entities, facilities and people, but at the same time keep interfaces, costs and schedule under strict control. This paper outlines the management concept for P/L OPS of a planned European SL-mission. The proposal draws on the relevant experience in Europe, which was acquired via the ESA/NASA mission SL-1, by the execution of two German SL-missions and by the involvement in, or the support of, several NASA-missions.

Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.

Science.gov (United States)

Liberti, Lawrence; Stolk, Pieter; McAuslane, James Neil; Schellens, Jan; Breckenridge, Alasdair M; Leufkens, Hubert

2015-06-01

Guidance and exploratory evidence indicate that the type of endpoints and the magnitude of their outcome can define a therapy's clinical activity; however, little empirical evidence relates specific endpoint properties with regulatory outcomes. We explored the relationship of 3 endpoint properties to regulatory outcomes by assessing 50 oncology marketing authorization applications (MAAs; reviewed from 2009 to 2013). Overall, 16 (32%) had a negative outcome. The most commonly used hard endpoints were overall survival (OS) and the duration of response or stable disease. OS was a component of 91% approved and 63% failed MAAs. The most commonly used surrogate endpoints were progression-free survival (PFS), response rate, and health-related quality of life assessments. There was no difference (p = .3801) between the approved and failed MAA cohorts in the proportion of hard endpoints used. A mean of slightly more than four surrogate endpoints were used per approved MAA compared with slightly more than two for failed MAAs. Longer OS and PFS duration outcomes were generally associated with approvals, often when not statistically significant. The approved cohort was associated with a preponderance of statistically significant (p < .05) improvements in primary endpoints (p < .0001 difference between the approved and failed groups). Three key endpoint properties (type of endpoint [hard/surrogate], magnitude of an endpoint outcome, and its statistical significance) are consistent with the European Medicines Agency guidance and, notwithstanding the contribution of unique disease-specific circumstances, are associated with a predictable positive outcome for oncology MAAs. Regulatory decisions made by the European Medicines Agency determine which new medicines will be available to European prescribers and for which therapeutic indications. Regulatory success or failure can be influenced by many factors. This study assessed three key properties of endpoints used in

Advocating vaccination of adults aged 60 years and older in Western Europe: statement by the Joint Vaccine Working Group of the European Union Geriatric Medicine Society and the International Association of Gerontology and Geriatrics-European Region.

Science.gov (United States)

Michel, Jean-Pierre; Chidiac, Christian; Grubeck-Loebenstein, Beatrix; Johnson, Robert W; Lambert, Paul Henri; Maggi, Stefania; Moulias, Robert; Nicholson, Karl; Werner, Hans

2009-04-01

Vaccines are an underused public health strategy for healthy aging. Considering the risks of vaccine-preventable diseases and the current low vaccine coverage rates in older European citizens, the two European geriatric and gerontological societies (European Union Geriatric Medicine Society [EUGMS] and International Association of Gerontology and Geriatrics-European Region [IAGG-ER]) convened a Joint Vaccine Working Group to develop a consensus document advocating routine vaccination of aging populations. The mandate of this Working Group was to improve the uptake of routine vaccinations in adults aged 60 years and over. The consensus statement underlines the need to establish, strengthen, and harmonize European policies that continue routine vaccinations to adulthood and that will include older populations. Improved vaccination rates will promote healthy aging by reducing the burden of vaccine-preventable infectious diseases in older populations, a population that is rapidly increasing in Europe.

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006

DEFF Research Database (Denmark)

Berendt, Louise; Hakansson, Cecilia; Bach, Karin Ursula Friis

2008-01-01

To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark.......To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark....

UK medicines regulation: responding to current challenges.

Science.gov (United States)

Richards, Natalie; Hudson, Ian

2016-12-01

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. © 2016 The British Pharmacological Society.

9th annual European Antibody Congress, November 11-13, 2013, Geneva, Switzerland.

Science.gov (United States)

Reichert, Janice M; Beck, Alain; Lugovskoy, Alexey A; Wurch, Thierry; Coats, Steven; Brezski, Randall J

2014-01-01

The annual European Antibody Congress (EAC) has traditionally been the key event for updates on critical scientific advances in the antibody field, and 2013 was no exception. Organized by Terrapinn, the well-attended meeting featured presentations on considerations for developing antibodies and antibody-like therapeutics, with separate tracks for antibody-drug conjugates, naked antibodies, and multispecific antibodies or protein scaffolds. The overall focus of the EAC was current approaches to enhance the functionality of therapeutic antibodies or other targeted proteins, with the ultimate goal being improvement of the safety and efficacy of the molecules as treatments for cancer, immune-mediated disorders and other diseases. Roundtable discussion sessions gave participants opportunities to engage in group discussions with industry leaders from companies such as Genmab, Glenmark Pharmaceuticals, MedImmune, Merrimack Pharmaceuticals, and Pierre Fabre. As the 2013 EAC was co-located with the World Biosimilar Congress, participants also received an update on European Medicines Agency guidelines and thoughts on the future direction and development of biosimilar antibodies in the European Union.

The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe

DEFF Research Database (Denmark)

Cornes, Michael P; Church, Stephen; van Dongen-Lases, Edmée

2016-01-01

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 Labor......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...... 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...

Herbal medicinal products versus botanical-food supplements in the European market: state of art and perspectives.

Science.gov (United States)

Bilia, Anna Rita

2015-01-01

Botanical products marketed in Europe are diverse, classified as herbal medicinal products, dietary supplements, cosmetics, foods and beverages depending on the relevant applicable legislation. Many factors are taken into account in the classification of a botanical product (e.g. intended use, labeling, preparations and dosages) according to how it is placed on the market. Herbal medicinal products (HMPs) can only be sold in pharmacies, under the supervision of a pharmacist, and are marketed after full or simplified registration procedures according to their classification, i.e. as over-the-counter drugs (OTC) available without special restrictions and prescription only medicine (POM), which must be prescribed by a licensed medical practitioner. The dietary supplement segment is also sold in the market in dose form (such as capsules, tablets, ampoules of liquids, drops etc) and represents 15-20% of the botanical market at the European level with high variability among each country (i.e. in Italy it reaches up to 80%). In many cases the distinction between medicinal products and food supplements has generated borderline botanical-sourced products, which generally produce confusion and mislead the consumers. As a consequence, there is an urgent need of consumer education and in addition to collect comprehensive data and make this database systematically available to herbalists, nutritionists and medical specialists for a proper classification and harmonization of the use of botanical ingredients, and, as consequence, a correct use of these products.

European Council of Legal Medicine (ECLM) accreditation of forensic pathology services in Europe.

Science.gov (United States)

Mangin, P; Bonbled, F; Väli, M; Luna, A; Bajanowski, T; Hougen, H P; Ludes, B; Ferrara, D; Cusack, D; Keller, E; Vieira, N

2015-03-01

Forensic experts play a major role in the legal process as they offer professional expert opinion and evidence within the criminal justice system adjudicating on the innocence or alleged guilt of an accused person. In this respect, medico-legal examination is an essential part of the investigation process, determining in a scientific way the cause(s) and manner of unexpected and/or unnatural death or bringing clinical evidence in case of physical, psychological, or sexual abuse in living people. From a legal perspective, these types of investigation must meet international standards, i.e., it should be independent, effective, and prompt. Ideally, the investigations should be conducted by board-certified experts in forensic medicine, endowed with a solid experience in this field, without any hierarchical relationship with the prosecuting authorities and having access to appropriate facilities in order to provide forensic reports of high quality. In this respect, there is a need for any private or public national or international authority including non-governmental organizations seeking experts qualified in forensic medicine to have at disposal a list of specialists working in accordance with high standards of professional performance within forensic pathology services that have been successfully submitted to an official accreditation/certification process using valid and acceptable criteria. To reach this goal, the National Association of Medical Examiners (NAME) has elaborated an accreditation/certification checklist which should be served as decision-making support to assist inspectors appointed to evaluate applicants. In the same spirit than NAME Accreditation Standards, European Council of Legal Medicine (ECLM) board decided to set up an ad hoc working group with the mission to elaborate an accreditation/certification procedure similar to the NAME's one but taking into account the realities of forensic medicine practices in Europe and restricted to post

Treatment decision-making for advanced non-small cell lung cancer and differences among European countries: 1st AIOT-ETOP meeting.

Science.gov (United States)

Gridelli, Cesare; Stahel, Rolf; Besse, Benjamin; Ciardiello, Fortunato; Felip, Enriqueta; Gasparini, Stefano; Graziano, Paolo; Rossi, Antonio; de Marinis, Filippo

2011-12-01

The Italian Association of Thoracic Oncology (AIOT) and the European Thoracic Oncology Platform (ETOP) realized the first conjunct educational meeting, open to European oncologists involved in the treatment of thoracic malignancies, entitled "Advanced non-small cell lung cancer: new perspectives in first-line setting". The educational meeting included 8 interactive talks, held by European key opinion leaders, and 5 related clinical cases in which the attendees, divided in working tables based on their country origin, were involved for interactive discussion. The aim of this course was to elucidate the differences or similarities among the European countries in the first-line treatment of patients affected by advanced non-small cell lung cancer (NSCLC). Twenty-two attendees of the following countries participated: Austria, France, Italy, Spain, Swiss, and UK. As expected, some discrepancies between the groups were identified concerning the approach to the diagnostic phase, the choice of first-line regimen, the duration of treatment and the use of maintenance therapy. These discrepancies were mainly due to familiarity with specific therapies and lack of access to certain therapies due to local regulatory issues. The European Medicine Agency grants marketing of drugs in all Europe, regulatory agency of each country can register the drug, but can also deny public reimbursement thus restricting the options of the oncologist. The European Oncology Associations should join to their effort to achieve a uniform access to the cancer therapy for all patients in Europe. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

The univocal identification and safe dispensation of medicinal products across Europe – challenges and solution proposal

Directory of Open Access Journals (Sweden)

Stroetmann, Karl A.

2017-12-01

Full Text Available Problem: The Smart Open Services for European Patients (epSOS the exchange of electronic Patient Summaries and ePrescriptions between selected member states of the European Union (EU. This project basically solved the ‘communication’ or message transfer problem. However, it encountered a serious ‘delivery’ problem: the safe dispensation of a medicinal product noted in a prescription from a given country by a retail pharmacist in another country. The reason for this was that the specified medicine could in many instances not univocally be identified – the same name may identify a product with a different active ingredient, or the product with identical composition may carry a different name in the other country. If the prescribed medicine had not been authorised for marketing in the other country, information on its attributes may not be available. This rendered dispensation by the pharmacist impossible, even where substitution would, in principle, be allowed and possible.Objectives: This paper reports on the goal, activities and achievements of the openMedicine project towards development of a digital solution and its implementation to meet this identification and the resulting delivery challenge. European-wide and cross-Atlantic endeavours to enhance pharmacovigilance by being able to match adverse event reports filed under different drug names which provide, however, for the same active ingredient(s were developed upon. And the need for and benefits of being able to trace for clinical purposes, e.g. the longer-term treatment with the same active ingredient, even when the name of the prescribed medicine changed several times, were explored.Methodological approach: The openMedicine project was funded by the European Commission (EC on behalf of member states to analyse this European-wide problem. Work benefitted from the epSOS project and work by the European Medicines Agency (EMA, the USA Federal Drug Agency (FDA, and standard

ENABLE 2017, the First EUROPEAN PhD and Post-Doc Symposium. Session 4: From Discovery to Cure: The Future of Therapeutics.

Science.gov (United States)

Di Mauro, Gianmarco; Dondi, Ambra; Giangreco, Giovanni; Hogrebe, Alexander; Louer, Elja; Magistrati, Elisa; Mullari, Meeli; Turon, Gemma; Verdurmen, Wouter; Xicoy Cortada, Helena; Zivanovic, Sanja

2018-05-28

The EUROPEAN ACADEMY FOR BIOMEDICAL SCIENCE (ENABLE) is an initiative funded by the European Union Horizon 2020 program involving four renowned European Research Institutes (Institute for Research in Biomedicine-IRB Barcelona, Spain; Radboud Institute for Molecular Life Sciences-RIMLS, the Netherlands; Novo Nordisk Foundation Center for Protein Research-NNF CPR, Denmark; European School of Molecular Medicine-SEMM, Italy) and an innovative science communication agency (Scienseed). With the aim of promoting biomedical science of excellence in Europe, ENABLE organizes an annual three-day international event. This gathering includes a top-level scientific symposium bringing together leading scientists, PhD students, and post-doctoral fellows; career development activities supporting the progression of young researchers and fostering discussion about opportunities beyond the bench; and outreach activities stimulating the interaction between science and society. The first European PhD and Postdoc Symposium, entitled "Breaking Down Complexity: Innovative Models and Techniques in Biomedicine", was hosted by the vibrant city of Barcelona. The scientific program of the conference was focused on the most recent advances and applications of modern techniques and models in biomedical research and covered a wide range of topics, from synthetic biology to translational medicine. Overall, the event was a great success, with more than 200 attendees from all over Europe actively participating in the symposium by presenting their research and exchanging ideas with their peers and world-renowned scientists.

The practice of internal medicine in Europe: organisation, clinical conditions and procedures.

Science.gov (United States)

Cranston, Mark; Semple, Colin; Duckitt, Roger; Vardi, Moshe; Lindgren, Stefan; Davidson, Christopher; Palsson, Runolfur

2013-10-01

Current information on the role of internists in the European countries is scarce. This report describes the results of a survey of the practice of internists in Europe. Two online questionnaire-based surveys were carried out by the European Board of Internal Medicine, one on the practice of internists and the other on postgraduate training in internal medicine. The national internal medicine societies of all 30 member countries of the European Federation of Internal Medicine were invited to participate. The responses were reviewed by internal medicine trainees from the respective countries and summaries of the data were sent to the national societies for approval. Descriptive analysis of the data on the practice of internists was carried out. Twenty-seven countries (90%) completed the questionnaire and approved their datasets. In 8 European countries, most internists practised internal medicine alone and in 7 countries at least half of physicians practised internal medicine together with a subspecialty. Internal medicine was considered a hospital-based specialty in most countries. The majority of selected presenting problems and diagnoses were rated as commonly encountered in all countries. More variability between countries was observed in the performance of diagnostic and therapeutic procedures. Many similarities exist in the practice of internal medicine between the European countries, while some differences are present that likely reflect the variable impact of subspecialisation. The results of the survey should prove valuable for the definition of specific competencies and development of a common curriculum for internal medicine at the European level. © 2013.

Highlights of the Annual Congress of the European Association of Nuclear Medicine, Istanbul, 2005: the incremental value of nuclear medicine for patient management and care

Energy Technology Data Exchange (ETDEWEB)

Cuocolo, Alberto; Acampa, Wanda; Varrone, Andrea; Salvatore, Marco [University of Naples Federico II, Department of Biomorphological and Functional Sciences, Napoli (Italy); Institute of Biostructures and Bioimages of the National Council of Research, Naples (Italy)

2006-03-15

The 2005 Annual Congress of the European Association of Nuclear Medicine (EANM) took place in Istanbul on October 15-19, under the chairmanship of Professor Hatice Durak. The programme was of excellent quality and represented a further step towards the achievement of a standardized EANM congress structure. A large industrial exhibition demonstrated the latest technological innovations and developments within the field. The congress was a great success: there were more than 4,000 participants, and 1,670 abstracts were received. Of these, 1,399 were accepted for oral or poster presentations, with a rejection rate of 16.2%. The original investigations presented were related to different areas of nuclear medicine, and addressed particularly advances in instrumentation and data processing, progress in radiochemistry and pharmacy, novel diagnostics and therapeutics, and new insights in well-established areas of clinical application, such as oncology, cardiology, neurology, psychiatry, endocrinology, paediatrics, nephrology, and infection and inflammation. It is noteworthy that a number of studies presented at this congress focussed on the quantitative interpretation of the imaging data and on pragmatic endpoints, such as adverse outcomes, and identified when nuclear medicine procedures achieved clinical effectiveness for patient care and management. These and many other studies presented at the congress demonstrate once more the crucial role that nuclear medicine has to play in contemporary medicine. This highlights lecture is only a brief summary of the large amount of data presented and discussed, which can be found in much greater detail in the congress proceedings book, published as volume 32, supplement 1 of the Eur J Nucl Med Mol Imaging in September 2005. (orig.)

Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

DEFF Research Database (Denmark)

Schulman, S; Angerås, U; Bergqvist, D

2010-01-01

subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used......The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its...... in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials...

European Association of Nuclear Medicine congress. Abstracts

International Nuclear Information System (INIS)

Anon.

1997-01-01

To assess the exact place of nuclear medicine studies in the clinical environment in consensus with clinicians and radiologists will probably be our most important task during the coming year. Our society cannot afford unnecessary duplication of diagnostic tests but neither should our patients suffer from the failure to use procedures which could change the outcome of their illness or avoid unnecessary pain and costs because of ignorance, or even worse, self defence by larger and thus stronger pressure groups. Defeatism is as inappropriate as remaining in the splendid isolation of our professional and scientific organisations. There is no place for excessive humbleness either, most of the unnecessary procedures performed in modern medicine lie within the domain of other specialists. It is our duty to participate as actors in the thorough reappraisal of the medical, social and economic context of our activity in the interst of our field and our patients. By confronting our ideas and knowledge with those of others, by using our inventiveness to transfer important results from research laboratories to clinical practice and vice versa, by concentrating on the essential rather than pursuing all possible directions, we will be able to influence positively the future of nuclear medicine. There is no better way to develop our speciality than by understanding the clinical issues, by being able to communicate with our clinical partners and by performing common studies on the clinical impact, cost-efficiency and cost-benefit of nuclear medicine procedures. (orig./AJ)

Undergraduate teaching of occupational medicine in European schools of medicine

NARCIS (Netherlands)

Gehanno, J. F.; Bulat, P.; Martinez-Jarreta, B.; Pauncu, E. A.; Popescu, F.; Smits, P. B. A.; van Dijk, F. J. H.; Braeckman, L.

2014-01-01

General practitioners play or should play a role in occupational medicine (OM), either in diagnosing occupational diseases or in counseling on return to work. Nevertheless, their training has been reported to be insufficient in most single country studies. The objectives of this study were to

Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod

Science.gov (United States)

Correale, Jorge; Chiquete, Erwin; Boyko, Alexey; Beran, Roy G; Strauch, Jorge Barahona; Milojevic, Snezana; Frider, Nadina

2016-01-01

Both proprietary and nonproprietary medicines are expected to undergo rigorous preapproval testing and both should meet stringent health authority regulatory requirements related to quality to obtain approval. Nonproprietary (also known as copy, or generic) medicines, which base their authorization and use on the proprietary documentation and label, are often viewed as a means to help lower the cost and, thus, increase patient access. If these medicines fail to meet quality standards, such as good manufacturing practice and bioequivalence (in humans), they are then defined as substandard copies and can pose serious risks to patients in terms of safety and efficacy. Potentially noncontrolled or different manufacturing process and excipients in nonproprietary medicines may result in poor batch-to-batch reproducibility (accurate and consistent quantity of each ingredient in each capsule/tablet) and lower quality. Substandard, nonproprietary copies of medicines that are immunomodulatory or immunosuppressive are of concern to patients due to their possible untoward safety and lack of efficacy events. This article reviews the potential risks associated with nonproprietary medicines that do not meet the regulatory requirements of the United States Food and Drug Administration, the European Medicines Agency, or the World Health Organization. The clinical implications for patients are described. This article focuses on nonproprietary medicines for multiple sclerosis, particularly fingolimod, that are not identical to proprietary versions and could thus fail to meet efficacy expectations or have different impact on the safety of patients with multiple sclerosis. PMID:27418809

Radiation doses for pediatric nuclear medicine studies: comparing the North American consensus guidelines and the pediatric dosage card of the European Association of Nuclear Medicine.

Science.gov (United States)

Grant, Frederick D; Gelfand, Michael J; Drubach, Laura A; Treves, S Ted; Fahey, Frederic H

2015-04-01

Estimated radiation dose is important for assessing and communicating the risks and benefits of pediatric nuclear medicine studies. Radiation dose depends on the radiopharmaceutical, the administered activity, and patient factors such as age and size. Most radiation dose estimates for pediatric nuclear medicine have not been based on administered activities of radiopharmaceuticals recommended by established practice guidelines. The dosage card of the European Association of Nuclear Medicine (EANM) and the North American consensus guidelines each provide recommendations of administered activities of radiopharmaceuticals in children, but there are substantial differences between these two guidelines. For 12 commonly performed pediatric nuclear medicine studies, two established pediatric radiopharmaceutical administration guidelines were used to calculate updated radiation dose estimates and to compare the radiation exposure resulting from the recommendations of each of the guidelines. Estimated radiation doses were calculated for 12 common procedures in pediatric nuclear medicine using administered activities recommended by the dosage card of the EANM (version 1.5.2008) and the 2010 North American consensus guidelines for radiopharmaceutical administered activities in pediatrics. Based on standard models and nominal age-based weights, radiation dose was estimated for typical patients at ages 1, 5, 10 and 15 years and adult. The resulting effective doses were compared, with differences greater than 20% considered significant. Following either the EANM dosage card or the 2010 North American guidelines, the highest effective doses occur with radiopharmaceuticals labeled with fluorine-18 and iodine-123. In 24% of cases, following the North American consensus guidelines would result in a substantially higher radiation dose. The guidelines of the EANM dosage card would lead to a substantially higher radiation dose in 39% of all cases, and in 62% of cases in which patients

Radiation doses for pediatric nuclear medicine studies: comparing the North American consensus guidelines and the pediatric dosage card of the European Association of Nuclear Medicine

International Nuclear Information System (INIS)

Grant, Frederick D.; Drubach, Laura A.; Treves, S. Ted; Fahey, Frederic H.; Gelfand, Michael J.

2015-01-01

Estimated radiation dose is important for assessing and communicating the risks and benefits of pediatric nuclear medicine studies. Radiation dose depends on the radiopharmaceutical, the administered activity, and patient factors such as age and size. Most radiation dose estimates for pediatric nuclear medicine have not been based on administered activities of radiopharmaceuticals recommended by established practice guidelines. The dosage card of the European Association of Nuclear Medicine (EANM) and the North American consensus guidelines each provide recommendations of administered activities of radiopharmaceuticals in children, but there are substantial differences between these two guidelines. For 12 commonly performed pediatric nuclear medicine studies, two established pediatric radiopharmaceutical administration guidelines were used to calculate updated radiation dose estimates and to compare the radiation exposure resulting from the recommendations of each of the guidelines. Estimated radiation doses were calculated for 12 common procedures in pediatric nuclear medicine using administered activities recommended by the dosage card of the EANM (version 1.5.2008) and the 2010 North American consensus guidelines for radiopharmaceutical administered activities in pediatrics. Based on standard models and nominal age-based weights, radiation dose was estimated for typical patients at ages 1, 5, 10 and 15 years and adult. The resulting effective doses were compared, with differences greater than 20% considered significant. Following either the EANM dosage card or the 2010 North American guidelines, the highest effective doses occur with radiopharmaceuticals labeled with fluorine-18 and iodine-123. In 24% of cases, following the North American consensus guidelines would result in a substantially higher radiation dose. The guidelines of the EANM dosage card would lead to a substantially higher radiation dose in 39% of all cases, and in 62% of cases in which patients

Systematic review on the evaluation criteria of orphan medicines in Central and Eastern European countries.

Science.gov (United States)

Zelei, Tamás; Molnár, Mária J; Szegedi, Márta; Kaló, Zoltán

2016-06-04

In case of orphan drugs applicability of the standard health technology assessment (HTA) process is limited due to scarcity of good clinical and health economic evidence. Financing these premium priced drugs is more controversial in the Central and Eastern European (CEE) region where the public funding resources are more restricted, and health economic justification should be an even more important aspect of policy decisions than in higher income European countries. To explore and summarize the recent scientific evidence on value drivers related to the health technology assessment of ODs with a special focus on the perspective of third party payers in CEE countries. The review aims to list all potentially relevant value drivers in the reimbursement process of orphan drugs. A systematic literature review was performed; PubMed and Scopus databases were systematically searched for relevant publications until April 2015. Extracted data were summarized along key HTA elements. From the 2664 identified publications, 87 contained relevant information on the evaluation criteria of orphan drugs, but only 5 had direct information from the CEE region. The presentation of good clinical evidence seems to play a key role especially since this should be the basis of cost-effectiveness analyses, which have more importance in resource-constrained economies. Due to external price referencing of pharmaceuticals, the relative budget impact of orphan drugs is expected to be higher in CEE than in Western European (WE) countries unless accessibility of patients remains more limited in poorer European regions. Equity principles based on disease prevalence and non-availability of alternative treatment options may increase the price premium, however, societies must have some control on prices and a rationale based on multiple criteria in reimbursement decisions. The evaluation of orphan medicines should include multiple criteria to appropriately measure the clinical added value of orphan

Industry Perspective of Pediatric Drug Development in the United States: Involvement of the European Union Countries.

Science.gov (United States)

Onishi, Taku; Tsukamoto, Katsura; Matsumaru, Naoki; Waki, Takashi

2018-01-01

Efforts to promote the development of pediatric pharmacotherapy include regulatory frameworks and close collaboration between the US Food and Drug Administration and the European Medicines Agency. We characterized the current status of pediatric clinical trials conducted in the United States by the pharmaceutical industry, focusing on the involvement of the European Union member countries, to clarify the industry perspective. Data on US pediatric clinical trials were obtained from ClinicalTrials.gov . Binary regression analysis was performed to identify what factors influence the likelihood of involvement of European Union countries. A total of 633 US pediatric clinical trials that met inclusion criteria were extracted and surveyed. Of these, 206 (32.5%) involved a European Union country site(s). The results of binary regression analysis indicated that attribution of industry, phase, disease area, and age of pediatric participants influenced the likelihood of the involvement of European Union countries in US pediatric clinical trials. Relatively complicated or large pediatric clinical trials, such as phase II and III trials and those that included a broad age range of participants, had a significantly greater likelihood of the involvement of European Union countries ( P European Union countries, and (3) feasibility of clinical trials is mainly concerned by pharmaceutical industry for pediatric drug development. Additional incentives for high marketability may further motivate pharmaceutical industry to develop pediatric drugs.

76 FR 18198 - European Union-United States Atlantis Program

Science.gov (United States)

2011-04-01

... DEPARTMENT OF EDUCATION European Union-United States Atlantis Program AGENCY: Office of...)--Special Focus Competition: European Union-(EU) United States (U.S.) Atlantis Program Notice inviting... and Culture, European Commission for funding under a separate but parallel EU competition. Within this...

The current status and problems confronted in delivering precision medicine in Japan and Europe.

Science.gov (United States)

Bando, Hideaki

Precision medicine has been defined as "a predictive, preventive, personalized, and participatory health care service delivery model." Today, developments in next-generation sequencing and information technology have made precision medicine possible, with massive amounts of genetic, "omics," clinical, environmental, and lifestyle data now available. Unfortunately, differences in governmental support and health care regulations have resulted in heterogeneous progress among countries. In Japan, for example, precision cancer screening and treatments are increasingly being promoted, with collaboration among research, governmental, and pharmaceutical agencies taking place in the nationwide SCRUM-Japan cancer genome screening project. The missions of SCRUM-Japan are to deliver the most appropriate therapeutic agents to the most suitable patients, and to play key roles in the development of multiplex diagnostic products and new indications for targeted therapy. Starting in February 2015 and ending in March 2017, the aim is to enroll 4750 patients with cancer (2350 patients with lung cancer and 2400 patients with gastrointestinal tract cancer). Compared with other developed countries, investments in scientific innovation for biomedical and omics research are matched or even surpassed in Europe, but regulatory differences in each countries are a major hurdle to rapid implementation. Although market approval for pharmaceuticals is centralized through the European Medicines Agency, access to health care is heterogeneously regulated at national levels, which undermines the consistency, comparability, and quality of precision medicine for cancer patients in Europe. In this review, we focus on the current progress of precision medicine in Japan and Europe, and clarify the differences in progress and the hurdles faced moving forward. Copyright © 2017 Elsevier Inc. All rights reserved.

Highlights of articles published in annals of nuclear medicine 2016

International Nuclear Information System (INIS)

Jadvar, Hossein

2017-01-01

This article is the first installment of highlights of selected articles published during 2016 in the Annals of Nuclear Medicine, an official peer-reviewed journal of the Japanese Society of Nuclear Medicine. A companion article highlighting selected articles published during 2016 in the European Journal of Nuclear Medicine and Molecular Imaging, which is the official peer-reviewed journal of the European Association of Nuclear Medicine, will also appear in the Annals Nuclear Medicine. This new initiative by the respective journals will continue as an annual endeavor and is anticipated to not only enhance the scientific collaboration between Europe and Japan but also facilitate global partnership in the field of nuclear medicine and molecular imaging. (orig.)

Highlights of articles published in annals of nuclear medicine 2016

Energy Technology Data Exchange (ETDEWEB)

Jadvar, Hossein [University of Southern California, Division of Nuclear Medicine, Department of Radiology, Keck School of Medicine, Los Angeles, CA (United States)

2017-10-15

This article is the first installment of highlights of selected articles published during 2016 in the Annals of Nuclear Medicine, an official peer-reviewed journal of the Japanese Society of Nuclear Medicine. A companion article highlighting selected articles published during 2016 in the European Journal of Nuclear Medicine and Molecular Imaging, which is the official peer-reviewed journal of the European Association of Nuclear Medicine, will also appear in the Annals Nuclear Medicine. This new initiative by the respective journals will continue as an annual endeavor and is anticipated to not only enhance the scientific collaboration between Europe and Japan but also facilitate global partnership in the field of nuclear medicine and molecular imaging. (orig.)

Conclusions and recommendations of the European ORAMED project for practical interventional radiology and nuclear medicine

International Nuclear Information System (INIS)

Nikodemova, Denisa; Fueloep, Marko; Cabanekova, Helena

2012-01-01

The results of the recently published doses obtained by medical staff working in pulsed radiation fields, and performing interventional radiology (IR) or interventional cardiology (IC) procedures, as well as applications of radionuclides in nuclear medicine (NM), have shown significantly high levels of exposure, mainly to the hands and other parts of their bodies uncovered by protective equipment. The coordinated project ORAMED (Optimization of Radiation Protection of Medical Staff) was set-up by participation of 12 European countries and 34 IR/IC and NM departments, with the 5 main tasks: (i) optimization of radiation protection in IR and IC,with the aim to standardize a unified method of extremities and eye lens doses estimation, for 3 cardiac and 5 interventional diagnostic and therapeutic examinations; (ii) verification of the possibilities to use active personal dosemeters for typical pulsed radiation fields used in IR and IC; (iii) contribution to the extremities and eye lens dose reduction in nuclear medicine; (iv) development and application of a suitable eye lens dosemeter; and (v) elaboration of training materials and guidelines for radiation protection issues at IR, IC and NM workplaces. The present study presents some important results and recommendations for dose reduction and avoidance of some typical failures during work near ionizing radiation sources. (P.A.)

European symposium on precision medicine in allergy and airways diseases

DEFF Research Database (Denmark)

Muraro, A; Fokkens, W J; Pietikainen, S

2015-01-01

David Borrelli and with active participation of the European Respiratory Society (ERS), the European Federations of Allergy and Airways Diseases Patients Associations (EFA), the Global Allergy and Asthma European Network (Ga2len), Allergic Rhinitis and Its Impact on Asthma (ARIA) and the Respiratory....... This report summarizes the key messages delivered during the symposium by the speakers, including the EU Commissioner for Health and Food Safety Vitenys Andriukaitis. The Commissioner underscored the need for optimal patient care in Europe, supporting joint action plans for disease prevention, patient...... the epidemic of Allergy and Asthma in Europe. The socio-economic impact of allergies and chronic airways diseases cannot be underestimated, as they represent the most frequently diagnosed chronic non-communicable diseases in the EU. Despite the fact that 30% of the total European population is nowadays...

The text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, the European Atomic Energy Community and the Agency in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

International Nuclear Information System (INIS)

1989-05-01

On 5 April 1989 the Agency received in respect of the European Atomic Energy Community and Spain the notification required by Article 23(a) of the Agreement of 5 April 1973 between Belgium, Denmark, the Federal Republic of Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, the European Atomic Energy Community and the Agency, which therefore came into force for Spain on that date

Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases.

Science.gov (United States)

Stefanska, Anna M; Distlerová, Dorota; Musaus, Joachim; Olski, Thorsten M; Dunder, Kristina; Salmonson, Tomas; Mentzer, Dirk; Müller-Berghaus, Jan; Hemmings, Robert; Veselý, Richard

2017-10-01

The European Union (EU) Paediatric Regulation requires that all new medicinal products applying for a marketing authorisation (MA) in the EU provide a paediatric investigation plan (PIP) covering a clinical and non-clinical trial programme relating to the use in the paediatric population, unless a waiver applies. Conducting trials in children is challenging on many levels, including ethical and practical issues, which may affect the availability of the clinical evidence. In scientifically justified cases, extrapolation of data from other populations can be an option to gather evidence supporting the benefit-risk assessment of the medicinal product for paediatric use. The European Medicines Agency (EMA) is working on providing a framework for extrapolation that is scientifically valid, reliable and adequate to support MA of medicines for children. It is expected that the extrapolation framework together with therapeutic area guidelines and individual case studies will support future PIPs. Extrapolation has already been employed in several paediatric development programmes including biological treatment for immune-mediated diseases. This article reviews extrapolation strategies from MA applications for products for the treatment of juvenile idiopathic arthritis, paediatric psoriasis and paediatric inflammatory bowel disease. It also provides a summary of extrapolation advice expressed in relevant EMA guidelines and initiatives supporting the use of alternative approaches in paediatric medicine development. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Should Anthroposophic Medicinal Products Be Regulated in Europe?

Science.gov (United States)

Michaux, Geneviève

2017-03-01

European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.

Science.gov (United States)

Schutte, Katrin; Szczepanska, Anna; Halder, Marlies; Cussler, Klaus; Sauer, Ursula G; Stirling, Catrina; Uhlrich, Sylvie; Wilk-Zasadna, Iwona; John, David; Bopst, Martin; Garbe, Joerg; Glansbeek, Harrie L; Levis, Robin; Serreyn, Pieter-Jan; Smith, Dean; Stickings, Paul

2017-07-01

This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations). To facilitate the global regulatory acceptance of non-animal methods for the potency testing of, e.g., human diphtheria and tetanus vaccines and veterinary swine erysipelas vaccines, international convergence on the scientific principles of the use of appropriately validated in vitro assays for replacing in vivo methods was identified as an overarching goal. The establishment of scientific requirements for new assays was recognized as a further means to unify regulatory approaches in different jurisdictions. It was recommended to include key regulators and manufacturers early in the corresponding discussions. Manufacturers and responsible expert groups, e.g. at the European Directorate for the Quality of Medicines and Health Care of the Council of Europe or the European Medicines Agency, were invited to consider leadership for international collaboration. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

White paper of nuclear medicine

International Nuclear Information System (INIS)

2012-10-01

This document aims at proposing a synthetic presentation of nuclear medicine in France (definition, strengths and weaknesses, key figures about practices and the profession, stakes for years to come), a description of the corresponding education (speciality definition, abilities and responsibilities, diploma content, proposition by the European Society of Radiology and by the CNIPI, demography of the profession), and an overview of characteristics of nuclear medicine (radio-pharmacy, medical physics, paramedical personnel in nuclear medicine, hybrid imagery, therapy, relationships with industries of nuclear medicine, relationships with health authorities)

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Slovenia

International Nuclear Information System (INIS)

2007-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement [es

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Bulgaria

International Nuclear Information System (INIS)

2009-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement [fr

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Bulgaria

International Nuclear Information System (INIS)

2009-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement [es

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Bulgaria

International Nuclear Information System (INIS)

2009-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Cyprus

International Nuclear Information System (INIS)

2008-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Slovenia

International Nuclear Information System (INIS)

2007-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement

Quality assurance and harmonisation of nuclear medicine investigations in Europe

International Nuclear Information System (INIS)

Bergmann, H.; Busemann-Sokole, E.; Horton, P.W.

1995-01-01

A survey of all member societies of the European Association of Nuclear Medicine has shown that a satisfactory degree of harmonisation exists for the quality assurance of the preparation and handling of radiopharmaceuticals and the performance of nuclear medicine instrumentation. However, variations were found in acquisition protocols, data analysis and the interpretation and presentation of clinical results. Harmonisation of these areas of a nuclear medicine investigation would help ensure the overall quality. A European initiative is proposed to collect and collate procedures in these areas in order to produce a reference framework of good practice for the acquisition, analysis and interpretation of nuclear medicine investigations. This would involve collaboration between national societies and exchange of information with and support from European organisations, taking into account relevant international activities. The reference framework should be compatible with quality management guidelines. (orig.)

Risk-based approach to developing a national residue sampling plan for testing under European Union regulation for veterinary medicinal products and coccidiostat feed additives in domestic animal production.

Science.gov (United States)

Danaher, Martin; Shanahan, Conor; Butler, Francis; Evans, Rhodri; O'Sullivan, Dan; Glynn, Denise; Camon, Tim; Lawlor, Peadar; O'Keeffe, Michael

2016-07-01

A ranking system for veterinary medicinal products and coccidiostat feed additives has been developed as a tool to be applied in a risk-based approach to the residue testing programme for foods of animal origin in the Irish National Residue Control Plan (NRCP). Three characteristics of substances that may occur as residues in food are included in the developed risk ranking system: Potency, as measured by the acceptable daily intake assigned by the European Medicines Agency Committee for Medicinal Products for Veterinary Use, to each substance; Usage, as measured by the three factors of Number of Doses, use on Individual animals or for Group treatment, and Withdrawal Period; and Residue Occurrence, as measured by the number of Non-Compliant Samples in the NRCP. For both Number of Doses and Non-Compliant Samples, data for the 5-year period 2008-12 have been used. The risk ranking system for substances was developed for beef cattle, sheep and goats, pigs, chickens and dairy cattle using a scoring system applied to the various parameters described above to give an overall score based on the following equation: Potency × Usage (Number of Doses + Individual/Group Use + Withdrawal Period) × Residue Occurrence. Applying this risk ranking system, the following substances are ranked very highly: antimicrobials such as amoxicillin (for all species except pigs), marbofloxacillin (for beef cattle), oxytetracycline (for all species except chickens), sulfadiazine with trimethoprim (for pigs and chickens) and tilmicosin (for chickens); antiparasitic drugs, such as the benzimidazoles triclabendazole (for beef and dairy cattle), fenbendazole/oxfendazole (for sheep/goats and dairy cattle) and albendazole (for dairy cattle), the avermectin ivermectin (for beef cattle), and anti-fluke drugs closantel and rafoxanide (for sheep/goats); the anticoccidials monensin, narasin, nicarbazin and toltrazuril (for chickens). The risk ranking system described is a relatively simple system

The role of the Therapeutic Goods Administration and the Medicine and Medical Devices Safety Authority in evaluating complementary and alternative medicines in Australia and New Zealand

International Nuclear Information System (INIS)

Ghosh, Dilip; Skinner, Margot; Ferguson, Lynnette R.

2006-01-01

Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) administers the provision of legislation in New Zealand. In December 2003 the Australian and New Zealand governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices prescription, over-the-counter and complementary medicines. A single agency will replace the Australian TGA and the New Zealand Medsafe. The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. The major activities of the new joint Australia New Zealand therapeutic products agency are in product licensing, specifying labelling standards and setting the advertising scheme, together with determining the risk classes of medicines and creating an expanded list of ingredients permitted in Class I medicines. A new, expanded definition of complementary medicines is proposed and this definition is currently under consultation. Related Australian and New Zealand legislation is being developed to implement the joint scheme. Once this legislation is passed, the Treaty will come into force and the new joint regulatory scheme will begin. The agency is expected to commence operation no later than 1 July 2006 and will result in a single agency to regulate complementary and alternative medicines

Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

DEFF Research Database (Denmark)

Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

2017-01-01

BACKGROUND: The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse effects...... of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. METHODS: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total...... of 1913 patients) submitted to the European Medicines Agency for marketing approval for the indication of stress urinary incontinence in women. We used data from the clinical study reports (totalling 6870 pages and including individual patient data) to assess benefits (including frequency of incontinence...

Medicine non-adherence in kidney transplantation.

Science.gov (United States)

Williams, Allison Fiona; Manias, Elizabeth; Gaskin, Cadeyrn J; Crawford, Kimberley

2014-06-01

The increasing prevalence of chronic kidney disease, the relative shortage of kidney donors and the economic- and health-related costs of kidney transplant rejection make the prevention of adverse outcomes following transplantation a healthcare imperative. Although strict adherence to immunosuppressant medicine regimens is key to preventing kidney rejection, evidence suggests that adherence is sub-optimal. Strategies need to be developed to help recipients of kidney transplants adhere to their prescribed medicines. This review has found that a number of factors contribute to poor adherence, for example, attitudes towards medicine taking and forgetfulness. Few investigations have been conducted, however, on strategies to enhance medicine adherence in kidney transplant recipients. Strategies that may improve adherence include pharmacist-led interventions (incorporating counselling, medicine reviews and nephrologist liaison) and nurse-led interventions (involving collaboratively working with recipients to understand their routines and offering solutions to improve adherence). Strategies that have shown to have limited effectiveness include supplying medicines free of charge and providing feedback on a participant's medicine adherence without any educational or behavioural interventions. Transplantation is the preferred treatment option for people with end-stage kidney disease. Medicine non-adherence in kidney transplantation increases the risk of rejection, kidney loss and costly treatments. Interventions are needed to help the transplant recipient take all their medicines as prescribed to improve general well-being, medicine safety and reduce healthcare costs. © 2014 European Dialysis and Transplant Nurses Association/European Renal Care Association.

78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

Science.gov (United States)

2013-11-22

.... FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is...

TEDDY EPMD: A European Paediatric Medicines Database

Czech Academy of Sciences Publication Activity Database

Felisi, M.; Padula, R.; Bartoloni, F.; Grosch-Wörner, C.; Kagedal, B.; Mellado Peňa, M.J.; Parry, J.; Stuchlík, Aleš; Verhamme, K.; Ceci, A.

2009-01-01

Roč. 11, 1-2 (2009), s. 31-39 ISSN 1389-2827 Grant - others:EC(XE) LSHBCT-2005-005126 Institutional research plan: CEZ:AV0Z50110509 Keywords : pediatric medicine * databases * children Subject RIV: FP - Other Medical Disciplines

76 FR 71345 - Patient Safety Organizations: Voluntary Relinquishment From Emergency Medicine Patient Safety...

Science.gov (United States)

2011-11-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From Emergency Medicine Patient Safety Foundation AGENCY: Agency for... notification of voluntary relinquishment from Emergency Medicine Patient Safety Foundation of its status as a...

Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)

NARCIS (Netherlands)

Simundic, Ana-Maria; Church, Stephen; Cornes, Michael P.; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Nikolac, Nora; van Dongen-Lases, Edmee; Eker, Pinar; Kovalevskaya, Svjetlana; Kristensen, Gunn B. B.; Sprongl, Ludek; Sumarac, Zorica

2015-01-01

Abstract Background: An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines. Methods: A structured

Highlights of the Annual Congress of the European Association of Nuclear Medicine, Helsinki 2004, and a dash of horizon scanning

International Nuclear Information System (INIS)

Ell, Peter J.

2005-01-01

The Annual Congress of the European Association of Nuclear Medicine represents the major scientific and professional event in the field of nuclear medicine in Europe. Specialists from all allied professions meet to discuss the latest findings and discoveries. A very large industrial exhibition demonstrates the latest technological innovations and developments. This Highlights Lecture summarises the scientific and medical advances discussed at this important gathering. The lecture covers a significant proportion of the data presented and/or discussed in up-to-date reviews, and places some of the trends encountered in the context of the evolution of the field as a whole. There is much food for thought in most areas of nuclear medicine: advances in instrumentation and data processing, progress in radiochemistry and pharmacy, novel diagnostics and therapeutics, and new insights in known areas of clinical application such as neurology and psychiatry, cardiology, oncology, endocrine disorders, paediatrics, nephro-urology and musculoskeletal disorders. This Highlights Lecture is, however, only a brief resume of the vast amount of data discussed, which can be found in much greater detail in the Congress Proceedings, published as volume 31, supplement 2 of Eur J Nucl Med Mol Imagingin August 2004. (orig.)

Reputation-Seeking by a Government Agency in Europe

DEFF Research Database (Denmark)

Bækkeskov, Erik

2017-01-01

Reputation-seeking can explain some decisions of U.S. federal agencies. However, it has remained unclear whether it could be used in the European context where agencies have proliferated in national and regional governance in the past few decades. This article shows that reputation-seeking can oc...

Medical-legal aspects of the fungal infection drug therapy in neonatology: evidence-based medicine and off-label prescribing

Directory of Open Access Journals (Sweden)

Marta Ciuffi

2014-06-01

Full Text Available The aim of this paper is to focus on the well-known issue of the clinical use of off-label drug therapy in neonatology with respect to evidence-based medicine, with particular reference to antifungal products, in comparison with the wider use in pediatric and adult population. Then we considered the new regulatory approaches carried out in the past decade by the FDA (Food and Drug Administration and the EMA (European Medicine Agency, aimed to improve newborn and children population inclusion into scientific trials and to promote drug labeling with respect to pediatric indications, and the goals nowadays achieved through the American Pediatric Research Equity Act / Best Pharmaceuticals for Children Act and the European Pediatric Investigation Plans. Finally we pointed out, on the basis of the Italian regulatory framework, the Italian medical-legal liability profiles related to the use of off-label therapies in neonatology. Further efforts are required in the international context to carry forward the process started while in the particular Italian scenario it is to be hoped that a general change of mind towards the off-label drug use in neonatology clinical practice may take place.

EU policies in personalized medicine-related technologies

NARCIS (Netherlands)

Gaisser, S.; Vignola-Gagné, E.; Hüsing, B.; Enzing, C.; Valk, T. van der

2009-01-01

Against the background of a number of first drug-diagnostic co-products developed and introduce into the European market, European decision-makers feel impelled to react and position themselves in the field of personalized medicine. Their reactions cover a broad range, from the analysis of knowledge

Interactions of OTCs with prescription and non- prescription medicines

African Journals Online (AJOL)

Repro

responsible self-medication with OTC drugs. In many European countries such medicines ... popular OTC, herbal and complementary medicines ... Congestive cardiac failure and aggravated hyper- ... Ankle oedema is a common side-effect.

Climate policy in other countries of the European Union. An outline

International Nuclear Information System (INIS)

Kroon, P.

2005-08-01

Within the framework of the second evaluation memorandum on climate policy in the Netherlands an overview is given of the climate policy in 15 other countries of the European Union. The overview is mainly based on progress reports on greenhouse gases emission, issued by the European Environment Agency (EEA) and a database of policy and measures in the field of climatic change, maintained by the International Energy Agency (IEA). Next to EU Directives as an important base for policy in the 15 countries, the the covenant on CO2 emission for new cars between ACEA (European Automobile Manufacturers Association) and the European Commission is considered to be an important agreement for climate policy in the EU counties [nl

Chemokine Receptor CCR5 Antagonist Maraviroc: Medicinal Chemistry and Clinical Applications

Science.gov (United States)

Xu, Guoyan G.; Guo, Jia; Wu, Yuntao

2015-01-01

The human immunodeficiency virus (HIV) causes acquired immumodeficiency syndrome (AIDS), one of the worst global pandemic. The virus infects human CD4 T cells and macrophages, and causes CD4 depletion. HIV enters target cells through the binding of the viral envelope glycoprotein to CD4 and the chemokine coreceptor, CXCR4 or CCR5. In particular, the CCR5-utilizing viruses predominate in the blood during the disease course. CCR5 is expressed on the surface of various immune cells including macrophages, monocytes, microglia, dendric cells, and active memory CD4 T cells. In the human population, the CCR5 genomic mutation, CCR5Δ32, is associated with relative resistance to HIV. These findings paved the way for the discovery and development of CCR5 inhibitors to block HIV transmission and replication. Maraviroc, discovered as a CCR5 antagonist, is the only CCR5 inhibitor that has been approved by both US FDA and the European Medicines Agency (EMA) for treating HIV/AIDS patients. In this review, we summarize the medicinal chemistry and clinical studies of Maraviroc. PMID:25159165

[A journey to the foundations of classical medicine].

Science.gov (United States)

Cruz-Coke M, Ricardo

2007-08-01

The author narrates his trips, between 1951 and 2006, to the main historical sites of antique medicine, where physicians of pre-Columbian cultures of Mexico and Peru, Egypt, Greco Latin culture and Islamic civilizations, lived. The trip ends with a visit to medieval European medicine before Renaissance. A description of the main historical sites and the features of these medical and sanitary cultures is made. In antique civilizations, diseases were considered a punishment of pagan deities. Supernatural and magical influences were decisive in medical practice. The Greco Latin culture of Galen and Hippocrates freed manhood from these causes of diseases and gave a rational basis to the practice of medicine. The Islamic civilization allowed the transmission of Greco Latin culture to medieval Europe. This permitted the renaissance of European creativity and the foundation of modern scientific medicine in the sixteenth century. The author highlights the main virtues of classical Greco Latin medicine, that are the foundations of humanistic thoughts that will restrin the technological revolution of modern medicine.

The text of the agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, the Netherlands, the European Atomic Energy Community and the Agency in connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Latvia

International Nuclear Information System (INIS)

2009-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, the Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement. The Agreement and the Protocol thereto, which came into force for the above-mentioned original signatories on 21 February 1977, have also entered into force for Austria, Cyprus, Estonia, Finland, Greece, Hungary, Lithuania, Malta, Poland, Portugal, Slovakia, Slovenia, Spain and Sweden. The Agency received from the Republic of Latvia on 17 March 2008 and from the European Atomic Energy Community on 1 October 2008, the notifications required by Article 23(a) of the Agreement. Accordingly, the Agreement entered into force for Latvia on 1 October 2008

European experience of regulating distance selling of medicines for Ukraine.

Science.gov (United States)

Pashkov, Vitalii; Hrekov, Yevhen; Hrekova, Maryna

Some countries have already tried and tested mechanisms of regulating distance sales as form of distribution of medicines that have been used more or less effectively for a fairly long time. Herewith, so far, the approach of the competent authorities of some countries including Ukraine can be called prevailing in quantitative terms under which the official prohibition on distance sales of medicines is set. The aim of this study is a detailed examination of the nature of the prohibition of the medicines distance selling in Ukraine, namely the an analysis of advantages and disadvantages of this form of distribution of medicines and identification of appropriate ways for gradual repeal of the prohibition in terms of regulatory reform in Ukraine in the sphere of circulation of medicines due to the process of adaptation of statutory regulation in this area to the EU legislation. This study is based on Ukrainian regulation acts, Council Directives 97/7/EC, 2000/31/EC, 2001/83/EC, scientific works and opinions of progressiveminded people in this sphere. Such methods as dialectical, comparative, analytic, synthetic and comprehensive have been used in the article. Reception of the described experience of regulation in EU will allow a further review of the principles of regulation in Ukraine in the sphere of medicines with a shift in the main emphasis in the direction of ensuring adequate consumer rights in this area and preventing the risks of patients' and public health.

A Just Distribution of Health Care in the Case of Orphan Medicinal Products: Aligning the Interests of European Economic Integration and National Welfare Policy

DEFF Research Database (Denmark)

Faeh, Andrea

2012-01-01

resources is concerned. The EU is very proactive in fostering research and development of medicinal products aimed at treating patients who suffer from rare diseases. The European incentive scheme (Regulation (EC) No. 141/2000) has been a considerable success but, although products are developed......, they are not necessarily available to the patient. This is due to the fact that decisions about the price and the reimbursement of these (very expensive) products are made at the national level. This article draws up a framework for distributing limited health resources where medicinal products for rare diseases (orphan...... medicine) are concerned. The provision in the Patients’ Rights Directive (Dir. 2011/27/EU) on cooperation in health care among the Member States is discussed through the lens of ‘solidarity’ (understood as mutual cooperation) in order to align and remedy the deficits in the system and guarantee the patient...

[European Marketing Authorisation: a long process. Experiences of small biotech companies with the ATMP regulation].

Science.gov (United States)

Buljovčić, Z

2011-07-01

On 30 December 2008, the Regulation (EC) 1394/2007 on advanced therapy medicinal products (ATMPs) entered into force. Herewith the first EU-wide regulatory framework for ATMPs was established. It requires a central marketing authorisation application to the EMA (European Medicinal Agency). This new framework especially changes the code of regulatory practice for tissue engineered products (TEPs), as no registration procedure had been previously required for autologous TEPs. This also meant that no clinical proof of efficacy achieved by a pivotal clinical trial was necessary. Difficulties and their background as well as the vast requirements for product development that have to be addressed by small companies within a very short time frame are presented. Hereby, it is obvious that regulatory experience which is required to identify and implement the resulting implications was not in place yet and still had to be established. The lack of regulatory experience also resulted in difficulties with scientific advice preparation, expectations toward regulatory agencies, consultants, and transformation of regulatory requirements. Addressing the regulatory requirements within the transition period is even more difficult for entrepreneurs with products which are assigned for indications resulting in complex challenges to the trial design. Due to the enormous time pressure to generate data and due to the implied financial pressure, different adaptation strategies are evolving. In Germany the "hospital exemption" according to §4b AMG (German Medicinal Products Law) is of major importance. A reorientation toward acellular products and a slow down in development of new ATMP products is expected.

Participation of industry experts in the elaboration of monographs and chapters of the European Pharmacopoeia.

Science.gov (United States)

Rose, Ulrich

2016-10-10

The European Pharmacopoeia represents an important element in the European regulatory system for medicines. It is elaborated in a co-operation of experts from authorities, academia and industry, assisted by scientific staff from the European Directorate for the Quality of Medicines & HealthCare (EDQM). This article describes the principles of its elaboration with particular focus on the involvement of industry experts. Copyright © 2016 Elsevier B.V. All rights reserved.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

Science.gov (United States)

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

From Hippocrates to modern medicine.

Science.gov (United States)

Orfanos, C E

2007-07-01

Hippocrates was the first to introduce the concept of 'physis' and to transform hieratic or theocratic medicine into rational medicine. The overall construction of the Asclepieion on Kos clearly indicates that he and his school followed a holistic concept, combining scientific thought with drug therapy, diet schedules, and physical and mental exercise, also asking for God's help. Hippocrates also formulated the first standards and ethical rules to be followed in medical profession, which are still valid today. The knowledge of Graeco-Roman medicine has been transferred by Arab scholars into the West, whereas renaissance, urbanization, and industrialisation have changed its face over the centuries. With the entrance of molecular technology and economy, modern medicine now faces the risk of becoming itself industrialized. Correct use of new scientific knowledge, individualized management with a Hippocratic holistic approach and compassionate sympathy for the patient who suffers, should be considered in the years to come for maintaining the level of medical profession. The venue of our European Congress in Rhodes is very close to Kos, another historic Aegean island, the place where Hippocrates has given the first professional standards in European medicine and in medicine in general. They were established 2600 years ago and are still valid today.(1,2) If one draws a red line and marks some cornerstones of the evolution that has taken place in medicine over the past centuries, it is evident that these first rules formulated by Hippocrates and his school also reveal the future responsibilities for our profession and make them better recognizable and more conclusive.

European pet travel: misleading information from veterinarians and government agencies.

Science.gov (United States)

Davidson, R K; Robertson, L J

2012-12-01

Inter-country travel of companion animals provides an opportunity for introduction of zoonotic pathogens, such as rabies virus and Echinococcus spp. Regulations are in place to control this threat, but Schengen Agreements mean that border controls between some European countries are minimal, and animals may enter countries without any checks that they have been appropriately treated. Veterinarians provide an important source of information for people intending to travel with their pets. We conducted a telephone survey to investigate provision of correct advice to someone intending to travel with their dog to Norway. Mainland Norway is considered free of both rabies and E. multilocularis and is a signatory to the Schengen Agreement. Ten randomly selected veterinary clinics were surveyed in Austria, Belgium (Wallonia), Finland, France, Germany, Norway, Sweden, Switzerland and United Kingdom. The information provided was scored as correct, incorrect or incomplete. The information provided by secondary information sources (website or government agency), which the clinic had referred the caller to, was also assessed (correct, incorrect, incomplete). Whilst the majority of clinics provided appropriate information regarding rabies, many clinics did not provide correct information regarding treatment for E. multilocularis. Less than one in 10 clinics provided the correct information regarding both pathogens directly at the time of calling. The correct information was obtained, once taking into account secondary sources, just 62% of the time. Countrywise, most clinics in Finland provided correct advice, either directly or indirectly via referring the caller to another source, whilst the majority in Belgium, Germany and France did not. The apparent paucity of readily accessible, correct advice for owners intending to travel with their dogs is concerning. The compulsory treatment regulations are only as good as the checks that ensure compliance, and this is also lacking in

Priorities in national space strategies and governance of the member states of the European Space Agency

Science.gov (United States)

Adriaensen, Maarten; Giannopapa, Christina; Sagath, Daniel; Papastefanou, Anastasia

2015-12-01

The European Space Agency (ESA) has twenty Member States with a variety of strategic priorities and governance structures regarding their space activities. A number of countries engage in space activities exclusively though ESA, while others have also their own national space programme. Some consider ESA as their prime space agency and others have additionally their own national agency with respective programmes. The main objective of this paper is to provide an up-to date overview and a holistic assessment of strategic priorities and the national space governance structures in 20 ESA Member States. This analysis and assessment has been conducted by analysing the Member States public documents, information provided at ESA workshop on this topic and though unstructured interviews. The paper is structured to include two main elements: priorities and trends in national space strategies and space governance in ESA Member States. The first part of this paper focuses on the content and analysis of the national space strategies and indicates the main priorities and trends in Member States. The priorities are categorised with regards to technology domains, the role of space in the areas of sustainability and the motivators that boost engagement in space. These vary from one Member State to another and include with different levels of engagement in technology domains amongst others: science and exploration, navigation, Earth observation, human space flight, launchers, telecommunications, and integrated applications. Member States allocate a different role of space as enabling tool adding to the advancement of sustainability areas including: security, resources, environment and climate change, transport and communication, energy, and knowledge and education. The motivators motivating reasoning which enhances or hinders space engagement also differs. The motivators identified are industrial competitiveness, job creation, technology development and transfer, social benefits

French local agencies of energy control; Agences locales francaise de maitrise de l'energie

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-07-01

In the framework of the SAVE program, the European Commission brings financial assistance to the creation of local or regional agencies of energy control in municipalities and regions. The main criteria are the impacts on the energy demand, the reinforcement of the economic and social cohesion, the environmental quality and the contribution to the economic development and the employment creation. In this document, realized by Energie-Cites, the Ademe objective is to present a state of the art of french local agencies. Ten agencies are presented as case study. Each case deals with the following topics: the main context of the action which details the energy and the environmental policy of the municipality, the creation and the description of the agency, the implemented actions and the perspectives. (A.L.B.)

The European Trauma Course (ETC) and the team approach

DEFF Research Database (Denmark)

Lott, Carsten; Araujo, Rui; Cassar, Mary Rose

2009-01-01

The European Trauma Course (ETC) was officially launched during the international conference of the European Resuscitation Council (ERC) in 2008. The ETC was developed on behalf of ESTES (European Society of Trauma and Emergency Surgery), EuSEM (European Society of Emergency Medicine), the ESA...... (European Society of Anaesthesiology) and the ERC. The objective of the ETC is to provide an internationally recognised and certified life support course, and to teach healthcare professionals the key principles of the initial care of severely injured patients. Its core elements, that differentiates it from...

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Estonia and the Slovak Republic

International Nuclear Information System (INIS)

2007-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement [es

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Estonia and the Slovak Republic

International Nuclear Information System (INIS)

2007-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement

Improving quality in the preanalytical phase through innovation, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE)

DEFF Research Database (Denmark)

Lippi, Giuseppe; Baird, Geoffrey S.; Banfi, Giuseppe

2017-01-01

process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed...... at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years. Hence, this collective article follows the previous three opinion papers that were published by the EFLM WGPRE on the same topic, and brings together the summaries...

Imperial Medicine in a Changing World: The Fourth International Congresses on Tropical Medicine and Malaria, 1948.

Science.gov (United States)

Wells, Julia

2016-01-01

The close connections between colonialism and tropical medicine have been widely discussed by historians over the last fifty years. However, few authors consider the relationship between tropical medicine and European and North American imperialism in the immediate post-World War II period. This article examines the Fourth International Congresses on Tropical Medicine and Malaria, held jointly in Washington in 1948. Using the research presented during the conference, it questions to what degree the specialisation had changed in the postwar period. It argues that although some changes are discernable, imperial traditions and relationships remained firmly embedded within the tropical medicine of the congress.

Modern treatment of short bowel syndrome

DEFF Research Database (Denmark)

Jeppesen, Palle B

2013-01-01

Recently, the US Food and Drug Administration and the European Medicines Agency approved the glucagon-like peptide 2 analogue, teduglutide, for the treatment of short bowel syndrome (SBS), and this review describes the physiological basis for its clinical use.......Recently, the US Food and Drug Administration and the European Medicines Agency approved the glucagon-like peptide 2 analogue, teduglutide, for the treatment of short bowel syndrome (SBS), and this review describes the physiological basis for its clinical use....

Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development.

Science.gov (United States)

Bertram, Timothy A; Johnson, Peter C; Tawil, Bill J; Van Dyke, Mark; Hellman, Kiki B

2015-10-01

TERMIS-AM Industry Committee (TERMIS-AM/IC), in collaboration with the TERMIS-Europe (EU)/IC, conducted a symposium involving the European Medicines Agency and the U.S. Food and Drug Administration (FDA) toward building an understanding of the rational basis for regulatory decision-making and providing a framework for decisions made during the evaluation of safety and efficacy of TE/RM technologies. This symposium was held in August 2012 during the TERMIS-WC in Vienna, Austria. Emerging from this international initiative by the European Union and the United States, representatives from the respective agencies demonstrated that there are ongoing interagency efforts for developing common national practices toward harmonization of regulatory requirements for the TE/RM products. To extend a broad-based understanding of the role of science in regulatory decision-making, TERMIS-AM/IC, in cooperation with the FDA, organized a symposium at the 2014 TERMIS-AM Annual Meeting, which was held in Washington, DC. This event provided insights from leaders in the FDA and TERMIS on the current status of regulatory approaches for the approved TE/RM products, the use of science in making regulatory decisions, and TE/RM technologies that are in the development pipeline to address unmet medical needs. A far-ranging discussion with FDA representatives, industrialists, physicians, regenerative medicine biologists, and tissue engineers considered the gaps in today's scientific and regulatory understanding of TE/RM technologies. The identified gaps represent significant opportunities to advance TE/RM technologies toward commercialization.

Precision medicine in allergic disease-food allergy, drug allergy, and anaphylaxis-PRACTALL document of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma and Immunology.

Science.gov (United States)

Muraro, A; Lemanske, R F; Castells, M; Torres, M J; Khan, D; Simon, H-U; Bindslev-Jensen, C; Burks, W; Poulsen, L K; Sampson, H A; Worm, M; Nadeau, K C

2017-07-01

This consensus document summarizes the current knowledge on the potential for precision medicine in food allergy, drug allergy, and anaphylaxis under the auspices of the PRACTALL collaboration platform. PRACTALL is a joint effort of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma and Immunology, which aims to synchronize the European and American approaches to allergy care. Precision medicine is an emerging approach for disease treatment based on disease endotypes, which are phenotypic subclasses associated with specific mechanisms underlying the disease. Although significant progress has been made in defining endotypes for asthma, definitions of endotypes for food and drug allergy or for anaphylaxis lag behind. Progress has been made in discovery of biomarkers to guide a precision medicine approach to treatment of food and drug allergy, but further validation and quantification of these biomarkers are needed to allow their translation into practice in the clinical management of allergic disease. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

Science.gov (United States)

Buchholzer, Marie-Luise; Werner, Christine; Knoess, Werner

2014-03-01

For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products. Copyright © 2014 Elsevier Inc. All rights reserved.

The text of the agreement between Belgium, Denmark, the Federal Republic of Germany, Finland, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, the European Atomic Energy Community and the Agency in connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Finland

International Nuclear Information System (INIS)

2004-01-01

Article 23(a) of the Agreement of 5 April 1973 between Belgium, Denmark, the Federal Republic of Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, the European Atomic Energy Community and the Agency in implementation of Article III (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement. On 18 September 1995 the Agency received in respect of the European Atomic Energy Community and Finland the notifications required by Article 23(a) of the Agreement. For practical accounting purposes as proposed in the notifications, the Agreement came into force for Finland on 1 October 1995

The Limits of Agencification in the European Union

NARCIS (Netherlands)

Scholten, Mira; van Rijsbergen, Marloes

2014-01-01

Although not explicitly regulated by the EU treaties, EU agencies not only exist but also have increased in number and power. In addition, while EU agencies may exercise very similar functions to those of the Commission, Articles 290 and 291 of the Treaty on the Functioning of the European Union

French local agencies of energy control; Agences locales francaise de maitrise de l'energie

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-07-01

In the framework of the SAVE program, the European Commission brings financial assistance to the creation of local or regional agencies of energy control in municipalities and regions. The main criteria are the impacts on the energy demand, the reinforcement of the economic and social cohesion, the environmental quality and the contribution to the economic development and the employment creation. In this document, realized by Energie-Cites, the Ademe objective is to present a state of the art of french local agencies. Ten agencies are presented as case study. Each case deals with the following topics: the main context of the action which details the energy and the environmental policy of the municipality, the creation and the description of the agency, the implemented actions and the perspectives. (A.L.B.)

Update of the ERS international Adult Respiratory Medicine syllabus for postgraduate training.

Science.gov (United States)

Tabin, Nathalie; Mitchell, Sharon; O'Connell, Elaine; Stolz, Daiana; Rohde, Gernot

2018-03-01

First published in 2006, the first European core syllabus in Adult Respiratory Medicine was developed with the intention of harmonising education and training throughout Europe. Internationally recognised by the European Union of Medical Specialists and identified as the first document of its kind in respiratory medicine, it has provided a comprehensive guide for both local and national institutions in the development of adult respiratory training programmes. Like all fields in education, respiratory medicine is an ever-changing area and as such, respective syllabi, curricula and training programmes must adapt and diversify in line with the evolution of core medical concepts. Given the proven importance of the Adult Respiratory Medicine syllabus from both a national and international standpoint, it is of equal importance that said syllabus remains abreast of emerging trends so as to sustain the synchronisation of respiratory medicine in Europe. In order to develop an updated programme, a comprehensive review process of the current syllabus is a necessary endeavour and a step that the European Respiratory Society (ERS) has undertaken through the process of a needs assessment.

Innovative regenerative medicines in the EU: a better future in evidence?

Science.gov (United States)

Corbett, Mark S; Webster, Andrew; Hawkins, Robert; Woolacott, Nerys

2017-03-08

Despite a steady stream of headlines suggesting they will transform the future of healthcare, high-tech regenerative medicines have, to date, been quite inaccessible to patients, with only eight having been granted an EU marketing licence in the last 7 years. Here, we outline some of the historical reasons for this paucity of licensed innovative regenerative medicines. We discuss the challenges to be overcome to expedite the development of this complex and rapidly changing area of medicine, together with possible reasons to be more optimistic for the future. Several factors have contributed to the scarcity of cutting-edge regenerative medicines in clinical practice. These include the great expense and difficulties involved in planning how individual therapies will be developed, manufactured to commercial levels and ultimately successfully delivered to patients. Specific challenges also exist when evaluating the safety, efficacy and cost-effectiveness of these therapies. Furthermore, many treatments are used without a licence from the European Medicines Agency, under "Hospital Exemption" from the EC legislation. For products which are licensed, alternative financing approaches by healthcare providers may be needed, since many therapies will have significant up-front costs but uncertain benefits and harms in the long-term. However, increasing political interest and more flexible mechanisms for licensing and financing of therapies are now evident; these could be key to the future growth and development of regenerative medicine in clinical practice. Recent developments in regulatory processes, coupled with increasing political interest, may offer some hope for improvements to the long and often difficult routes from laboratory to marketplace for leading-edge cell or tissue therapies. Collaboration between publicly-funded researchers and the pharmaceutical industry could be key to the future development of regenerative medicine in clinical practice; such collaborations

ACER: demystifying the European energy supervisor from a consumer perspective

NARCIS (Netherlands)

Lavrijssen, S.A.C.M.; Bordei, I.

2012-01-01

The European energy regulatory triangle, consisting of National Regulatory Authorities (NRAs), the European Commission and the newly established Agency for the Cooperation of Energy Regulators (ACER), has an important role in enhancing cross border trade and wholesale market competition and

Monitoring of occupational safety and health in the European Union : report to the European Agency

NARCIS (Netherlands)

Smulders, P.

2002-01-01

This project was carried out by TNO Work & Employment in the Netherlands in close co-operation with a group of system-information suppliers across the European member states and Norway. The report contains an overall analysis of the monitoring systems, highlighting interesting elements and pointing

How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing?

Directory of Open Access Journals (Sweden)

Dylst P

2012-03-01

Full Text Available Generic medicines can generate larger savings to health care budgets when their use is supported by incentives on both the supply-side and the demand-side. Pharmacists’ remuneration is one factor influencing the dispensing of generic medicines.Objective: The aim of this article is to provide an overview of different pharmacist remuneration systems for generic medicines in Europe, with a view to exploring how pharmacist remuneration systems can contribute to generic medicine dispensing.Methods: Data were obtained from a literature review, a Master thesis in Pharmaceutical Care at the Catholic University of Leuven and a mailing sent to all members of the Pharmaceutical Group of the European Union with a request for information about the local remuneration systems of community pharmacists and the possible existence of reports on discounting practices.Results: Pharmacists remuneration in most European countries consists of the combination of a fixed fee per item and a certain percentage of the acquisition cost or the delivery price of the medicines. This percentage component can be fixed, regressive or capped for very high-cost medicines and acts as a disincentive for dispensing generic medicines. Discounting for generic medicines is common practice in several European countries but information on this practice tends to be confidential. Nevertheless, data for Belgium, France, the Netherlands and United Kingdom indicated that discounting percentages varied from 10% to 70% of the wholesale selling price.Conclusion: Pharmacists can play an important role in the development of a generic medicines market. Pharmacists should not be financially penalized for dispensing generic medicines. Therefore, their remuneration should move towards a fee-for-performance remuneration instead of a price-dependent reimbursement which is currently used in many European countries. Such a fee-for-performance remuneration system provides a stimulus for generic medicines

The medicinal plants of Chepan Mountain (Western Bulgaria)

Science.gov (United States)

Zahariev, Dimcho

2015-12-01

Bulgaria is one of the European countries with the greatest biodiversity, including biodiversity of medicinal plants. The object of this study is Chepan Mountain. It is located in Western Bulgaria and it is part of Balkan Mountain. On the territory of the Chepan Mountain (only 80 km2) we found 344 species of medicinal plants from 237 genera and 83 families. The floristic analysis indicates, that the most of the families and the genera are represented by a small number of inferior taxa. The hemicryptophytes dominate among the life forms with 49.71%. The biological types are represented mainly by perennial herbaceous plants (60.47%). There are 7 types of floristic elements divided in 27 groups. The largest percentage of species are of the European type (58.43%). Among the medicinal plants, there are two Balkan endemic species and 18 relic species. We described 23 species with protection statute. The anthropophytes among the medicinal plants are 220 species (63.95%).

US energy agency making progress

Science.gov (United States)

2017-07-01

The Advanced Research Projects Agency-Energy (ARPA-E) has the ability to make significant contributions to energy research but must be allowed time to do so, according to a report by the US National Academies of Sciences, Engineering and Medicine.

Medicinal plants of the Mapuche.

Science.gov (United States)

Houghton, P J; Manby, J

1985-03-01

A list of 136 plants used for medicinal purposes by the Mapuche Amerindians of Chile has been compiled. This is the first such list in English and is important due to the disappearance of Mapuche culture with increasing urbanisation. Some introduced plants have been incorporated into the traditional medicine of the Mapuche since the advent of European settlers but there is also a wealth of information about the uses of many indigenous species.

Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines.

Science.gov (United States)

Ruggieri, L; Giannuzzi, V; Baiardi, P; Bonifazi, F; Davies, E H; Giaquinto, C; Bonifazi, D; Felisi, M; Chiron, C; Pressler, R; Rabe, H; Whitaker, M J; Neubert, A; Jacqz-Aigrain, E; Eichler, I; Turner, M A; Ceci, A

2015-04-01

The European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly available sources have been consulted and a descriptive analysis has been performed. Twenty Research Consortia including 246 partners in 29 European and non-European countries were created (involving 129 universities or public-funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMA-Paediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres. Notwithstanding the EU contribution for each study is lower than similar publicly funded projects, and also considering the complexity of paediatric research, these projects are performing high-quality research and are progressing towards the increase of new paediatric medicines on the market. Private-public partnerships have been effectively implemented, providing a good example for future collaborative actions. Since these projects cover a limited number of off-patent drugs and many unmet therapeutic needs in paediatrics remain, it is crucial foreseeing new similar initiatives in forthcoming European funding programmes.

Preventive youth health care in 11 European countries: An exploratory analysis

NARCIS (Netherlands)

Wieske, R.C.N.; Nijnuis, M.G.; Carmiggelt, B.C.; Wagenaar-Fischer, M.M.; Boere-Boonekamp, M.M.

2012-01-01

Objective To systematically identify similarities and differences in the way preventive youth health care (YHC) is organized in 11 European countries. Method Questionnaire survey to EUSUHM (European Union for School and University Health and Medicine) representatives. Results The greatest

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Directory of Open Access Journals (Sweden)

Emel Mashaki Ceyhan

2018-01-01

Full Text Available Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP in order to facilitate the TITCK progress toward agency goals.Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA, Health Canada, Singapore's Health Science Authority (HSA, and the Saudi Arabia Food and Drug Administration (SFDA.Results: The TITCK performs a full review for all new active substance (NAS applications. Submission of a Certificate of Pharmaceutical product (CPP with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized.Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP process by sharing GMP inspection outcomes and certificates issued by

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore.

Science.gov (United States)

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Science.gov (United States)

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other

The management of clinical laboratories in Europe: a FESCC survey. Forum of the European Societies of Clinical Chemistry and Laboratory Medicine.

Science.gov (United States)

de Kieviet, Wim; Blaton, Victor; Kovacs, Gabor L; Palicka, Vladimir; Pulkki, Kari

2002-03-01

The professional duties of the specialists in clinical chemistry differ from country to country in Europe. One of the main goals of the Strategic Plan of the Forum of the European Societies of Clinical Chemistry and Laboratory Medicine (FESCC; IFCC-Europe) is to promote a high scientific and professional standard in the field of clinical chemistry and laboratory medicine in Europe. This can be stimulated by the knowledge of the local conditions in each country and by striving towards a strong and harmonised position in all the European countries. In order to enhance the knowledge of the managerial situation of the specialists in clinical chemistry in Europe, FESCC launched a survey in September 2000. This survey provides information about the position of the specialists in clinical chemistry in the various disciplines in the medical laboratories and in hospitals, and about the advisory tasks and the managerial education during the post-graduate training in clinical chemistry. Of the 35 FESCC member countries 33 have participated in the survey (94%). The results show a rather heterogeneous situation in Europe caused by the local historical developments, the differences in academic background and the relative numbers of private and physicians' office laboratories. Large differences exist between the European countries in the disciplines of laboratory medicine that are headed by a specialist in clinical chemistry. In the different countries the clinical chemistry laboratories are headed by specialists in clinical chemistry in between 20% and 100% of the laboratories. The haematology, immunology, microbiology, therapeutic drug monitoring, molecular biology and haemostasis laboratories and departments of blood banking are headed by specialists in clinical chemistry in between 0% and 100% of the laboratories. The responsibilities for the various managerial tasks of the specialists in clinical chemistry show no uniformity in Europe. In the majority of the countries the

Direct-to-consumer advertising of prescription drugs: European Commission persists in putting industry's interests first.

Science.gov (United States)

2013-01-01

In late September 2010, Members of the European Parliament (MEPs) issued their verdict on European Commission proposals aimed at lifting the ban on pharmaceutical companies communicating directly with the general public about prescription drugs. The MEPs were able to limit the scope of some of the more harmful aspects of these proposals, in particular by proposing that drug regulatory agencies should pre-screen the "information" produced by drug companies before it is made available to the public. In December 2010, faced with ongoing opposition from European Member States, the Commission appeared to back down, announcing that it was drawing up "amended proposals". They were publicly released in February 2012 but still leave the door open to direct-to-consumer advertising of prescription drugs, particularly "reminder advertising". As of 4 July 2012, the amended proposals had not yet been examined by Member States, thus obstructing the legislative process. Public health and management of the costs of social services for Member States are at stake. The Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB) urge Member States to continue to refuse to examine the Commission's proposals, and have drawn up concrete counterproposals that would enable the general public to obtain relevant health information.

Environmental Protection Agency - EPA Pub Central

Data.gov (United States)

U.S. Environmental Protection Agency — PubMed Central (PMC) is a full-text, online archive of journal literature operated by the National Library of Medicine. The EPA is using PMC to permanently preserve...

Off-Label Prescription of Genetically Modified Organism Medicines in Europe : Emerging Conflicts of Interest?

NARCIS (Netherlands)

Schagen, Frederik H. E.; Hoeben, Rob C.; Hospers, Geke A. P.

2014-01-01

Recently, the first human medicine containing a genetically modified organism (GMO medicine) was authorized for use in the European market. Just as any medicinal product, the market authorization for a GMO medicine contains a precise description of the therapeutic use for which the medicinal product

The American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, and the Asian Australasian Federation of Pain Societies Joint Committee recommendations for education and training in ultrasound-guided interventional pain procedures.

Science.gov (United States)

Narouze, Samer N; Provenzano, David; Peng, Philip; Eichenberger, Urs; Lee, Sang Chul; Nicholls, Barry; Moriggl, Bernhard

2012-01-01

The use of ultrasound in pain medicine for interventional axial, nonaxial, and musculoskeletal pain procedures is rapidly evolving and growing. Because of the lack of specialty-specific guidelines for ultrasonography in pain medicine, an international collaborative effort consisting of members of the Special Interest Group on Ultrasonography in Pain Medicine from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, and the Asian Australasian Federation of Pain Societies developed the following recommendations for education and training in ultrasound-guided interventional pain procedures. The purpose of these recommendations is to define the required skills for performing ultrasound-guided pain procedures, the processes for appropriate education, and training and quality improvement. Training algorithms are outlined for practice- and fellowship-based pathways. The previously published American Society of Regional Anesthesia and Pain Medicine and European Society of Regional Anaesthesia and Pain Therapy education and teaching recommendations for ultrasound-guided regional anesthesia served as a foundation for the pain medicine recommendations. Although the decision to grant ultrasound privileges occurs at the institutional level, the committee recommends that the training guidelines outlined in this document serve as the foundation for educational training and the advancement of the practice of ultrasonography in pain medicine.

Precision medicine in patients with allergic diseases: Airway diseases and atopic dermatitis-PRACTALL document of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology.

Science.gov (United States)

Muraro, Antonella; Lemanske, Robert F; Hellings, Peter W; Akdis, Cezmi A; Bieber, Thomas; Casale, Thomas B; Jutel, Marek; Ong, Peck Y; Poulsen, Lars K; Schmid-Grendelmeier, Peter; Simon, Hans-Uwe; Seys, Sven F; Agache, Ioana

2016-05-01

In this consensus document we summarize the current knowledge on major asthma, rhinitis, and atopic dermatitis endotypes under the auspices of the PRACTALL collaboration platform. PRACTALL is an initiative of the European Academy of Allergy and Clinical Immunology and the American Academy of Allergy, Asthma & Immunology aiming to harmonize the European and American approaches to best allergy practice and science. Precision medicine is of broad relevance for the management of asthma, rhinitis, and atopic dermatitis in the context of a better selection of treatment responders, risk prediction, and design of disease-modifying strategies. Progress has been made in profiling the type 2 immune response-driven asthma. The endotype driven approach for non-type 2 immune response asthma, rhinitis, and atopic dermatitis is lagging behind. Validation and qualification of biomarkers are needed to facilitate their translation into pathway-specific diagnostic tests. Wide consensus between academia, governmental regulators, and industry for further development and application of precision medicine in management of allergic diseases is of utmost importance. Improved knowledge of disease pathogenesis together with defining validated and qualified biomarkers are key approaches to precision medicine. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Radionuclides for nuclear medicine: a nuclear physicists' view

Czech Academy of Sciences Publication Activity Database

Cantone, M.; Haddad, F.; Harissopoulos, S.; Jensen, M.; Jokinen, A.; Koster, U.; Lebeda, Ondřej; Ponsard, B.; Ratzinger, U.; Stora, T.; Tarkanyi, F.; Van Duppen, P.

2013-01-01

Roč. 40, 2 Supplement (2013), S257-S257 ISSN 1619-7070. [Annual Congress of the European Association of Nuclear Medicine (EANM). 19.10.2013-23.10.2013, Lyon] Institutional support: RVO:61389005 Keywords : nuclear physics for medicine * EANM * medical radionuclides Subject RIV: BG - Nuclear, Atomic and Molecular Physics, Colliders

[Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].

Science.gov (United States)

Enzmann, Harald; Broich, Karl

2013-01-01

For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate

Expertise and Power: Agencies Operating in Complex Environments

Directory of Open Access Journals (Sweden)

Anthony R. Zito

2015-03-01

Full Text Available This contribution investigates the strategies that environmental agencies develop to enhance their policy autonomy, in order to fulfil their organisational missions for protecting the environment. This article asks whether there are particular strategic moves that an agency can make to augment this policy autonomy in the face of the principals. Critiquing principal agent theory, it investigates the evolution of three environmental agencies (the European Environment Agency, the England and Wales Environment Agency and the United States Environmental Protection Agency, focusing on the case study of climate change. The contribution examines how the agencies influence environmental policy on domestic, regional and global levels, with a special focus on the principals that constrain agency autonomy. A greater focus on different multi-level contexts, which the three agencies face, may create other possible dynamics and opportunities for agency strategies. Agencies can use particular knowledge, network and alliance building to strengthen their policy/political positions.

Comprehensive Auditing in Nuclear Medicine Through the International Atomic Energy Agency Quality Management Audits in Nuclear Medicine Program. Part 2: Analysis of Results.

Science.gov (United States)

Dondi, Maurizio; Torres, Leonel; Marengo, Mario; Massardo, Teresa; Mishani, Eyal; Van Zyl Ellmann, Annare; Solanki, Kishor; Bischof Delaloye, Angelika; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Ordonez, Felix Barajas; Paez, Diana; Pascual, Thomas

2017-11-01

The International Atomic Energy Agency has developed a program, named Quality Management Audits in Nuclear Medicine (QUANUM), to help its Member States to check the status of their nuclear medicine practices and their adherence to international reference standards, covering all aspects of nuclear medicine, including quality assurance/quality control of instrumentation, radiopharmacy (further subdivided into levels 1, 2, and 3, according to complexity of work), radiation safety, clinical applications, as well as managerial aspects. The QUANUM program is based on both internal and external audits and, with specifically developed Excel spreadsheets, it helps assess the level of conformance (LoC) to those previously defined quality standards. According to their level of implementation, the level of conformance to requested standards; 0 (absent) up to 4 (full conformance). Items scored 0, 1, and 2 are considered non-conformance; items scored 3 and 4 are considered conformance. To assess results of the audit missions performed worldwide over the last 8 years, a retrospective analysis has been run on reports from a total of 42 audit missions in 39 centers, three of which had been re-audited. The analysis of all audit reports has shown an overall LoC of 73.9 ± 8.3% (mean ± standard deviation), ranging between 56.6% and 87.9%. The highest LoC has been found in the area of clinical services (83.7% for imaging and 87.9% for therapy), whereas the lowest levels have been found for Radiopharmacy Level 2 (56.6%); Computer Systems and Data Handling (66.6%); and Evaluation of the Quality Management System (67.6%). Prioritization of non-conformances produced a total of 1687 recommendations in the final audit report. Depending on the impact on safety and daily clinical activities, they were further classified as critical (requiring immediate action; n = 276; 16% of the total); major (requiring action in relatively short time, typically from 3 to 6 months; n = 604

Scandinavian Fellowship for Oral Pathology and Oral Medicine

DEFF Research Database (Denmark)

Kragelund, Camilla; Reibel, J; Hietanen, J

2012-01-01

as new approaches, treatments and diagnostic possibilities develop. Likewise, the role of the dentist in the community changes and may vary in different countries. As members of the Scandinavian Fellowship for Oral Pathology and Oral Medicine and subject representatives of oral pathology and oral......In Scandinavia, as in many European countries, most patients consult their general dentist once a year or more. This gives the dentist a unique opportunity and an obligation to make an early diagnosis of oral diseases, which is beneficial for both the patient and the society. Thus, the dentist must...... medicine, we feel obliged to contribute to the discussion of how the guidelines of the dental curriculum support the highest possible standards of dental education. This article is meant to delineate a reasonable standard of oral pathology and oral medicine in the European dental curriculum and to guide...

Nuclear medicine in developing nations

International Nuclear Information System (INIS)

Nofal, M.M.

1985-01-01

Agency activities in nuclear medicine are directed towards effectively applying techniques to the diagnosis and management of patients attending nuclear medicine units in about 60 developing countries. A corollary purpose is to use these techniques in investigations related to control of parasitic diseases distinctive to some of these countries. Through such efforts, the aim is to improve health standards through better diagnosis, and to achieve a better understanding of disease processes as well as their prevention and management. Among general trends observed for the region: Clinical nuclear medicine; Radiopharmaceuticals; Monoclonal antibodies; Radioimmunoassay (RIA); Nuclear imaging

European integration in crisis? Of supranational integration, hegemonic projects and domestic politics

Science.gov (United States)

Bulmer, Simon; Joseph, Jonathan

2015-01-01

The European Union is facing multiple challenges. Departing from mainstream theory, this article adopts a fresh approach to understanding integration. It does so by taking two theoretical steps. The first introduces the structure–agency debate in order to make explicit the relationship between macro-structures, the institutional arrangements at European Union level and agency. The second proposes that the state of integration should be understood as the outcome of contestation between competing hegemonic projects that derive from underlying social processes and that find their primary expression in domestic politics. These two steps facilitate an analysis of the key areas of contestation in the contemporary European Union, illustrated by an exploration of the current crisis in the European Union, and open up the development of an alternative, critical, theory of integration. PMID:29708125

Neutron use in nuclear medicine

Energy Technology Data Exchange (ETDEWEB)

Guidez, J.; May, R.; Moss, R. [HFR-Unit, European Commission, IAM, Petten (Netherlands); Askienazy, S. [Departement Central de Medicine Nucleaire et Biophysique, Saint Antoine Hospital, Paris (France); Hildebrand, J. [Neurology Department, Erasmus Hospital, Brussels (Belgium)

1999-07-01

Neutrons produced by research reactors are being used in nuclear medicine and other medical applications in several ways. The High Flux Reactor (HFR) based in Petten (The Netherlands), owned by the European Commission, has been working increasingly in this field of health care for the European citizen. On the basis of this experience, a survey has been carried out on the main possibilities of neutrons used in nuclear medicine. The most important and most well known is the production of radioisotopes for diagnosis and therapy. Ten million patients receive nuclear medicine in Europe each year, with more than 8 million made with the products issued from research reactors. The survey of the market and the techniques (cyclotron, PET) shows that this market will continue to increase in the future. The direct use of reactors in medicine is actually made by the Boron Neutron capture Therapy (BNCT) for the treatment of glioblastoma, which kills about 15.000 people in Europe each year. For this promising technique, HFR is the most advanced for experimental possibilities and treatment studies. Medical research is also made in other promising fields: the use beam tubes for characterizing of prostheses and bio-medical materials, alpha-immuno therapy products, new types of radioisotopes, new types of illness to be treated by BNCT, etc. (author)

Neutron use in nuclear medicine

International Nuclear Information System (INIS)

Guidez, J.; May, R.; Moss, R.; Askienazy, S.; Hildebrand, J.

1999-01-01

Neutrons produced by research reactors are being used in nuclear medicine and other medical applications in several ways. The High Flux Reactor (HFR) based in Petten (The Netherlands), owned by the European Commission, has been working increasingly in this field of health care for the European citizen. On the basis of this experience, a survey has been carried out on the main possibilities of neutrons used in nuclear medicine. The most important and most well known is the production of radioisotopes for diagnosis and therapy. Ten million patients receive nuclear medicine in Europe each year, with more than 8 million made with the products issued from research reactors. The survey of the market and the techniques (cyclotron, PET) shows that this market will continue to increase in the future. The direct use of reactors in medicine is actually made by the Boron Neutron capture Therapy (BNCT) for the treatment of glioblastoma, which kills about 15.000 people in Europe each year. For this promising technique, HFR is the most advanced for experimental possibilities and treatment studies. Medical research is also made in other promising fields: the use beam tubes for characterizing of prostheses and bio-medical materials, alpha-immuno therapy products, new types of radioisotopes, new types of illness to be treated by BNCT, etc. (author)

Quality control in nuclear medicine

International Nuclear Information System (INIS)

Kostadinova, I.

2007-01-01

Nuclear medicine comprises diagnosis and therapy of the diseases with radiopharmaceuticals. The ambition of all specialists in our country is their activity to reach European standards. In this connection, a Commission for external audit was formed to evaluate the quality of work in the centers of nuclear medicine. This Commission create a long-lasting programme based on the objective European criteria and the national standard of nuclear medicine, having in mind to increase quality of the work and the expert evaluation of activity in every center. The program comprises measures for quality control of instrumentation, radiopharmaceuticals, performed investigations, obtained results and the whole organization from the receiving of the isotopes to the results of the patients. The ambition is most of the centers to fulfill the requirements. As a conclusion it could be said that not only the quality of everyday nuclear medicine work is enough to increase the prestige of the specialty. It is also necessary we to have understanding expert and financial support from corresponding institutions, incl. Ministry of health for a delivery of a new, contemporary instrumentation with new possibilities. Thus it would be possible Bulgarian patients to reach the high technology apparatuses for an early functional diagnosis of the diseases and optimal treatment, which possibility have the patients from the developed countries. (author)

Readability Analysis of the Package Leaflets for Biological Medicines Available on the Internet Between 2007 and 2013: An Analytical Longitudinal Study.

Science.gov (United States)

Piñero-López, María Ángeles; Modamio, Pilar; Lastra, Cecilia F; Mariño, Eduardo L

2016-05-25

The package leaflet included in the packaging of all medicinal products plays an important role in the transmission of medicine-related information to patients. Therefore, in 2009, the European Commission published readability guidelines to try to ensure that the information contained in the package leaflet is understood by patients. The main objective of this study was to calculate and compare the readability levels and length (number of words) of the package leaflets for biological medicines in 2007, 2010, and 2013. The sample of this study included 36 biological medicine package leaflets that were downloaded from the European Medicines Agency website in three different years: 2007, 2010, and 2013. The readability of the selected package leaflets was obtained using the following readability formulas: SMOG grade, Flesch-Kincaid grade level, and Szigriszt's perspicuity index. The length (number of words) of the package leaflets was also measured. Afterwards, the relationship between these quantitative variables (three readability indexes and length) and categorical (or qualitative) variables were analyzed. The categorical variables were the year when the package leaflet was downloaded, the package leaflet section, type of medicine, year of authorization of biological medicine, and marketing authorization holder. The readability values of all the package leaflets exceeded the sixth-grade reading level, which is the recommended value for health-related written materials. No statistically significant differences were found between the three years of study in the readability indexes, although differences were observed in the case of the length (P=.002), which increased over the study period. When the relationship between readability indexes and length and the other variables was analyzed, statistically significant differences were found between package leaflet sections (Preadability indexes (SMOG grade and Flesch-Kincaid grade level: r(2)=.92; SMOG grade and Szigriszt

Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries.

Science.gov (United States)

Angelis, Aris; Lange, Ansgar; Kanavos, Panos

2018-01-01

Although health technology assessment (HTA) systems base their decision making process either on economic evaluations or comparative clinical benefit assessment, a central aim of recent approaches to value measurement, including value based assessment and pricing, points towards the incorporation of supplementary evidence and criteria that capture additional dimensions of value. To study the practices, processes and policies of value-assessment for new medicines across eight European countries and the role of HTA beyond economic evaluation and clinical benefit assessment. A systematic (peer review and grey) literature review was conducted using an analytical framework examining: (1) 'Responsibilities and structure of HTA agencies'; (2) 'Evidence and evaluation criteria considered in HTAs'; (3) 'Methods and techniques applied in HTAs'; and (4) 'Outcomes and implementation of HTAs'. Study countries were France, Germany, England, Sweden, Italy, Netherlands, Poland and Spain. Evidence from the literature was validated and updated through two rounds of feedback involving primary data collection from national experts. All countries assess similar types of evidence; however, the specific criteria/endpoints used, their level of provision and requirement, and the way they are incorporated (e.g. explicitly vs. implicitly) varies across countries, with their relative importance remaining generally unknown. Incorporation of additional 'social value judgements' (beyond clinical benefit assessment) and economic evaluation could help explain heterogeneity in coverage recommendations and decision-making. More comprehensive and systematic assessment procedures characterised by increased transparency, in terms of selection of evaluation criteria, their importance and intensity of use, could lead to more rational evidence-based decision-making, possibly improving efficiency in resource allocation, while also raising public confidence and fairness.

Clinical evidence for orphan medicinal products-a cause for concern?

Science.gov (United States)

Picavet, Eline; Cassiman, David; Hollak, Carla E; Maertens, Johan A; Simoens, Steven

2013-10-16

The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are too low. Therefore, the aim of this study was to quantitatively evaluate the characteristics and quality of clinical evidence that is presented for OMPs to obtain marketing authorization in Europe, using the new and validated COMPASS tool. We quantitatively assessed the characteristics and quality of clinical evidence of the pivotal studies of 64 OMPs as described in the European Public Assessment Report and/or the Scientific Discussion document prepared by the Committee for Human Medicinal Products of the EMA. The 64 OMPs were altogether authorized for 78 orphan indications, for which 117 studies were identified as 'pivotal' or 'main' studies. In approximately two thirds of the studies, the allocation was randomized (64.8%) and a control arm was used (68.5%). Half of the studies applied some type of blinding. Only a minority (26.9%) of the studies included a Quality-of-Life (QoL) related endpoint, of which a third claim an improvement in QoL. Upon analyzing the quality of reporting, we found that some aspects (i.e. the endpoints, the sampling criteria, and the interventions) are well described, whereas other items (i.e. a description of the patients and of potential biases) are not reported for all studies. In conclusion, the pivotal studies that are the basis for marketing authorization of OMPs are a cause for concern, as they exhibit methodological flaws i.e. the lack of QoL-related endpoints as outcome, lack of blinding in the study design and the use of surrogate endpoints. Additionally, there are shortcomings in the reporting of those studies that complicate the interpretation. A more demanding regulatory process for OMPs is

ACCOUNTING OF AGRICULTURAL ACTIVITIES AND EUROPEAN FUNDS

Directory of Open Access Journals (Sweden)

Daniel Petru VARTEIU

2017-12-01

Full Text Available The economical operations developed by the beneficiaries of European funds projects, are registered in accounting, based on justifying documents, in accordance with the national and international legislation in effect. The beneficiaries of European funds projects may be organized starting from the simplest form of organisation, which takes the form of self – employed person (SEP till the most complex form of organisation such as trading companies (T.C.. The Romanian institutions which finance agricultural activities are Ministry of Agriculture and Rural Development (M.A.R.D which subordinates Rural Investment Finance Agency (R.I.F.A and Payment and Intervention Agency in Agriculture (P.I.A.A. The Ministry of Agriculture and Rural Development has an authority role, of management (AM for the National Rural Development Program (N.R.D.P and for the Fisheries Operational Program (F.O.P. The funds obtained from the European Union and from Romanian institutions for the development of agricultural activities are registered in accounting as grants, in the category of grants afferent to assets or afferent to incomes.

75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

Science.gov (United States)

2010-01-28

...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory... Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl...

Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.

Science.gov (United States)

Santoro, Aniello; Genov, Georgy; Spooner, Almath; Raine, June; Arlett, Peter

2017-10-01

This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, underlying principles, components and drivers for future change. At its core, the Pharmacovigilance Risk Assessment Committee is responsible for assessing all aspects of the risk management of medicinal products, thus ensuring that medicines approved for the European Union market are optimally used by maximising their benefits and minimising risks. The main objectives of the system are to promote and protect public health by supporting the availability of medicines including those that fulfil previously unmet medical needs, and reducing the burden of adverse drug reactions. These are achieved through a proactive, risk proportionate and patient-centred approach, with high levels of transparency and engagement of civil society. In the European Union, pharmacovigilance is now fully integrated into the life cycle of medicinal products, with the planning of pharmacovigilance activities commencing before a medicine is placed on the market, and companies encouraged to start planning very early in development for high-innovation products. After authorisation, information on the safety of medicines continues to be obtained through a variety of sources, including spontaneous reports of adverse drug reactions or monitoring real-world data. Finally, the measurement of the impact of pharmacovigilance activities, auditing and inspections, as well as capacity building ensure that the system undergoes continuous improvement and can always rely on the best methodologies to safeguard public health.

The Helsinki Declaration on Patient Safety in Anesthesiology: a way forward with the European Board and the European Society of Anesthesiology.

Science.gov (United States)

Petrini, F; Solca, M; De Robertis, E; Peduto, V A; Pasetto, A; Conti, G; Antonelli, M; Pelosi, P

2010-11-01

Anesthesiology, which includes anaesthesia, perioperative care, intensive care medicine, emergency medicine and pain therapy, is acknowledged as the leading medical specialty in addressing issues of patient safety, but there is still a long way to go. Several factors pose hazards in Anesthesiology, like increasingly older and sicker patients, more complex surgical interventions, more pressure on throughput, as well as new drugs and devices. To better design educational and research strategies to improve patient safety, the European Board of Anesthesiology (EBA) and the European Society of Anesthesiology (ESA) have produced a blueprint for patient safety in Anesthesiology. This document, to be known as the Helsinki Declaration on Patient Safety in Anesthesiology, was endorsed together with the World Health Organization (WHO), the World Federation of Societies of Anesthesiologists (WFSA), and the European Patients' Federation (EPF) at the Euroanaesthesia meeting in Helsinki in June 2010. It was signed by several Presidents of National Anesthesiology Societies as well as other stakeholders. The Helsinki Declaration on Patient Safety in Anesthesiology represents a shared European view of what is necessary to improve patient safety, recommending practical steps that all anesthesiologists can include in their own clinical practice. The Italian Society of Anaesthesia, Analgesia, Reanimation and Intensive Care (SIAARTI) is looking forward to continuing work on "patient safety" issues in Europe, and to cooperating with the ESA in the best interest of European patients.

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Hungary and Malta

International Nuclear Information System (INIS)

2008-01-01

Article 23(a) of the Agreement, and the Protocol thereto, between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) provides that the Agreement shall come into force for non-nuclear-weapon States Party to NPT which become members of the European Atomic Energy Community upon: (i) Notification to the Agency by the State concerned that its procedures with respect to the coming into force of the Agreement have been completed; and (ii) Notification to the Agency by the European Atomic Energy Community that it is in a position to apply its safeguards in respect of that State for the purposes of the Agreement. The Agreement and the Protocol thereto, which came into force for the above-mentioned original signatories on 21 February 1977, have also entered into force for Austria, Estonia, Finland, Greece, Poland, Portugal, Spain, Slovakia, Slovenia and Sweden

Nurse prescribing of medicines in Western European and Anglo-Saxon countries: a systematic review of the literature.

Science.gov (United States)

Kroezen, Marieke; van Dijk, Liset; Groenewegen, Peter P; Francke, Anneke L

2011-05-27

A growing number of countries are introducing some form of nurse prescribing. However, international reviews concerning nurse prescribing are scarce and lack a systematic and theoretical approach. The aim of this review was twofold: firstly, to gain insight into the scientific and professional literature describing the extent to and the ways in which nurse prescribing has been realised or is being introduced in Western European and Anglo-Saxon countries; secondly, to identify possible mechanisms underlying the introduction and organisation of nurse prescribing on the basis of Abbott's theory on the division of professional labor. A comprehensive search of six literature databases and seven websites was performed without any limitation as to date of publication, language or country. Additionally, experts in the field of nurse prescribing were consulted. A three stage inclusion process, consisting of initial sifting, more detailed selection and checking full-text publications, was performed independently by pairs of reviewers. Data were synthesized using narrative and tabular methods. One hundred and twenty-four publications met the inclusion criteria. So far, seven Western European and Anglo-Saxon countries have implemented nurse prescribing of medicines, viz., Australia, Canada, Ireland, New Zealand, Sweden, the UK and the USA. The Netherlands and Spain are in the process of introducing nurse prescribing. A diversity of external and internal forces has led to the introduction of nurse prescribing internationally. The legal, educational and organizational conditions under which nurses prescribe medicines vary considerably between countries; from situations where nurses prescribe independently to situations in which prescribing by nurses is only allowed under strict conditions and supervision of physicians. Differences between countries are reflected in the jurisdictional settlements between the nursing and medical professions concerning prescribing. In some

75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting

Science.gov (United States)

2010-08-26

...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...

Defence electro-optics: European perspective

Science.gov (United States)

Hartikainen, Jari

2011-11-01

In 2009 the United States invested in defence R&T 3,6 times and in defence research and development 6,8 times as much as all member states of the European Defence Agency (EDA) combined while the ratio in the total defence expenditure was 2,6 in the US' favour. The European lack of investments in defence research and development has a negative impact on the competitiveness of European defence industry and on the European non-dependence. In addition, the efficiency of investment is reduced due to duplication of work in different member states. The Lisbon Treaty tasks EDA to support defence technology research, and coordinate and plan joint research activities and the study of technical solutions meeting future operational needs. This paper gives an overview how EDA meets the challenge of improving the efficiency of European defence R&T investment with an emphasis on electro-optics and describes shortly the ways that governmental and industrial partners can participate in the EDA cooperation. Examples of joint R&T projects addressing electro-optics are presented.

Current Trends in European Quality Assurance. ENQA Workshop Report 8

Science.gov (United States)

Bozo, Dhurata; Damian, Radu; Gonzalez, Cecilia de la Rosa; Helle, Emmi; Imoda, Franco; Kohler, Alexander; Papazoglou, Vassilios J.; Dalmau, Gemma Rauret; Shopov, Todor

2009-01-01

The present report is a product of two ENQA (European Association for Quality Assurance in Higher Education) seminars, held in 2007, on current trends in European Quality Assurance. The first seminar, hosted by the Bulgarian National Evaluation and Accreditation Agency (NEAA), examined the situation in South-Eastern Europe. The second seminar…

Studying use and risks of medicines in children: a European approach

NARCIS (Netherlands)

S. de Bie (Sandra)

2013-01-01

textabstractIn recent years there has been increasing awareness on the gap in knowledge on the safety and efficacy of medicines used in children. The work as described in this thesis is based on large observational studies across Europe and aimed to study the use and risks of medicines in children

ENABLE 2017, the First EUROPEAN PhD and Post-Doc Symposium. Session 4: From Discovery to Cure: The Future of Therapeutics

Directory of Open Access Journals (Sweden)

Gianmarco Di Mauro

2018-05-01

Full Text Available The EUROPEAN ACADEMY FOR BIOMEDICAL SCIENCE (ENABLE is an initiative funded by the European Union Horizon 2020 program involving four renowned European Research Institutes (Institute for Research in Biomedicine—IRB Barcelona, Spain; Radboud Institute for Molecular Life Sciences—RIMLS, the Netherlands; Novo Nordisk Foundation Center for Protein Research—NNF CPR, Denmark; European School of Molecular Medicine—SEMM, Italy and an innovative science communication agency (Scienseed. With the aim of promoting biomedical science of excellence in Europe, ENABLE organizes an annual three-day international event. This gathering includes a top-level scientific symposium bringing together leading scientists, PhD students, and post-doctoral fellows; career development activities supporting the progression of young researchers and fostering discussion about opportunities beyond the bench; and outreach activities stimulating the interaction between science and society. The first European PhD and Postdoc Symposium, entitled “Breaking Down Complexity: Innovative Models and Techniques in Biomedicine”, was hosted by the vibrant city of Barcelona. The scientific program of the conference was focused on the most recent advances and applications of modern techniques and models in biomedical research and covered a wide range of topics, from synthetic biology to translational medicine. Overall, the event was a great success, with more than 200 attendees from all over Europe actively participating in the symposium by presenting their research and exchanging ideas with their peers and world-renowned scientists.

Cardiovascular nuclear medicine and MRI

International Nuclear Information System (INIS)

Reiber, J.H.C.; Wall, E.E. van der

1992-01-01

This book is based on a meeting of the Working Group on Nuclear Cardiology, which held March 22-23,1991 under the auspices of the European Society of Cardiology and the Interuniversity Cardiology Institute of the Netherlands, and on the Second International Symposium on Computer Applications in Nuclear Medicine and Cardiac Magnetic Resonance Imaging, which was held March 20-22,1991 in Rotterdam, the Netherlands. It covers almost every aspect of quantitative cardio-vascular nuclear medicine and magnetic resonance imaging. The main topics are: single photon emission computed tomography (technical aspects); new development in cardiovascular nuclear medicine; advances in cardiovascular imaging; cardiovascular clinical applications; and cardiac magnetic resonance imaging. (A.S.). refs.; figs.; tabs

Implementing the European Marine Strategy Framework Directive: Scientific challenges and opportunities

Science.gov (United States)

Newton, Alice; Borja, Angel; Solidoro, Cosimo; Grégoire, Marilaure

2015-10-01

The Marine Strategy Framework Directive (MSFD; EC, 2008) is an ambitious European policy instrument that aims to achieve Good Environmental Status (GES) in the 5,720,000 km2 of European seas by 2020, using an Ecosystem Approach. GES is to be assessed using 11 descriptors and up to 56 indicators (European Commission, 2010), and the goal is for clean, healthy and productive seas that are the basis for marine-based development, known as Blue-Growth. The MSFD is one of many policy instruments, such as the Water Framework Directive, the Common Fisheries Policy and the Habitats Directive that, together, should result in "Healthy Oceans and Productive Ecosystems - HOPE". Researchers working together with stakeholders such as the Member States environmental agencies, the European Environmental Agency, and the Regional Sea Conventions, are to provide the scientific knowledge basis for the implementation of the MSFD. This represents both a fascinating challenge and a stimulating opportunity.

Trends and Challenges of Traditional Medicine in Africa | Abdullahi ...

African Journals Online (AJOL)

Prior to the introduction of cosmopolitan medicine, traditional medicine used to be the dominant medical system available to millions of people in Africa in both rural and urban communities. However, the arrival of the Europeans marked a significant turning point in the history of this age-long tradition and culture. This paper ...

Nuclear medicine in cardiology: a position paper for an open debate

International Nuclear Information System (INIS)

Ell, P.J.; Bourguignon, M.H.; Pauwels, E.K.J.; Martin-Comin, J.; Roo, M. de; Dige-Petersen, H.

1995-01-01

The European Union of Medical Specialities (EUMS) is in the process of collecting data on the practice of nuclear medicine in cardiology in Europe in the different European national territories. A report on this practice is expected to become available shortly. (orig.)

[Safety monitoring of cell-based medicinal products (CBMPs)].

Science.gov (United States)

Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

2015-11-01

Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability.

Science.gov (United States)

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2015-02-01

Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.

The 23rd Annual Meeting of the European Tissue Repair Society (ETRS) in Reims, France

DEFF Research Database (Denmark)

Von den Hoff, Johannes W; Ågren, Sven Per Magnus; Coulomb, Bernard

2014-01-01

The 23rd Annual Meeting of the European Tissue Repair Society, Reims, France, October 23 to 25, 2013 focused on tissue repair and regenerative medicine covering topics such as stem cells, biomaterials, tissue engineering, and burns.......The 23rd Annual Meeting of the European Tissue Repair Society, Reims, France, October 23 to 25, 2013 focused on tissue repair and regenerative medicine covering topics such as stem cells, biomaterials, tissue engineering, and burns....

Cross-country variation in medicines use; a pharmaceutical system perspective

NARCIS (Netherlands)

Hoebert, J.M.

2013-01-01

Access to effective and affordable medicines (medical care) is considered an equitable right for all (European) citizens. Ensuring access to medical care is a challenge for governments and health care systems across the world. Choices need to be made about which medicine can be used and in what

A hard lesson for Europeans: the ASEAN CDC.

Science.gov (United States)

Tibayrenc, Michel

2005-06-01

Despite the growing threat of major pandemics, the European Union is planning no more than a meager surveillance agency staffed with 70 people on the 2007 horizon: the new European Centre for Disease Control. I argue that an effective structure should be much larger and include a strong research activity. Asian countries, inspired by the US CDC, are now taking this concept in hand and creating an ASEAN Center For Disease Control, with sophisticated laboratory facilities to be included. This is a tough lesson for us Europeans, and our avarice in this domain could have tragic consequences in the future.

Scandinavian Fellowship for Oral Pathology and Oral Medicine : statement on oral pathology and oral medicine in the European Dental Curriculum

NARCIS (Netherlands)

Kragelund, C.; Reibel, J.; Hadler-Olsen, E. S.; Hietanen, J.; Johannessen, A. C.; Kenrad, B.; Nylander, K.; Puranen, M.; Rozell, B.; Salo, T.; Syrjanen, S.; Soland, T. M.; van der Waal, I.; van der Wal, J. E.; Warfvinge, G.

Background: For many years, dentists have migrated between the Scandinavian countries without an intentionally harmonized dental education. The free movement of the workforce in the European Union has clarified that a certain degree of standardization or harmonization of the European higher

Scandinavian Fellowship for Oral Pathology and Oral Medicine: statement on oral pathology and oral medicine in the European Dental Curriculum

NARCIS (Netherlands)

Kragelund, C.; Reibel, J.; Hadler-Olsen, E.S.; Hietanen, J.; Johannessen, A.C.; Kenrad, B.; Nylander, K.; Puranen, M.; Rozell, B.; Salo, T.; Syrjänen, S.; Soland, T.M.; van der Waal, I.; van der Wal, J.E.; Warfvinge, G.

2010-01-01

Background:  For many years, dentists have migrated between the Scandinavian countries without an intentionally harmonized dental education. The free movement of the workforce in the European Union has clarified that a certain degree of standardization or harmonization of the European higher

Precision or Personalized Medicine for Cancer Chemotherapy: Is there a Role for Herbal Medicine.

Science.gov (United States)

Wang, Zhijun; Liu, Xuefeng; Ho, Rebecca Lucinda Ka Yan; Lam, Christopher Wai Kei; Chow, Moses Sing Sum

2016-07-07

Although over 100 chemotherapeutic agents are currently available for the treatment of cancer patients, the overall long term clinical benefit is disappointing due to the lack of effectiveness or severe side effects from these agents. In order to improve the therapeutic outcome, a new approach called precision medicine or personalized medicine has been proposed and initiated by the U.S. National Institutes of Health. However, the limited availability of effective medications and the high cost are still the major barriers for many cancer patients. Thus alternative approaches such as herbal medicines could be a feasible and less costly option. Unfortunately, scientific evidence for the efficacy of a majority of herbal medicines is still lacking and their development to meet FDA approval or other regulatory agencies is a big challenge. However, herbal medicines may be able to play an important role in precision medicine or personalized medicine. This review will focus on the existing and future technologies that could speed the development of herbal products for treatment of resistant cancer in individual patients. Specifically, it will concentrate on reviewing the phenotypic (activity based) rather than genotypic (mechanism based) approach to develop herbal medicine useful for personalized cancer chemotherapy.

Gender perspective in occupational medicine and workplace risk assessment: state of the art and research agenda.

Science.gov (United States)

Protano, C; Magrini, A; Vitali, M; Sernia, S

2016-01-01

The aim of this study was to investigate the current situation and the research agenda in the field of gender differences, both generically in the occupational settings and in the specific activity of risk assessment. Gender is a key determinant of health; the evaluation of documents and scientific literature shows increasing attention to a gender oriented approach, as demonstrated by the development of Gender Medicine, actually cross-oriented in all medical specialties, the publication of books dedicated to this topic and the birth of "ad hoc" new scientific societies and journals. Even today, however, the gender differences are not considered as they should in the context of health disciplines, including occupational medicine. In this respect, in fact, the critical issues to be overcome are numerous, such as the phenomena of "segregation", the exposure to risk factors and their effects, related also to non-professional, socio-cultural features that differentiate male and female workers. All these factors can lead to situations of inequality in health. In fact, the European directives on safety at work repeatedly highlight the attention to gender differences in prevention, assessment and management of risks. In this regard, the European Agency for Safety and Health at Work advocates an approach "more sensitive" to gender in all the processes of assessment and risk management, from the research of all potential sources of risk to the decision-making processes, in order to address the prevention of risks in a holistic manner.

Agreement between the French Republic, the European Atomic Energy Community and the International Atomic Energy Agency for the application of safeguards in connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Caribbean

International Nuclear Information System (INIS)

2008-01-01

The text of the Agreement (and the Protocols thereto) between the French Republic, the European Atomic Energy Community and the International Atomic Energy Agency for the Application of Safeguards in Connection with the Treaty for the Prohibition of Nuclear Weapons in Latin America and the Caribbean is reproduced in this document for the information of all Members. The Board of Governors approved the Agreement on 11 June 1998. It was signed in Vienna on 21 March 2000 by the representative of the Government of the French Republic and the Director General of the IAEA, and on 26 September 2000 by the representative of the European Atomic Energy Community. Pursuant to Article 23 of the Agreement, the Agreement entered into force on 26 October 2007, one month after the Agency has received notification from both France and the European Atomic Energy Community that their respective internal requirements for entry into force have been met. Pursuant to Article II of the Protocols, the Protocols entered into force on the same date

The European Hematology Association Roadmap for European Hematology Research: a consensus document.

Science.gov (United States)

Engert, Andreas; Balduini, Carlo; Brand, Anneke; Coiffier, Bertrand; Cordonnier, Catherine; Döhner, Hartmut; de Wit, Thom Duyvené; Eichinger, Sabine; Fibbe, Willem; Green, Tony; de Haas, Fleur; Iolascon, Achille; Jaffredo, Thierry; Rodeghiero, Francesco; Salles, Gilles; Schuringa, Jan Jacob

2016-02-01

The European Hematology Association (EHA) Roadmap for European Hematology Research highlights major achievements in diagnosis and treatment of blood disorders and identifies the greatest unmet clinical and scientific needs in those areas to enable better funded, more focused European hematology research. Initiated by the EHA, around 300 experts contributed to the consensus document, which will help European policy makers, research funders, research organizations, researchers, and patient groups make better informed decisions on hematology research. It also aims to raise public awareness of the burden of blood disorders on European society, which purely in economic terms is estimated at €23 billion per year, a level of cost that is not matched in current European hematology research funding. In recent decades, hematology research has improved our fundamental understanding of the biology of blood disorders, and has improved diagnostics and treatments, sometimes in revolutionary ways. This progress highlights the potential of focused basic research programs such as this EHA Roadmap.The EHA Roadmap identifies nine 'sections' in hematology: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation. These sections span 60 smaller groups of diseases or disorders.The EHA Roadmap identifies priorities and needs across the field of hematology, including those to develop targeted therapies based on genomic profiling and chemical biology, to eradicate minimal residual malignant disease, and to develop cellular immunotherapies, combination treatments, gene therapies, hematopoietic stem cell treatments, and treatments that are better tolerated by elderly patients. Copyright© Ferrata Storti Foundation.

Microbial biodiversity assessment of the European Space Agency's ExoMars 2016 mission.

Science.gov (United States)

Koskinen, Kaisa; Rettberg, Petra; Pukall, Rüdiger; Auerbach, Anna; Wink, Lisa; Barczyk, Simon; Perras, Alexandra; Mahnert, Alexander; Margheritis, Diana; Kminek, Gerhard; Moissl-Eichinger, Christine

2017-10-25

The ExoMars 2016 mission, consisting of the Trace Gas Orbiter and the Schiaparelli lander, was launched on March 14 2016 from Baikonur, Kazakhstan and reached its destination in October 2016. The Schiaparelli lander was subject to strict requirements for microbial cleanliness according to the obligatory planetary protection policy. To reach the required cleanliness, the ExoMars 2016 flight hardware was assembled in a newly built, biocontrolled cleanroom complex at Thales Alenia Space in Turin, Italy. In this study, we performed microbiological surveys of the cleanroom facilities and the spacecraft hardware before and during the assembly, integration and testing (AIT) activities. Besides the European Space Agency (ESA) standard bioburden assay, that served as a proxy for the microbiological contamination in general, we performed various alternative cultivation assays and utilised molecular techniques, including quantitative PCR and next generation sequencing, to assess the absolute and relative abundance and broadest diversity of microorganisms and their signatures in the cleanroom and on the spacecraft hardware. Our results show that the bioburden, detected microbial contamination and microbial diversity decreased continuously after the cleanroom was decontaminated with more effective cleaning agents and during the ongoing AIT. The studied cleanrooms and change room were occupied by very distinct microbial communities: Overall, the change room harboured a higher number and diversity of microorganisms, including Propionibacterium, which was found to be significantly increased in the change room. In particular, the so called alternative cultivation assays proved important in detecting a broader cultivable diversity than covered by the standard bioburden assay and thus completed the picture on the cleanroom microbiota. During the whole project, the bioburden stayed at acceptable level and did not raise any concern for the ExoMars 2016 mission. The cleanroom complex at

Sample collections from healthy volunteers for biological variation estimates' update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine.

Science.gov (United States)

Carobene, Anna; Strollo, Marta; Jonker, Niels; Barla, Gerhard; Bartlett, William A; Sandberg, Sverre; Sylte, Marit Sverresdotter; Røraas, Thomas; Sølvik, Una Ørvim; Fernandez-Calle, Pilar; Díaz-Garzón, Jorge; Tosato, Francesca; Plebani, Mario; Coşkun, Abdurrahman; Serteser, Mustafa; Unsal, Ibrahim; Ceriotti, Ferruccio

2016-10-01

Biological variation (BV) data have many fundamental applications in laboratory medicine. At the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) the reliability and limitations of current BV data were discussed. The EFLM Working Group on Biological Variation is working to increase the quality of BV data by developing a European project to establish a biobank of samples from healthy subjects to be used to produce high quality BV data. The project involved six European laboratories (Milan, Italy; Bergen, Norway; Madrid, Spain; Padua, Italy; Istanbul, Turkey; Assen, The Netherlands). Blood samples were collected from 97 volunteers (44 men, aged 20-60 years; 43 women, aged 20-50 years; 10 women, aged 55-69 years). Initial subject inclusion required that participants completed an enrolment questionnaire to verify their health status. The volunteers provided blood specimens once per week for 10 weeks. A short questionnaire was completed and some laboratory tests were performed at each sampling consisting of blood collected under controlled conditions to provide serum, K2EDTA-plasma and citrated-plasma samples. Samples from six out of the 97 enroled subjects were discarded as a consequence of abnormal laboratory measurements. A biobank of 18,000 aliquots was established consisting of 120 aliquots of serum, 40 of EDTA-plasma, and 40 of citrated-plasma from each subject. The samples were stored at -80 °C. A biobank of well-characterised samples collected under controlled conditions has been established delivering a European resource to enable production of contemporary BV data.

Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

Science.gov (United States)

Schulman, S; Angerås, U; Bergqvist, D; Eriksson, B; Lassen, M R; Fisher, W

2010-01-01

The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.

Toxic pyrrolizidine alkaloids in herbal medicines commonly used in Ghana.

Science.gov (United States)

Letsyo, Emmanuel; Jerz, Gerold; Winterhalter, Peter; Beuerle, Till

2017-04-18

Herbal medicines have been used for centuries for the management and treatment of various ailments due to the belief that they pose only little or no health risk and side effects, and also, in part, due to their availability, affordability and/or self-supply. However, the increasing information over the recent years on the occurrence of pyrrolizidine alkaloids (PAs) in honey, herbal food and tea products has raised concerns about the safety of herbal medicines with respect to contamination. To this day, little is known on the occurrence of toxic PAs in herbal medicines, especially in tropical West Africa. The aim of this study was therefore to determine the PA content of 70 well-known and widely patronized plant-derived medicinal preparations, which are commercialized in Ghana and some West African countries, in order to ascertain their potential health risk. PAs of the herbal medicinal products, sourced from specialized drugstores and mostly regulatory approved, were analyzed for their PA content by a HPLC-ESI-MS/MS sum parameter method. The results show that a total of 60% of the analyzed herbal products were PA positive, indicating an average PA-concentration of 25.0μg/kg. The maximum PA level (1290.0μg/kg) was attributed to a regulatory-approved herbal medicine not known, according to the list of declared ingredients, to contain PA-plant parts. Interestingly, higher PA content (average, 30.2μg/kg) was detected in regulatory-approved herbal medicines, in contrast to lower amount (average, 8.0μg/kg) detected in non-regulatory-approved products. The findings of this study clearly demonstrate that herbal medicines containing PA plants as ingredients, as well as some of those containing plant species not known to produce PAs, are likely to contain hepatotoxic PA at levels higher than the daily dose in food and herbal medicinal products proposed by the European Medicines Agency (i.e. 0.35μg PA per day for 50kg adult and 0.14μg PA per day for 20kg children

HTA programme response to the challenges of dealing with orphan medicinal products: Process evaluation in selected European countries.

Science.gov (United States)

Nicod, Elena; Annemans, Lieven; Bucsics, Anna; Lee, Anne; Upadhyaya, Sheela; Facey, Karen

2017-03-28

Challenges commonly encountered in HTA of orphan medicinal products (OMPs) were identified in Advance-HTA. Since then, new initiatives have been developed to specifically address issues related to HTA of OMPs. This study aimed to understand why these new HTA initiatives in England, Scotland and at European-level were established and whether they resolve the challenges of OMPs. The work of Advance-HTA was updated with a literature review and a conceptual framework of clinical, regulatory and economic challenges for OMPs was developed. The new HTA programmes were critiqued against the conceptual framework and outstanding challenges identified. The new programmes in England and Scotland recognise the challenges identified in demonstrating the value of ultra-OMPs (and OMPs) and that they require a different process to standard HTA approaches. Wider considerations of disease and treatment experiences from a multi-stakeholder standpoint are needed, combined with other measures to deal with uncertainty (e.g. managed entry agreements). While approaches to assessing this new view of value of OMPs, extending beyond cost/QALY frameworks, differ, their criteria are similar. These are complemented by a European initiative that fosters multi-stakeholder dialogue and consensus about value determinants throughout the life-cycle of an OMP. New HTA programmes specific to OMPs have been developed but questions remain about whether they sufficiently capture value and manage uncertainty in clinical practice. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Historical versus contemporary medicinal plant uses in Ghana

DEFF Research Database (Denmark)

Soelberg, Jens; Asase, A; Akwetey, G

2015-01-01

among contemporary medicinal plant uses in Ghana and represent some of the most important Ghanaian medicinal plant species. However, 93 (69%) of the historical uses could not be traced and appears to be discontinued or forgotten. Among the Ga, two medicinal plants species have become rare or locally......ETHNOPHARMACOLOGICAL RELEVANCE: Three extraordinary, historical documents stemming from observations made in 1697, 1803 and 1817 quote medicinal plant uses among the Fante, Ga and Ashanti people of present-day Ghana, and can be linked to original botanical specimens in European herbaria....... This provides a unique opportunity to gain insight to the historical materia medica of Ghana and compare this to contemporary medicinal plant uses. By critical literary and taxonomic review, the present study (re-)establishes the earliest known history of many important Ghanaian medicinal plants, and assesses...

The practice of travel medicine in Europe.

Science.gov (United States)

Schlagenhauf, P; Santos-O'Connor, F; Parola, P

2010-03-01

Europe, because of its geographical location, strategic position on trade routes, and colonial past, has a long history of caring for travellers' health. Within Europe, there is great diversity in the practice of travel medicine. Some countries have travel medicine societies and provisions for a periodic distribution of recommendations, but many countries have no national pre-travel guidelines and follow international recommendations such as those provided by the WHO. Providers of travel medicine include tropical medicine specialists, general practice nurses and physicians, specialist 'travel clinics', occupational physicians, and pharmacists. One of the core functions of the European Centre for Disease Prevention and Control-funded network of travel and tropical medicine professionals, EuroTravNet, is to document the status quo of travel medicine in Europe. A three-pronged approach is used, with a real-time online questionnaire, a structured interview with experts in each country, and web searching.

Draft European resolution on energy transition within the European Union. Nr 597

International Nuclear Information System (INIS)

Michels, Thierry

2018-01-01

After references to European and international directives or agreements, this document aims at drawing up new flexible rules to promote energy transition within the EU. It therefore states the French National Assembly opinion on issues related to the reduction of European greenhouse emissions, the revision of the Carbon Emissions Trading Scheme, rules concerning the sharing of the burden to reduce these emissions in sectors not covered by the ETS, the revision of rules concerning energy efficiency and the energy performance of buildings, the revision of rules concerning renewable energies, the revision of rules in the electric power sector, the governance of the Union of energy, the revision of rules concerning the Agency of the Cooperation of Energy Regulators, the consideration of social impacts of energy transition, the Brexit, and the Paris agreement

Giotto: the european space probe

International Nuclear Information System (INIS)

Berner, C.; Vandenbussche, F.C.

1986-01-01

The Giotto mission is an in situ exploration of the comet Halley. It will be the European Space Agency's first operational deep-space mission, with a spacecraft-Earth distance at comet encounter of approximately 1 AU (150 000 000 km). This paper gives a summary of the mission profile, of the spacecraft design with its associated payload and ground segment [fr

Common strategic research agenda for radiation protection in medicine.

Science.gov (United States)

2017-04-01

Reflecting the change in funding strategies for European research projects, and the goal to jointly improve medical radiation protection through sustainable research efforts, five medical societies involved in the application of ionising radiation (European Association of Nuclear Medicine, EANM; European Federation of Organizations for Medical Physics. EFOMP; European Federation of Radiographer Societies, EFRS; European Society of Radiology, ESR; European Society for Radiotherapy and Oncology, ESTRO) have identified research areas of common interest and developed this first edition of the Common Strategic Research Agenda (SRA) for medical radiation protection. The research topics considered necessary and most urgent for effective medical care and efficient in terms of radiation protection are summarised in five main themes: 1. Measurement and quantification in the field of medical applications of ionising radiation 2. Normal tissue reactions, radiation-induced morbidity and long-term health problems 3. Optimisation of radiation exposure and harmonisation of practices 4. Justification of the use of ionising radiation in medical practice 5. Infrastructures for quality assurance The SRA is a living document; thus comments and suggestions by all stakeholders in medical radiation protection are welcome and will be dealt with by the European Alliance for Medical Radiation Protection Research (EURAMED) established by the above-mentioned societies. • Overcome the fragmentation of medical radiation protection research in Europe • Identify research areas of joint interest in the field of medical radiation protection • Improve the use of ionising radiation in medicine • Collect stakeholder feedback and seek consensus • Emphasise importance of clinical translation and evaluation of research results.

The advanced therapy classification procedure. Overview of experience gained so far.

Science.gov (United States)

Voltz-Girolt, C; Celis, P; Boucaumont, M; D'Apote, L; Pinheiro, M-H; Papaluca-Amati, M

2011-07-01

The classification procedure, introduced by the European Regulation on advanced therapy medicinal products (ATMPs), has received a tremendous interest from companies, academic and public sponsors developing ATMPs. This procedure gives companies the opportunity to verify whether or not the product they are developing can be considered an ATMP and can therefore benefit from the new regulatory pathway introduced in the European Union for these types of medicinal products. This procedure is optional, free of charge and may take place at any stage of the development of an ATMP in advance of applying for a marketing authorisation. In case of doubt, briefing meetings organised by the European Medicines Agency Innovation Task Force may help preparing for an ATMP classification and are a starting point for the interactions between the Agency and the developers of ATMPs. This article reviews the advantages of the classification procedure for both the developers of ATMPs and the European regulatory network. Since the introduction of this procedure and up to 10 November 2010, the Committee for Advanced Therapies (CAT) has finalised 38 applications for classification.

The Education, Audiovisual and Culture Executive Agency: Helping You Grow Your Project

Science.gov (United States)

Education, Audiovisual and Culture Executive Agency, European Commission, 2011

2011-01-01

The Education, Audiovisual and Culture Executive Agency (EACEA) is a public body created by a Decision of the European Commission and operates under its supervision. It is located in Brussels and has been operational since January 2006. Its role is to manage European funding opportunities and networks in the fields of education and training,…

Agreement reached on integrated safeguards in European Union

International Nuclear Information System (INIS)

2010-01-01

Full text: The International Atomic Energy Agency (IAEA), in cooperation with the European Commission, has reached agreement on arrangements to implement 'integrated safeguards' in all non-nuclear-weapon States of the European Union with significant nuclear activities. 'This important milestone is the result of the constructive common efforts of all parties concerned. It is a clear signal of the importance attributed by the EU and its Member States, as well as the IAEA, to the reinforcement of the nuclear non-proliferation regime,' said Andris Piebalgs, Member of the European Commission in charge of Energy. 'Once we have sufficient confidence that a State' s nuclear activities are purely peaceful, we can apply safeguards measures in a less prescriptive, more customised manner. This reduces the inspection burden on the State and the inspection effort of the IAEA, while enabling the IAEA to maintain the conclusion that all nuclear material has remained in peaceful activities,' said Olli Heinonen, Deputy Director General and Head of IAEA Safeguards Department. Background The Nuclear Non-Proliferation Treaty (NPT) is the main international Treaty prohibiting the spread of nuclear weapons. It entrusts the IAEA to verify that nuclear material is not diverted to nuclear weapons or other nuclear explosive devices through the application of 'safeguards'. IAEA safeguards include comprehensive safeguards agreements and additional protocols that enable the IAEA to conclude that all nuclear material has remained in peaceful activities in a State. Integrated Safeguards refers to the optimum combination of all safeguards measures available to the Agency under comprehensive safeguards agreements and additional protocols to achieve maximum effectiveness and efficiency in meeting the Agency ' s safeguards obligations. In the European Union, nuclear safeguards are implemented on the basis of the Euratom Treaty and trilateral agreements between Euratom, its Member States and the IAEA

Diversity of Pharmacological Properties in Chinese and European Medicinal Plants: Cytotoxicity, Antiviral and Antitrypanosomal Screening of 82 Herbal Drugs

Directory of Open Access Journals (Sweden)

Thomas Efferth

2011-09-01

Full Text Available In an extensive screening, the antiviral, antitrypanosomal and anticancer properties of extracts from 82 plants used in traditional Chinese medicine and European phytomedicine were determined. Several promising plants that were highly effective against hepatitis B virus (HBV, bovine viral diarrhoea virus (BVDV—a flavivirus used here as a surrogate in vitro model of hepatitis C virus, trypanosomes (Trypanosoma brucei brucei and several cancer cell lines were identified. Six aqueous extracts from Celosia cristata, Ophioglossum vulgatum, Houttuynia cordata, Selaginella tamariscina, Alpinia galanga and Alpinia oxyphylla showed significant antiviral effects against BVDV without toxic effects on host embryonic bovine trachea (EBTr cells, while Evodia lepta, Hedyotis diffusa and Glycyrrhiza spp. demonstrated promising activities against the HBV without toxic effects on host human hepatoblastoma cells transfected with HBV-DNA (HepG2 2.2.15 cells. Seven organic extracts from Alpinia oxyphylla, Coptis chinensis, Kadsura longipedunculata, Arctium lappa, Panax ginseng, Panax notoginseng and Saposhnikovia divaricata inhibited T. b. brucei. Moreover, among fifteen water extracts that combined high antiproliferative activity (IC50 0.5–20 µg/mL and low acute in vitro toxicity (0–10% reduction in cell viability at IC50, Coptis chinensis presented the best beneficial characteristics. In conclusion, traditional herbal medicine from Europe and China still has a potential for new therapeutic targets and therapeutic applications.

Pirfenidone treatment in idiopathic pulmonary fibrosis

DEFF Research Database (Denmark)

Salih, Goran Nadir; Shaker, Saher Burhan; Madsen, Helle Dall

2016-01-01

BACKGROUND: Pirfenidone was approved by the European Medicines Agency and introduced in most European countries in 2011 for treatment of idiopathic pulmonary fibrosis (IPF). OBJECTIVE: To describe the national Danish experiences of pirfenidone treatment for IPF during 30 months with respect...

Dossier for marketing authorization in the European union

Directory of Open Access Journals (Sweden)

Maida Todić

2003-02-01

Full Text Available Extensive and complete documentation must be presented for marketing authorization of a medicinal product in the EU. Presented documentation should prove quality, safety and efficacy of the medicinal product. It is ensured that the applicant supplies the authorities with complete information. The legislation in Federation of Bosnia and Herzegovina has also taken more steps towards those European directions.The presentation and content of the dossier in the European Union has been redefined. The “old” EU format will be replaced with the Common Technical Document (EU CTD format agreed in 2000, within the International Conference on Harmonization framework. These two formats are intended to coexist during the transition period until July 2003. The CTD is an internationally agreed upon format for the preparation of a well structured presentation for applications to be submitted to regulatory authorities in the three ICH regions of Europe, US and Japan.

Security Economics and European Policy

Science.gov (United States)

Anderson, Ross; Böhme, Rainer; Clayton, Richard; Moor, Tyler

In September 2007, we were awarded a contract by the European Network and Information Security Agency (ENISA) to investigate failures in the market for secure electronic communications within the European Union, and come up with policy recommendations. In the process, we spoke to a large number of stakeholders, and held a consultative meeting in December 2007 in Brussels to present draft proposals, which established most had wide stakeholder support. The formal outcome of our work was a detailed report, “Security Economics and the Internal Market”, published by ENISA in March 2008. This paper presents a much abridged version: in it, we present the recommendations we made, along with a summary of our reasoning.

Nuclear medicine research: an evaluation of the ERDA program

International Nuclear Information System (INIS)

1976-08-01

Legislation which established the Energy Research and Development Administration (ERDA) January 19, 1975, stipulated that this new agency should be responsible for all activities previously assigned to the Atomic Energy Commission (AEC) and not specifically assigned to other agencies. Such activities included the nuclear medicine research program of the AEC Division of Biomedical and Environmental Research (DBER). To determine whether continuation of this program under the broader ERDA mission of energy-related research was in fact appropriate, a special task force was appointed in January 1975 by Dr. James L. Liverman, the director of DBER. This task force, comprised of established scientists knowledgeable about issues related to nuclear medicine either currently or in the past, was charged specifically to assess the historical impact of the AEC/ERDA nuclear medicine program on the development of nuclear medicine, the current status of this program, and its future role within the structure of ERDA. The specific recommendations, in brief form, are as follows: the federal government should continue to support the medical application of nuclear technology; ERDA should retain primary responsibility for support and management of federal nuclear medicine research programs; and management and emphasis of the ERDA nuclear medicine program require modification in certain areas, which are set forth

[Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products].

Science.gov (United States)

Lehmann, Jörg; Schulz, Ronny M; Sanzenbacher, Ralf

2015-11-01

For the development of medicinal products animal models are still indispensable to demonstrate efficacy and safety prior to first use in humans. Advanced therapy medicinal products (ATMP), which include cell-based medicinal products (CBMP), differ in their pharmacology and toxicology compared to conventional pharmaceuticals, and thus, require an adapted regime for non-clinical development. Developers are, therefore, challenged to develop particular individual concepts and to reconcile these with regulatory agencies. Guidelines issued by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other sources can provide direction.The published approaches for non-clinical testing of efficacy document that homologous animal models where the therapeutic effect is investigated in a disease-relevant animal model utilizing cells derived from the same species are commonly used. The challenge is that the selected model should reflect the human disease in all critical features and that the cells should be comparable to the investigated human medicinal product in terms of quality and biological activity. This is not achievable in all cases. In these cases, alternative methods may provide supplemental information. To demonstrate the scientific proof-of-concept (PoC), small animal models such as mice or rats are preferred. During the subsequent product development phase, large animal models (i.e. sheep, minipigs, dogs) must be considered, as they may better reflect the anatomical or physiological situation in humans. In addition to efficacy, those models may also be suitable to prove some safety aspects of ATMP (e.g. regarding dose finding, local tolerance, or undesired interactions and effects of the administered cells in the target tissue). In contrast, for evaluation of the two prominent endpoints for characterizing the safety of ATMP (i.e. biodistribution, tumorigenicity) heterologous small animal models, especially immunodeficient mouse strains

The revision of RP 91 on criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations

International Nuclear Information System (INIS)

Faulkner, K.; Malone, J. F.; Christofides, S.; Lillicrap, S.; Horton, P.

2013-01-01

In 1997 the European Commission published Radiation Protection 91: 'Criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations'(1). This document specified the minimum criteria for acceptability. It has been used to this effect in legislation, codes of practice and by individual professionals. In a single document, it defined a level of performance at which remedial action was required. The document specified a series of parameters which characterised equipment performance and acceptable levels of performance. In its time it proved to be a useful document which was applied in member states to various degrees. Since the publication of Report 91 in 1997(1), a series of weaknesses emerged over time. Development of new radiological systems and technologies, as well as improvements in traditional technologies, has created circumstances where the acceptability criteria were in need of review. These weaknesses were recognised by the European Commission and a tender for its revision was issued. The criteria were developed by a team drawn from a broad range of backgrounds including hospitals, industry, government bodies, regulators and standardisation organisations. Representatives were mainly from Europe, but individuals from the American Association of Physicists in Medicine and International Atomic Energy Agency were included in the drafting process. This study describes the process employed in developing the revised document and the consultation process involved. One of the major difficulties the revision team encountered was related to an understanding of the actual meaning of the EC Directive(2). The view taken by the revision team was that Article 8, paragraph 3 places responsibilities on both the holders of radiological equipment and competent authorities. The acceptability criteria have been produced consistent with the European Commission's Medical Exposures Directive(2), which requires that patient exposures are

Pharmaceuticals and Their Impact on the Environment

Directory of Open Access Journals (Sweden)

Tomić, S

2010-07-01

Full Text Available Pharmaceuticals are a class of emerging environmental contaminants that are extensively and increasingly being used in human and veterinary medicine and are released continuously into the environment. A variety of pharmaceuticals have been detected in many environmental samples worldwide. The establishment of chemical analysis methods able to determine more polar compounds allow the determination and identification of trace quantities of drugs and their metabolites. Most regulatory agencies require that environmental risk assessment is performed as an integral part of their approval procedures for the marketing for medicinal products. Marketing approval for medicinal products in the European Union is regulated by the Directive 2001/83/EC. Based on the Directive, the European Medicines Agency (EMA has published guidelines describing the procedure for the environmental risk assessment for medicinal products marketed in the EU. The requirements for the Environmental risk assessment (ERA in Croatia are regulated by the Medicinal Products Act (Official Gazette No. 71/07 and the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 113/08.

Analysis of the citation of articles published in the European Journal of Emergency Medicine since its foundation.

Science.gov (United States)

Fernández-Guerrero, Inés M; Martín-Sánchez, Francisco J; Burillo-Putze, Guillermo; Graham, Collin A; Miró, Òscar

2017-10-09

The aim of this study was to evaluate the evolution of the citation of articles from the European Journal of Emergency Medicine (EJEM) from 1994 (EJEM foundation) to 2015 and identify highly cited articles and their principal characteristics and determine a possible correlation between the citations counted in different databases. We obtained the articles published in EJEM from 1994 to 2015 in ISI-WoS (main source) and Scopus, Google Scholar, and Medline databases (accessory sources). The citations were quantified and their annual evolution and the bibliometric indices derived (impact factor and SCImago Journal Rank) were evaluated. We identified and analyzed the highly cited EJEM articles and evaluated the possible correlation between the citations counted for these articles in the databases. Overall, 1705 EJEM articles were cited 9422 times in 8122 different articles. The evolution of the global citation, impact factor, and SCImago Journal Rank from 1994 to 2015 increased significantly. The h-index of EJEM was 30, and 31 articles were considered highly cited (≥30 citations), 16.1% of them being clinical trials. By subjects, 22.5% corresponded to cardiology, 19.3% to emergency department management, and 12.9% to pediatrics; by countries, 81% were from Europe, with Belgian authors publishing four (12.9%) highly cited articles, and French, Spanish, British, and Swedish authors having three (9.7%) each. Two studies in the EJEM achieved the definition of 'citation classics' (more than 100 citations). The number of citations in all the databases, except Medline, showed statistically significant correlations. Citation of EJEM articles has progressively increased and EJEM bibliometric indicators have improved; most highly cited articles are mainly by European authors.

International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia: Guidelines for the management of hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP) of the European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and Asociación Latinoamericana del Tórax (ALAT).

Science.gov (United States)

Torres, Antoni; Niederman, Michael S; Chastre, Jean; Ewig, Santiago; Fernandez-Vandellos, Patricia; Hanberger, Hakan; Kollef, Marin; Li Bassi, Gianluigi; Luna, Carlos M; Martin-Loeches, Ignacio; Paiva, J Artur; Read, Robert C; Rigau, David; Timsit, Jean François; Welte, Tobias; Wunderink, Richard

2017-09-01

The most recent European guidelines and task force reports on hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) were published almost 10 years ago. Since then, further randomised clinical trials of HAP and VAP have been conducted and new information has become available. Studies of epidemiology, diagnosis, empiric treatment, response to treatment, new antibiotics or new forms of antibiotic administration and disease prevention have changed old paradigms. In addition, important differences between approaches in Europe and the USA have become apparent.The European Respiratory Society launched a project to develop new international guidelines for HAP and VAP. Other European societies, including the European Society of Intensive Care Medicine and the European Society of Clinical Microbiology and Infectious Diseases, were invited to participate and appointed their representatives. The Latin American Thoracic Association was also invited.A total of 15 experts and two methodologists made up the panel. Three experts from the USA were also invited (Michael S. Niederman, Marin Kollef and Richard Wunderink).Applying the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology, the panel selected seven PICO (population-intervention-comparison-outcome) questions that generated a series of recommendations for HAP/VAP diagnosis, treatment and prevention. Copyright ©ERS 2017.

A trifocal perspective on medicine as a moral enterprise: towards an authentic philosophy of medicine.

Science.gov (United States)

Ssebunnya, Gerald M

2015-02-01

The fundamental claim that the practice of medicine is essentially a moral enterprise remains highly contentious, not least among the dominant traditional moral theories. The medical profession itself is today characterized by multicultural pluralism and moral relativism that have left the Hippocratic moral tradition largely in disarray. In this paper, I attempt to clarify the ambiguity about practicing medicine as a moral enterprise and echo Pellegrino's call for a phenomenologically and teleologically derived philosophy of medicine. I proffer a realistic trifocal matrix in which the virtuous moral agency and the teleologically derived moral imperative of the physician are comprehensively integrated with an action-guiding practical analytical framework for the resolution of ethical dilemmas in medicine. I argue that this trifocal perspective points us towards an authentic philosophy of medicine that is not only verifiable through Lonerganian self-appropriation, but also authentically objective through the possible moral self-transcendence of the good physician. © The Author 2014. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

European trauma guideline compliance assessment: the ETRAUSS study.

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Hamada, Sophie Rym; Gauss, Tobias; Pann, Jakob; Dünser, Martin; Leone, Marc; Duranteau, Jacques

2015-12-08

Haemorrhagic shock is the leading cause of preventable death in trauma patients. The 2013 European trauma guidelines emphasise a comprehensive, multidisciplinary, protocol-based approach to trauma care. The aim of the present Europe-wide survey was to compare 2015 practice with the 2013 guidelines. A group of members of the Trauma and Emergency Medicine section of the European Society of Intensive Care Medicine developed a 50-item questionnaire based upon the core recommendations of the 2013 guidelines, employing a multistep approach. The questionnaire covered five fields: care structure and organisation, haemodynamic resuscitation targets, fluid management, transfusion and coagulopathy, and haemorrhage control. The sampling used a two-step approach comprising initial purposive sampling of eminent trauma care providers in each European country, followed by snowball sampling of a maximum number of trauma care providers. A total of 296 responses were collected, 243 (81 %) from European countries. Those from outside the European Union were excluded from the analysis. Approximately three-fourths (74 %) of responders were working in a designated trauma centre. Blunt trauma predominated, accounting for more than 90 % of trauma cases. Considerable heterogeneity was observed in all five core aspects of trauma care, along with frequent deviations from the 2013 guidelines. Only 92 (38 %) of responders claimed to comply with the recommended systolic blood pressure target, and only 81 (33 %) responded that they complied with the target pressure in patients with traumatic brain injury. Crystalloid use was predominant (n = 209; 86 %), and vasopressor use was frequent (n = 171, 76 %) but remained controversial. Only 160 respondents (66 %) declared that they used tranexamic acid always or often. This is the first European trauma survey, to our knowledge. Heterogeneity is significant across centres with regard to the clinical protocols for trauma patients and as to locally

European Summit on the Prevention and Self-Management of Chronic Respiratory Diseases: report of the European Union Parliament Summit (29 March 2017).

Science.gov (United States)

Hellings, Peter W; Borrelli, David; Pietikainen, Sirpa; Agache, Ioana; Akdis, Cezmi; Bachert, Claus; Bewick, Michael; Botjes, Erna; Constantinidis, Jannis; Fokkens, Wytske; Haahtela, Tari; Hopkins, Claire; Illario, Maddalena; Joos, Guy; Lund, Valerie; Muraro, Antonella; Pugin, Benoit; Seys, Sven; Somekh, David; Stjärne, Pär; Valiulis, Arunas; Valovirta, Erkka; Bousquet, Jean

2017-01-01

On March 29, 2017, a European Summit on the Prevention and Self-Management of Chronic Respiratory Diseases (CRD) was organized by the European Forum for Research and Education in Allergy and Airway Diseases. The event took place in the European Parliament of Brussels and was hosted by MEP David Borrelli and MEP Sirpa Pietikainen. The aim of the Summit was to correspond to the needs of the European Commission and of patients suffering from CRD to join forces in Europe for the prevention and self-management. Delegates of the European Rhinologic Society, European Respiratory Society, European Academy of Allergy and Clinical Immunology, European Academy of Paediatrics, and European Patients Organization EFA all lectured on their vision and action plan to join forces in achieving adequate prevention and self-management of CRD in the context of Precision Medicine. Recent data highlight the preventive capacity of education on optimal care pathways for CRD. Self-management and patient empowerment can be achieved by novel educational on-line materials and by novel mobile health tools enabling patients and doctors to monitor and optimally treat CRDs based on the level of control. This report summarizes the contributions of the representatives of different European academic stakeholders in the field of CRD.

Detection of pigments of halophilic endoliths from gypsum: Raman portable instrument and European Space Agency's prototype analysis

Science.gov (United States)

Culka, Adam; Osterrothová, Kateřina; Hutchinson, Ian; Ingley, Richard; McHugh, Melissa; Oren, Aharon; Edwards, Howell G. M.; Jehlička, Jan

2014-01-01

A prototype instrument, under development at the University of Leicester, for the future European Space Agency (ESA) ExoMars mission, was used for the analysis of microbial pigments within a stratified gypsum crust from a hypersaline saltern evaporation pond at Eilat (Israel). Additionally, the same samples were analysed using a miniaturized Raman spectrometer, featuring the same 532 nm excitation. The differences in the position of the specific bands, attributed to carotenoid pigments from different coloured layers, were minor when analysed by the ESA prototype instrument; therefore, making it difficult to distinguish among the different pigments. The portable Delta Nu Advantage instrument allowed for the discrimination of microbial carotenoids from the orange/green and purple layers. The purpose of this study was to complement previous laboratory results with new data and experience with portable or handheld Raman systems, even with a dedicated prototype Raman system for the exploration of Mars. The latter is equipped with an excitation wavelength falling within the carotenoid polyene resonance region. The ESA prototype Raman instrument detected the carotenoid pigments (biomarkers) with ease, although further detailed distinctions among them were not achieved. PMID:25368354

Detection of pigments of halophilic endoliths from gypsum: Raman portable instrument and European Space Agency's prototype analysis.

Science.gov (United States)

Culka, Adam; Osterrothová, Kateřina; Hutchinson, Ian; Ingley, Richard; McHugh, Melissa; Oren, Aharon; Edwards, Howell G M; Jehlička, Jan

2014-12-13

A prototype instrument, under development at the University of Leicester, for the future European Space Agency (ESA) ExoMars mission, was used for the analysis of microbial pigments within a stratified gypsum crust from a hypersaline saltern evaporation pond at Eilat (Israel). Additionally, the same samples were analysed using a miniaturized Raman spectrometer, featuring the same 532 nm excitation. The differences in the position of the specific bands, attributed to carotenoid pigments from different coloured layers, were minor when analysed by the ESA prototype instrument; therefore, making it difficult to distinguish among the different pigments. The portable Delta Nu Advantage instrument allowed for the discrimination of microbial carotenoids from the orange/green and purple layers. The purpose of this study was to complement previous laboratory results with new data and experience with portable or handheld Raman systems, even with a dedicated prototype Raman system for the exploration of Mars. The latter is equipped with an excitation wavelength falling within the carotenoid polyene resonance region. The ESA prototype Raman instrument detected the carotenoid pigments (biomarkers) with ease, although further detailed distinctions among them were not achieved. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

Precision medicine in patients with allergic diseases

DEFF Research Database (Denmark)

Muraro, Antonella; Lemanske, Robert F; Hellings, Peter W

2016-01-01

In this consensus document we summarize the current knowledge on major asthma, rhinitis, and atopic dermatitis endotypes under the auspices of the PRACTALL collaboration platform. PRACTALL is an initiative of the European Academy of Allergy and Clinical Immunology and the American Academy...... of Allergy, Asthma & Immunology aiming to harmonize the European and American approaches to best allergy practice and science. Precision medicine is of broad relevance for the management of asthma, rhinitis, and atopic dermatitis in the context of a better selection of treatment responders, risk prediction...

Curriculum for education and training of Medical Physicists in Nuclear Medicine

DEFF Research Database (Denmark)

Del Guerra, Alberto; Bardies, Manuel; Belcari, Nicola

2013-01-01

and Competence approach along the lines recommended by the European Qualifications Framework. The minimum level expected in each topic in the theoretical knowledge and practical experience sections is intended to bring trainees up to the requirements expected of a Medical Physicist entering the field of Nuclear...... Medicine. CONCLUSIONS: This new joint EANM/EFOMP European guideline curriculum is a further step to harmonise specialist training of Medical Physicists in Nuclear Medicine within Europe. It provides a common framework for national Medical Physics societies to develop or benchmark their own curricula....... The responsibility for the implementation and accreditation of these standards and guidelines resides within national training and regulatory bodies....

Oral antineoplastic agent interactions with medicinal plants and food: an issue to take into account.

Science.gov (United States)

Collado-Borrell, Roberto; Escudero-Vilaplana, Vicente; Romero-Jiménez, Rosa; Iglesias-Peinado, Irene; Herranz-Alonso, Ana; Sanjurjo-Sáez, María

2016-11-01

To review interactions between oral antineoplastic agents (OAAs) for the treatment of solid and hematological tumors and common food and medicinal plants. All potential interactions between OAAs, medicinal plants and food were reviewed. OAAs were considered to be drugs for oral administration that have direct antitumor activity and were approved by the European Medicines Agency in April 2015. We performed the literature search in Pubmed(®) considering only medicinal plants and food. In addition, available data were analyzed from each OAA in secondary data sources taken from Thomson Micromedex(®) and Lexi-comp(®), as well as in the summary of product characteristics. Fifty-eight OAAs were analyzed. We found interactions in 60.3 % of OAAs. Those with most interactions described were: imatinib and procarbazine (4 interactions) and erlotinib, vemurafenib, pomalidomide, medroxyprogesterone and methotrexate (3 interactions). We found 39 interactions (74.4 % important). St. John's wort was the medicinal plant with most interactions (92.6 % were considered important). The rest were: important (ginseng-imatinib, methotrexate-cola and tobacco-erlotinib and tobacco-pomalidomide) and moderate (caffeine-vemurafenib/medroxyprogesterone, medroxyprogesterone-ruxolitinib/St. John's wort, garlic-anagrelide and ginseng-procarbazine). Twenty-six interactions (61.5 % important). Grapefruit had most interactions (82.4 % were considered important). The rest were: important (alcohol-procarbazine) and moderate (dairy-estramustine, methotrexate-ethanol, procarbazine-tyramine, vitamin A-tretinoin/bexarotene and grapefruit-bexarotene/etoposide/sunitinib). A review of interactions of medicinal plants and food should be taken into account in the management of OAAs, since more than half have interactions with MPs and food, of which 70.3 % are considered important. The most relevant are HSJ, grapefruit, ginseng and tobacco. This review is intended to serve as a support to all healthcare

[Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

Science.gov (United States)

Kuhlmann-Gottke, Johanna; Duchow, Karin

2015-11-01

At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

Perspectives in molecular imaging through translational research, human medicine, and veterinary medicine.

Science.gov (United States)

Berry, Clifford R; Garg, Predeep

2014-01-01

The concept of molecular imaging has taken off over the past 15 years to the point of the renaming of the Society of Nuclear Medicine (Society of Nuclear Medicine and Molecular Imaging) and Journals (European Journal of Nuclear Medicine and Molecular Imaging) and offering of medical fellowships specific to this area of study. Molecular imaging has always been at the core of functional imaging related to nuclear medicine. Even before the phrase molecular imaging came into vogue, radionuclides and radiopharmaceuticals were developed that targeted select physiological processes, proteins, receptor analogs, antibody-antigen interactions, metabolites and specific metabolic pathways. In addition, with the advent of genomic imaging, targeted genomic therapy, and theranostics, a number of novel radiopharmaceuticals for the detection and therapy of specific tumor types based on unique biological and cellular properties of the tumor itself have been realized. However, molecular imaging and therapeutics as well as the concept of theranostics are yet to be fully realized. The purpose of this review article is to present an overview of the translational approaches to targeted molecular imaging with application to some naturally occurring animal models of human disease. © 2013 Published by Elsevier Inc.

Education in infection control : A need for European certification

NARCIS (Netherlands)

Zingg, W.; Mutters, N. T.; Harbarth, S.; Friedrich, A. W.

2015-01-01

Healthcare-associated infections are common adverse events in acute-care medicine, causing significant morbidity and mortality. There has been a significant increase in the commitment to infection prevention and control (IPC) among European countries in recent years. However, there is still

EUROPEAN UNION AND THE PROCESS OF GLOBALIZATION

Directory of Open Access Journals (Sweden)

Mihail CARADAICĂ

2014-05-01

Full Text Available What is the relation between globalization and the process of European integration? Does the European integration have its own way, or is it deeply dependent on globalization? Those are the main questions I will try to answer in this paper by using an alternative critical approach: neo-gramscianism. Neo-gramscianism is a historical materialist view on the European integration process and international political economy which offers a better understanding of the social changes in terms of social forces agency and super structural influence (the neoliberal ideology of globalization and European integration. My aim is to analyze the globalization process through a neo-gramscian theoretical framework and to observe how its main components affect European Integration. I will do this by assuming the definition of globalization provided by Andreas Bieler, who understands this process through three main pillars: transnationalization of finance, transnationalization of production and ideological shift from Keynesianism to neoliberalism. Finally I will try to formulate some conclusions regarding the emergence of European Round Table of Industrialists – the first lobby group of big capital at the European Union level – and Economic and Monetary Union – the internal market program that symbolizes the shift to neo-liberalism.

The Market for Hospital Medicine in Denmark

DEFF Research Database (Denmark)

Hostenkamp, Gisela

2012-01-01

Pharmaceutical expenditure growth has outpaced GDP and healthcare expenditure growth rates in Denmark as in most OECD countries for the last decade. A major part of this increase was due to high growth rates in specialist areas that are typically located in hospital settings. Yet the market...... for hospital medicines and their procurement are still poorly understood. The present paper characterises the market for hospital medicines in Denmark in terms of its organisation and developments between 2005 and 2009. In Denmark hospital medicines are publicly financed and procurement is centrally organised....... 98% of all medicines administered at Danish public hospitals are purchased through a public procurement agency by means of public tenders. Using data on actual contract prices we decompose pharmaceutical expenditure growth into the contributions from newly introduced medicines, price and volume...

European influence on Russian neurology in the eighteenth and nineteenth centuries.

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Shterenshis, Michael; Vaiman, Michael

2007-01-01

In this study we consider the development of clinical neurology in the eighteenth and the nineteenth centuries focusing on European influence on Russian medicine. Russian physicians readily accepted newly described clinical signs, theories, and classification of nervous diseases designed in Europe. This influence initiated neurology's separation from general medicine and its transformation into a new clinical discipline. In Russia this happened already in the 1860s, decades before the similar trend in Europe. The Russian example is nearly unknown in the general history of neurology. It illustrates the relationships between physiology and practical neurology at the moment of establishment of the new discipline. It also shows that the Russian physicians of the time readily accepted European medical knowledge putting it immediately into medical practice and education.

Modern European monographs for quality control of Chinese herbs.

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Bauer, Rudolf; Franz, Gerhard

2010-12-01

The actual concern about the safety and efficacy of herbal drugs originating from traditional Chinese medicine (TCM) is based on observations that these medicinal plants may have a high risk potential due to insufficient definitions, problems with identity, purity and falsifications. No uniform legal status for these groups of herbal drugs currently exists in the European Union. For quality control, monographs for TCM herbs can mainly be found in the Pharmacopoeia of the Peoples Republic of China. Based on these facts the Commission of the European Pharmacopoeia decided in 2005 to establish TCM-herbal drug monographs for the most important medicinal plants imported from Far East. These new monographs had to be established and evaluated on the basis of existing monographs in the Chinese Pharmacopoeia (ChP), English edition 2005. Due to important differences in the overall features of EP and ChP, a simple adapt/adopt procedure was not feasible. Therefore, specialist groups were mandated with a corresponding working programme. Some results and actual problems related to this working programme will be presented and discussed. © Georg Thieme Verlag KG Stuttgart · New York.

Current Status of Legislation on Dietary Products for Sportspeople in a European Framework.

Science.gov (United States)

Martínez-Sanz, José Miguel; Sospedra, Isabel; Baladía, Eduard; Arranz, Laura; Ortiz-Moncada, Rocío; Gil-Izquierdo, Angel

2017-11-08

The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition) and European (European Commission and European Food Safety Authority) bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1) Advertising of any type of food and/or product; (2) Composition, labeling, and advertising of foods; (3) Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids.

Healthy lifestyle interventions to combat noncommunicable disease-a novel nonhierarchical connectivity model for key stakeholders: a policy statement from the American Heart Association, European Society of Cardiology, European Association for Cardiovascular Prevention and Rehabilitation, and American College of Preventive Medicine.

Science.gov (United States)

Arena, Ross; Guazzi, Marco; Lianov, Liana; Whitsel, Laurie; Berra, Kathy; Lavie, Carl J; Kaminsky, Leonard; Williams, Mark; Hivert, Marie-France; Cherie Franklin, Nina; Myers, Jonathan; Dengel, Donald; Lloyd-Jones, Donald M; Pinto, Fausto J; Cosentino, Francesco; Halle, Martin; Gielen, Stephan; Dendale, Paul; Niebauer, Josef; Pelliccia, Antonio; Giannuzzi, Pantaleo; Corra, Ugo; Piepoli, Massimo F; Guthrie, George; Shurney, Dexter; Arena, Ross; Berra, Kathy; Dengel, Donald; Franklin, Nina Cherie; Hivert, Marie-France; Kaminsky, Leonard; Lavie, Carl J; Lloyd-Jones, Donald M; Myers, Jonathan; Whitsel, Laurie; Williams, Mark; Corra, Ugo; Cosentino, Francesco; Dendale, Paul; Giannuzzi, Pantaleo; Gielen, Stephan; Guazzi, Marco; Halle, Martin; Niebauer, Josef; Pelliccia, Antonio; Piepoli, Massimo F; Pinto, Fausto J; Guthrie, George; Lianov, Liana; Shurney, Dexter

2015-08-14

Noncommunicable diseases (NCDs) have become the primary health concern for most countries around the world. Currently, more than 36 million people worldwide die from NCDs each year, accounting for 63% of annual global deaths; most are preventable. The global financial burden of NCDs is staggering, with an estimated 2010 global cost of $6.3 trillion (US dollars) that is projected to increase to $13 trillion by 2030. A number of NCDs share one or more common predisposing risk factors, all related to lifestyle to some degree: (1) cigarette smoking, (2) hypertension, (3) hyperglycemia, (4) dyslipidemia, (5) obesity, (6) physical inactivity, and (7) poor nutrition. In large part, prevention, control, or even reversal of the aforementioned modifiable risk factors are realized through leading a healthy lifestyle (HL). The challenge is how to initiate the global change, not toward increasing documentation of the scope of the problem but toward true action-creating, implementing, and sustaining HL initiatives that will result in positive, measurable changes in the previously defined poor health metrics. To achieve this task, a paradigm shift in how we approach NCD prevention and treatment is required. The goal of this American Heart Association/European Society of Cardiology/European Association for Cardiovascular Prevention and Rehabilitation/American College of Preventive Medicine policy statement is to define key stakeholders and highlight their connectivity with respect to HL initiatives. This policy encourages integrated action by all stakeholders to create the needed paradigm shift and achieve broad adoption of HL behaviors on a global scale. © 2015 Mayo Foundation for Medical Education and Research, and the European Society of Cardiology. This article is being published concurrently in Mayo Clinic Proceedings [1]. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when

Power learning or path dependency? Investigating the roots of the European Food Safety Authority.

Science.gov (United States)

Roederer-Rynning, Christilla; Daugbjerg, Carsten

2010-01-01

A key motive for establishing the European Food Safety Authority (EFSA) was restoring public confidence in the wake of multiplying food scares and the BSE crisis. Scholars, however, have paid little attention to the actual political and institutional logics that shaped this new organization. This article explores the dynamics underpinning the making of EFSA. We examine the way in which learning and power shaped its organizational architecture. It is demonstrated that the lessons drawn from the past and other models converged on the need to delegate authority to an external agency, but diverged on its mandate, concretely whether or not EFSA should assume risk management responsibilities. In this situation of competitive learning, power and procedural politics conditioned the mandate granted to EFSA. The European Commission, the European Parliament and the European Council shared a common interest in preventing the delegation of regulatory powers to an independent EU agency in food safety policy.

[Falsified medicines in parallel trade].

Science.gov (United States)

Muckenfuß, Heide

2017-11-01

The number of falsified medicines on the German market has distinctly increased over the past few years. In particular, stolen pharmaceutical products, a form of falsified medicines, have increasingly been introduced into the legal supply chain via parallel trading. The reasons why parallel trading serves as a gateway for falsified medicines are most likely the complex supply chains and routes of transport. It is hardly possible for national authorities to trace the history of a medicinal product that was bought and sold by several intermediaries in different EU member states. In addition, the heterogeneous outward appearance of imported and relabelled pharmaceutical products facilitates the introduction of illegal products onto the market. Official batch release at the Paul-Ehrlich-Institut offers the possibility of checking some aspects that might provide an indication of a falsified medicine. In some circumstances, this may allow the identification of falsified medicines before they come onto the German market. However, this control is only possible for biomedicinal products that have not received a waiver regarding official batch release. For improved control of parallel trade, better networking among the EU member states would be beneficial. European-wide regulations, e. g., for disclosure of the complete supply chain, would help to minimise the risks of parallel trading and hinder the marketing of falsified medicines.

Is Temporary Agency Employment a Stepping Stone for Immigrants?

DEFF Research Database (Denmark)

Jahn, Elke; Rosholm, Michael

2013-01-01

We investigate whether agency employment is a bridge into regular employment for immigrants using the timing-of-events approach. We provide evidence of large positive in-treatment effects for all immigrants. Post-treatment effects are fairly high for male non-western and Eastern European immigrants....

Oral medicines for children in the European paediatric investigation plans

NARCIS (Netherlands)

van Riet-Nales, Diana A; Römkens, Erwin G A W; Saint-Raymond, Agnes; Kozarewicz, Piotr; Schobben, Alfred F A M; Egberts, Toine C G; Rademaker, Carin M A

2014-01-01

INTRODUCTION: Pharmaceutical industry is no longer allowed to develop new medicines for use in adults only, as the 2007 Paediatric Regulation requires children to be considered also. The plans for such paediatric development called Paediatric Investigation Plans (PIPs) are subject to agreement by

75 FR 58411 - Center for Veterinary Medicine eSubmitter Workshop; Public Workshop; Request for Comments

Science.gov (United States)

2010-09-24

...] Center for Veterinary Medicine eSubmitter Workshop; Public Workshop; Request for Comments AGENCY: Food... Drug Administration (FDA) is announcing a public workshop entitled: ``Center for Veterinary Medicine... be emailed to all registrants. Contact Person: Charles Andres, Center for Veterinary Medicine (HFV...

The medicinal plants of Frangensko Plateau (Northeastern Bulgaria)

Science.gov (United States)

Zahariev, Dimcho; Kacheva, Cvetelina

2015-12-01

The Frangensko Plateau is located in the northeastern part of Bulgaria and covers an area of 360 km2. On the territory of the plateau there are two protected areas, as well as two areas of the European ecological network NATURA 2000. The study of the medicinal plants on the territory of the Frangensko Plateau is made for the first time. As a result of our research we found 362 species of vascular plants from 242 genera and 80 families. The most of the families and the genera are represented by a small number of inferior taxa. The analysis of their life form indicates that the hemicryptophytes dominate with 39.50%, followed by the phanerophytes (22.10%). The biological types are represented mainly by perennial herbaceous plants (52.21%), annual herbaceous plants (14.09%) and trees (10.50%). There are 8 types of floristic elements divided in 32 groups. The largest percentage of species is of European type (51.93%). Among the medicinal plants, there are two Balkan endemic species, one Bulgarian endemic species and 30 relic species. Thirty four species with protection statute are described. The anthropophytes among the medicinal plants are 242 species (66.85%).

[Review on community herbal monographs for traditional herbal medicinal products].

Science.gov (United States)

Zou, Wenjun; Qu, Liping; Ye, Zuguang; Ji, Jianxin; Li, Bogang

2011-12-01

This article discusses the characteristics of cmmunity herbal monographs for traditional herbal medicinal products and its establishment procedure. It also reviews the new development of cmmunity traditional herbal monographs. The purpose is to clarify the relationship between cmmunity herbal monographs and simplified registration for traditional herbal medicinal product in European Union and provide reference to the registration of taditional Chinese mdicinal products in Europe.

[European integration and health policies: repercussions of the internal European Market on access to health services].

Science.gov (United States)

Guimarães, Luisa; Giovanella, Lígia

2006-09-01

This article explores the health policy repercussions of countries' regional integration into the European Union. The aim is to review the regulation of access in other countries, with the conclusion of the single European market and the free circulation of persons, services, goods, and capital. The article begins by reviewing the various forms of integration and describes the expansion and institutionalization of Community agencies. The repercussions of European integration on health policies and regulation of access are analyzed. Market impacts on health result from Treaty directives and internal policy adjustments to free circulation. Health services access is gradually regulated and granted by rulings. Projects along borders illustrate the dynamics where differences are used to achieve comprehensive care. In the oldest integration experience, the market regulation has generated intentional and non-intentional impacts on the health policies of member states, regardless of the organizational model. Knowledge and analysis of this experience signals challenges for the Southern Cone Common Market (Mercosur) and adds to future debates and decisions.

Harmonising relative effectiveness assessments of medicines in Europe

NARCIS (Netherlands)

Kleijnen, S.

2016-01-01

The national reimbursement decisions of new medicines in European countries are based on multiple criteria, such as the relative effectiveness, value for money, costs, social and ethical considerations. The relative effectiveness is the extent to which an intervention does more good than harm

An Internationally Intelligible Principle: Comparing the Nondelegation Doctrine in the United States and European Union

Directory of Open Access Journals (Sweden)

Grodin Edward

2015-11-01

Full Text Available This article analyzes the degree of convergence between the United States and the European Union regarding the structural role of administrative agencies. As will be argued, the United States and European Union have arrived at the same broad conclusion about a “nondelegation doctrine”: delegations to administrative agencies should be permitted so long as some limiting principle governs the exercise of that power and allows for sufficient judicial review. However, the Supreme Court has taken a more permissive approach than the Court of Justice in defining the limiting principle. The United States has loosened the reins for the sake of modern administration while the European Union has maintained a firmer grip to keep better control over the Europeanization project. Stated another way, the nondelegation doctrine is simply a reflection of the systems’ relative levels of integration. Thus, the nondelegation doctrine will be stretched in Europe as functional regulatory demands arise from wider and deeper integration. At the same time, the focus will be redirected from substantive limits to procedural controls; accordingly, this Note advocates for a European Administrative Procedure Act.

[Catalogue of learning goals for pregraduate education in geriatric medicine. A recommendation of the German Geriatric Society (DGG), the German Society of Gerontology and Geriatrics (DGGG), the Austrian Society of Geriatrics and Gerontology (ÖGGG) and the Swiss Society of Geriatric Medicine (SFGG) on the basis of recommendations of the European Union of Medical Specialists Geriatric Medicine Section (UEMS-GMS) 2013].

Science.gov (United States)

Singler, K; Stuck, A E; Masud, T; Goeldlin, A; Roller, R E

2014-11-01

Sound knowledge in the care and management of geriatric patients is essential for doctors in almost all medical subspecialties. Therefore, it is important that pregraduate medical education adequately covers the field of geriatric medicine. However, in most medical faculties in Europe today, learning objectives in geriatric medicine are often substandard or not even explicitly addressed. As a first step to encourage undergraduate teaching in geriatric medicine, the European Union of Medical Specialists -Geriatric Medicine Section (UEMS-GMS) recently developed a catalogue of learning goals using a modified Delphi technique in order to encourage education in this field. This catalogue of learning objectives for geriatric medicine focuses on the minimum requirements with specific learning goals in knowledge, skills and attitudes that medical students should have acquired by the end of their studies.In order to ease the implementation of this new, competence-based curriculum among the medical faculties in universities teaching in the German language, the authors translated the published English language curriculum into German and adapted it according to medical language and terms used at German-speaking medical faculties and universities of Austria, Germany and Switzerland. This article contains the final German translation of the curriculum. The Geriatric Medicine Societies of Germany, Austria, and Switzerland formally endorse the present curriculum and recommend that medical faculties adapt their curricula for undergraduate teaching based on this catalogue.

Mobile Marketing Applications of Travel Agencies

Directory of Open Access Journals (Sweden)

Murat Selim Selvi

2014-11-01

Full Text Available In recent years, the use of mobile devices in the marketing world is increasing parallel with technological advances. The main problem of this research is to determine agencies’ use of what type of mobile tools for what type of purposes in the marketing process. The aim of this research is to identify Mobile Marketing (MM applications used by group A travel agencies, and to describe the attitudes towards MM applications of agencies. According to related law, it is only group A agencies give all agency services. Therefore, it is thought that MM is more widely used by those agencies. Thus, this research was made only on the group A agencies. The population of study was consisted of 675 groups A agencies’ representatives deployed in the European and Asian sides of Istanbul. A questionnaire was used as data collection tool. Questionnaire form consisted of two parts. In the first part, questions concerning MM and in the second part, questions regarding demographic issues to managers and travel agents took place. The results were given as descriptive statistics (frequencies, percentages, mean and standard deviation on the tables. T-test and One Way ANOVA analysis were performed for the differences of mean among groups. In the study it was concluded that agencies use mobile phones mostly and mobile computers for increasing sales firstly and direct marketing. Thus, the main hypothesis established was confirmed partly.

Mobile Marketing Applications of Travel Agencies

Directory of Open Access Journals (Sweden)

Murat Selim Selvi

2016-01-01

Full Text Available In recent years, the use of mobile devices in the marketing world is increasing parallel with technological advances. The main problem of this research is to determine agencies’ use of what type of mobile tools for what type of purposes in the marketing process. The aim of this research is to identify Mobile Marketing (MM applications used by group A travel agencies, and to describe the attitudes towards MM applications of agencies. According to related law, it is only group A agencies give all agency services. Therefore, it is thought that MM is more widely used by those agencies. Thus, this research was made only on the group A agencies. The population of study was consisted of 675 groups A agencies’ representatives deployed in the European and Asian sides of Istanbul. A questionnaire was used as data collection tool. Questionnaire form consisted of two parts. In the first part, questions concerning MM and in the second part, questions regarding demographic issues to managers and travel agents took place. The results were given as descriptive statistics (frequencies, percentages, mean and standard deviation on the tables. T-test and One Way ANOVA analysis were performed for the differences of mean among groups. In the study it was concluded that agencies use mobile phones mostly and mobile computers for increasing sales firstly and direct marketing. Thus, the main hypothesis established was confirmed partly.

Continuous innovation in the drug life cycle

NARCIS (Netherlands)

Langedijk, J.

2016-01-01

Patients may benefit from new uses for old drugs. Competent authorities such as the European Medicines Agency evaluate the quality, efficacy and safety of a medicinal product for the use in a well-defined therapeutic indication. Innovations may continue upon the approval, for example through the

Collective effective dose in Europe from x-ray and nuclear medicine procedures

International Nuclear Information System (INIS)

Bly, R.; Jaervinen, H.; Jahnen, A.; Olerud, H.; Vassileva, J.; Vogiatzi, S.

2015-01-01

Population doses from radiodiagnostic (X-ray and nuclear medicine) procedures in Europe were estimated based on data collected from 36 European countries. For X-ray procedures in EU and EFTA countries (except Liechtenstein) the collective effective dose is 547 500 man Sv, resulting in a mean effective dose of 1.06 mSv per caput. For all European countries included in the survey the collective effective dose is 605 000 man Sv, resulting in a mean effective dose of 1.05 mSv per caput. For nuclear medicine procedures in EU countries and EFTA (except Liechtenstein) countries the collective effective dose is 30 700 man Sv, resulting in a mean effective dose of 0.06 mSv per caput. For all European countries included in the survey the collective effective dose is 31 100 man Sv, resulting in a mean effective dose of 0.05 mSv per caput. (authors)

Fostering EMA's transparency policy

DEFF Research Database (Denmark)

Banzi, Rita; Bertele', Vittorio; Demotes-Mainard, Jacques

2014-01-01

The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also prom...

76 FR 15279 - Importation of Garlic From the European Union and Other Countries Into the Continental United States

Science.gov (United States)

2011-03-21

...] Importation of Garlic From the European Union and Other Countries Into the Continental United States AGENCY... measures under which garlic may be imported into the continental United States from the European Union and..., Ukraine, and Uzbekistan. In this document, we refer to them as the European Union (EU) and other countries...

The european approach to quality assurance in diagnostic radiology

International Nuclear Information System (INIS)

Benini, A.

1997-01-01

The european and increasingly the international organizations are emphasizing the importance of appropriate quality assurance programmes in diagnostic radiology. The European Directive (particularly the directive 84/466/EURATOM). the various publications of the International Commission for radiation protection (ICRP), related to protection of the patients and workers and the Basic Safety Standards of the International Atomic Energy Agency (IAEA) might be considered the landmarks of the new approach to the problems of dose reduction and quality in diagnostic radiology. In particular ICRP maintains a watching brief on all aspects related to radiation protection and makes recommendations concerning basic principles. Since ICRP 26 (1977), several ICRP publications have dealt with all the principal fields of diagnostic radiology. The IAEA has recently published the new Basic Safety Standards including guidance levels for the most common diagnostic investigations.Within the European countries the European Union and the European legislation have strong influence of the implementation of radiation protection and Q A at a national level. This has led to a substantial effort in the european countries to establish national standards and basic quality requirements. (author)

78 FR 25417 - Notice of Request for Applications for the Veterinary Medicine Loan Repayment Program

Science.gov (United States)

2013-05-01

... Applications for the Veterinary Medicine Loan Repayment Program AGENCY: National Institute of Food and... announcing the release of the Veterinary Medicine Loan Repayment Program (VMLRP) Request for Applications (RFA) at www.nifa.usda.gov/vmlrp . DATES: The fiscal year (FY) 2013 Veterinary Medicine Loan Repayment...

77 FR 23461 - Notice of Request for Applications for the Veterinary Medicine Loan Repayment Program

Science.gov (United States)

2012-04-19

... Applications for the Veterinary Medicine Loan Repayment Program AGENCY: National Institute of Food and... announcing the release of the Veterinary Medicine Loan Repayment Program (VMLRP) Request for Applications (RFA) at www.nifa.usda.gov/vmlrp . DATES: The FY 2012 Veterinary Medicine Loan Repayment Program (VMLRP...

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Romania

International Nuclear Information System (INIS)

2010-01-01

The Agency received from Romania on 22 August 2007 and from the European Atomic Energy Community on 1 May 2010, the notifications required by Article 23(a) of the Agreement. Accordingly, the Agreement entered into force for Romania on 1 May 2010 [fr

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Romania

International Nuclear Information System (INIS)

2010-01-01

The Agency received from Romania on 22 August 2007 and from the European Atomic Energy Community on 1 May 2010, the notifications required by Article 23(a) of the Agreement. Accordingly, the Agreement entered into force for Romania on 1 May 2010 [es

The Text of the Agreement between Belgium, Denmark, the Federal Republic of Germany, Ireland, Italy, Luxembourg, The Netherlands, the European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Romania

International Nuclear Information System (INIS)

2010-01-01

The Agency received from Romania on 22 August 2007 and from the European Atomic Energy Community on 1 May 2010, the notifications required by Article 23(a) of the Agreement. Accordingly, the Agreement entered into force for Romania on 1 May 2010

The international distribution of authorship in the Nuclear Medicine literature: a bibliometric analysis

International Nuclear Information System (INIS)

Hannigan, G.G.; Bartold, S.P.

2002-01-01

Aim: This study profiles the increasingly diverse international contributions to the specialty of Nuclear Medicine as measured by publication in the European Journal of Nuclear Medicine (Springer) and the Journal of Nuclear Medicine (Society of Nuclear Medicine). These are the leading journals in the field, with 2001 impact factor scores of 3.617 and 3.772 respectively.1 Materials and Methods: We searched the MEDLINE database from 1988-2001, using the Limits (Journal) feature. 1988 is the first year that author affiliation information is reliably included on the MEDLINE record. The retrieved set of articles from the European Journal of Nuclear Medicine and the Journal of Nuclear Medicine was limited to articles with abstracts, the goal being to count only substantive articles and to eliminate editorials, letters, and other brief communications. Since author affiliation information is neither standardized nor can it be sorted in MEDLINE, we manually counted and categorized publications by country of the first author as listed in the article. Microsoft Excel was used to tabulate and analyze the data. Results: 2,634 articles were analyzed for six years (1988, 1991, 1992, 1993, 1996, 2001). Authors from 40 countries published in these two journals. In 1988, authors from seven countries (US, Japan, UK, France, Germany, the Netherlands, Canada) contributed ten or more articles, accounting for 80% of the articles . In 2001, authors from eleven countries contributed ten or more articles, accounting for 86% of the total (US, Germany, Japan, Netherlands, Italy, Belgium, Australia, France, UK, Spain, Finland); Conclusions: A previous study showed that, from 1980-97, seven countries accounted for 86% of the research articles in the Journal of Nuclear Medicine: US 60.2%, Japan 8.6%, and Canada, France, Germany, UK, Netherlands each 3.4%.2. In this study, for the six years included, authors from ten countries accounted for 86% of the research articles in the European Journal of

Herbal medicine research and global health: an ethical analysis

OpenAIRE

Tilburt, Jon C; Kaptchuk, Ted J

2008-01-01

Governments, international agencies and corporations are increasingly investing in traditional herbal medicine research. Yet little literature addresses ethical challenges in this research. In this paper, we apply concepts in a comprehensive ethical framework for clinical research to international traditional herbal medicine research. We examine in detail three key, underappreciated dimensions of the ethical framework in which particularly difficult questions arise for international herbal me...

Nuclear medicine - the state of the art of nuclear medicine in Europe

International Nuclear Information System (INIS)

Schmidt, H.A.E.; Schoot, J.B. van der

1991-01-01

The present proceedings of the European Nuclear Medicine Congress 1990 contain the opening addresses and the oral presentations of the meeting. The topics were as follows: Methods and basics (52 papers), cardiology (12 papers), neurology (13 papers), pulmonology (2 papers), gastroenterology (9 papers), nephrology (7 papers), osteology (8 papers), endocrinology (7 papers), pediatrics (5 papers), and oncology (12 papers). An author index and a subject index is found as a supplement to these proceedings. (MG) With 182 figs., 92 tabs

Current Status of Legislation on Dietary Products for Sportspeople in a European Framework

Directory of Open Access Journals (Sweden)

José Miguel Martínez-Sanz

2017-11-01

Full Text Available The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition and European (European Commission and European Food Safety Authority bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1 Advertising of any type of food and/or product; (2 Composition, labeling, and advertising of foods; (3 Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids.

Current Status of Legislation on Dietary Products for Sportspeople in a European Framework

Science.gov (United States)

Arranz, Laura; Ortiz-Moncada, Rocío

2017-01-01

The consumption of nutritional ergogenic aids is conditioned by laws/regulations, but standards/regulations vary between countries. The aim of this review is to explore legislative documents that regulate the use of nutritional ergogenic aids intended for sportspeople in a Spanish/European framework. A narrative review has been developed from official websites of Spanish (Spanish Agency of the Consumer, Food Safety, and Nutrition) and European (European Commission and European Food Safety Authority) bodies. A descriptive analysis of documents was performed. Eighteen legislative documents have been compiled in three sections: (1) Advertising of any type of food and/or product; (2) Composition, labeling, and advertising of foods; (3) Nutritional ergogenic aids. In spite of the existence of these legal documents, the regulation lacks guidance on the use/application of nutritional ergogenic aids for sportspeople. It is essential to prevent the introduction or dissemination of false, ambiguous, or inexact information and contents that induce an error in the receivers of the information. In this field, it is worth highlighting the roles of the European Food Safety Authority and the World Anti-Doping Agency, which provide information about consumer guidelines, prescribing practices, and recommendations for the prudent use of nutritional ergogenic aids. PMID:29117104

European Marine Information System. Eumaris; European Marine Information System. Eumaris

Energy Technology Data Exchange (ETDEWEB)

Caiaffa, E. [ENEA, Centro Ricerche Casaccia, Rome (Italy). Dipt. Ambiente

1999-07-01

The present paper summarises the activities developed by ETC/MCE, under European Environment Agency (EEA) contract, on the Geographic Information System. The aim of present paper is to introduce some general concepts about the Geographic Information Systems and to investigate the potential of G.I.S. as tool for the assessment of the European seas. Care has also been taken to explain the main technical and educational reasons that led to EUMARIS GIS birth, its evolution in the last year, till to its presentation at the Inter-Regional Forum of the European Conventions held in Venice. GIS is a technological tool phenomenon involving various aspects and different issues; many examples of thematic maps involving that different subjects are shown in the paper. [Italian] Il presente articolo riassume le attivita' svolte, nell'ambito del Geographic Information System, dall'ETC/MCE sotto contratto con l'Agenzia Europea per l'Ambiente (EEA) che ha sede a Copenhagen. Scopo del presente articolo e' quello di introdurre alcuni concetti generali sui Geographic Information System (GIS) e di dimostrare la possibilita' di utilizzare il GIS stesso come strumento per la valutazione dello stato dei mari dell'Europa. Si e' cercato di spiegare le principali ragioni tecniche che hanno portato alla nascita del progeto del GIS EUMARIS, alla sua realizzazione fino alla sua presentazione all'Inter-Regional Forum of European Conventions tenutosi a Venezia. Si e' cercato anche di mostrare come un GIS per sua natura e' uno strumento che coinvolge vari aspetti tecnologici e differenti tipi di dati; nell'articolo vengono mostrati diversi esempi di mappe tematiche che contengono tali differenti argomenti.

The EMBARC European bronchiectasis registry: Protocol for an international observational study

NARCIS (Netherlands)

Chalmers, J.D. (James D.); S. Aliberti (Stefano); Polverino, E. (Eva); Vendrell, M. (Montserrat); Crichton, M. (Megan); Loebinger, M. (Michael); Dimakou, K. (Katerina); Clifton, I. (Ian); M. van der Eerden (Menno); G. Rohde (Gernot); Murris-Espin, M. (Marlene); Masefield, S. (Sarah); Gerada, E. (Eleanor); Shteinberg, M. (Michal); F.C. Ringshausen (Felix C.); Haworth, C. (Charles); W.G. Boersma (Wim); Rademacher, J. (Jessica); Hill, A.T. (Adam T.); Aksamit, T. (Timothy); O’Donnell, A. (Anne); Morgan, L. (Lucy); B. Milenkovic (Branislava); Tramma, L. (Leandro); Neves, J. (Joao); Menendez, R. (Rosario); Paggiaro, P. (Perluigi); Botnaru, V. (Victor); Skrgat, S. (Sabina); R. Wilson (Richard); Goeminne, P. (Pieter); De Soyza, A. (Anthony); T. Welte; Torres, A. (Antoni); S. Elborn (Stuart); Blasi, F. (Francesco)

2016-01-01

textabstractBronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective,

Medicine, 1450-1620, and the history of science.

Science.gov (United States)

Siraisi, Nancy G

2012-09-01

History of science and history of medicine are today largely organized as distinct disciplines, though ones widely recognized as interrelated. Attempts to evaluate the extent and nature of their relation have reached varying conclusions, depending in part on the historical period under consideration. This essay examines some characteristics of European medicine from the fifteenth to the early seventeenth century and considers their relevance for the history of science. Attention is given to the range of interests and activities of individuals trained in or practicing medicine, to the impact of changes in natural philosophy, to the role of observation, description, and accumulation of information, and to the exchange of knowledge among the medical community.

Extract from IAEA's Resources Manual in Nuclear Medicine - Part 2. - Human Resources Development

International Nuclear Information System (INIS)

2003-01-01

The Nuclear Medicine Section of the International Atomic Energy Agency is now engaged in finalizing a reference manual in nuclear medicine, entitled, 'Resources Manual in Nuclear Medicine'. Several renowned professionals from all over the world, from virtually all fields of nuclear medicine have contributed to this manual. The World Journal of Nuclear Medicine will publish a series of extracts from this manual as previews. This is the second extract from the Resources Manual, Part-2 of the chapter on Human Resources Development. (author)

The Innovative Medicines Initiative moves translational immunology forward.

Science.gov (United States)

Goldman, Michel; Wittelsberger, Angela; De Magistris, Maria-Teresa

2013-02-01

The Innovative Medicines Initiative (IMI) was established in 2008 as a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations with the mission to promote the development of novel therapies through collaborative efforts based on the concept of pre-competitive research. Several consortia supported by IMI are dedicated to immuno-inflammatory disorders, immune-based biopharmaceuticals and vaccines. Herein, we present the key principles underlying IMI, briefly review the status of projects related to translational immunology, and present future topics of interest to immunologists.

Frontex and Non-refoulement: The International Responsibility of the European Union

DEFF Research Database (Denmark)

Mungianu, Roberta

Since the Frontex Border Agency's establishment in 2004, its activities have foregrounded the complexity and difficulty of protecting the human rights of those seeking access to the European Union. In this connection, protection from refoulement should be paramount in the Agency's work....... By navigating through the intricacies of Frontex's structure and working methods, this book answers abiding questions: which circumstances would trigger European Union responsibility if violations were to occur in Frontex's joint operations? What is the legal standing of the principle of non......-refoulement in relation to Frontex's activities? Can Frontex be entrusted with an exclusive search and rescue mandate? This book offers a theoretical and practical insight into the legislative intricacies of Frontex's work, examining the responsibility of the EU, and scrutinising the interaction of international law...