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Sample records for european medicines agency

  1. [Physician Involvement in the Activities of the European Medicines Agency].

    Science.gov (United States)

    Silva, Ivana

    2017-11-29

    For more than two decades of activity, the European Medicines Agency has been operating as part of a network with the national medicines agencies in Europe, bringing together - in its various scienti c committees and working groups - European experts on a wide range of topics related to quality assurance, safety and ef cacy of medicines. The work carried out within the European Medicines Agency activities and the conclusions reached at European level affect millions of citizens. The European Medicines Agency considers that it is of great importance to maintain, in a sustainable and consistent manner, the active participation of general practitioners, as well as other medical specialists, in the process of medicines' evaluation and supervision. This article summarizes how the participation of doctors and health professionals in general is promoted in the European Medicines Agency activities.

  2. European Medicines Agency initiatives and perspectives on pharmacogenomics

    Science.gov (United States)

    Ehmann, Falk; Caneva, Laura; Papaluca, Marisa

    2014-01-01

    Pharmacogenomics, the study of variations of DNA and RNA characteristics as related to drug response, has become an integral part of drug development and pharmacovigilance, as reflected by the incorporation of pharmacogenomic data in EU product information. In this short review article, we describe recent European Medicines Agency initiatives intended to support further the implementation of pharmacogenomics in drug development and surveillance so that patients and the public can benefit from advances in genomic science and technology. PMID:24433361

  3. European Medicines Agency, CAT Secretariat & US Food and Drug Administration.

    Science.gov (United States)

    2011-11-01

    The European Medicines Agency (EMA) and the Committee for Advanced Therapies (CAT) are responsible for reviewing applications for marketing authorization for Advanced Therapy Medicinal Products (ATMP), which include (stem) cell-based medicines, for the ATMP classification and certification procedure, and to provide scientific advice to developers of ATMPs. The CAT, an expert committee dedicated to ATMPs, was established by the Regulation (EC) No 1394/2007 on Advanced Therapies. The CAT came into operation in January 2009. ATMPs are defined in this Regulation as gene therapy and cell therapy medicinal products, and tissue-engineered products. The US FDA's Center for Biologics Evaluation and Research is responsible for ensuring the safety, purity, potency and effectiveness of many biologically derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products for the prevention, diagnosis and treatment of human diseases, conditions or injury. Human cells or tissue intended for implantation, transplantation, infusion or transfer into a human recipient are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).

  4. The European Medicines Agency's strategies to meet the challenges of Alzheimer disease.

    Science.gov (United States)

    Haas, Manuel; Mantua, Valentina; Haberkamp, Marion; Pani, Luca; Isaac, Maria; Butlen-Ducuing, Florence; Vamvakas, Spiros; Broich, Karl

    2015-04-01

    Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges.

  5. The European Medicines Agency's approval of new medicines for type 2 diabetes.

    Science.gov (United States)

    Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

    2018-05-08

    Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

  6. Readability assessment of package inserts of biological medicinal products from the European medicines agency website.

    Science.gov (United States)

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

    2014-07-01

    Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability. Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same package inserts in 2010. A total of 33 package inserts were selected and classified into five groups according to the type of medicine: monoclonal antibody-based products, cytokines, therapeutic enzymes, recombinant blood factors and other blood-related products, and recombinant hormones. The package inserts were downloaded from the European Medicines Agency website in 2007 and 2010. Readability was evaluated for the entire text of five of the six sections of the package inserts and for the 'Annex' when there was one. Three readability formulas were used: SMOG (Simple Measure of Gobbledygook) grade, Flesh-Kincaid grade level, and Szigriszt's perspicuity index. No significant differences were found between the readability results for the 2007 package inserts and those from 2010 according to any of the three readability indices studied (p>0.05). However, there were significant differences (preadability scores of the sections of the package inserts in both 2007 and 2010. The readability of the package inserts was above the recommended sixth grade reading level (ages 11-12) and may lead to difficulties of understanding for people with limited literacy. All the sections should be easy to read and, therefore, the readability of the medicine package inserts studied should be improved.

  7. Is There a Potential of Misuse for Quetiapine?: Literature Review and Analysis of the European Medicines Agency/European Medicines Agency Adverse Drug Reactions' Database.

    Science.gov (United States)

    Chiappini, Stefania; Schifano, Fabrizio

    2018-02-01

    A recent years' increase in both prescribing and availability of second-generation antipsychotics (SGAs) has been observed. According to the literature, typically made up by case studies/series, quetiapine seems to be the most commonly misused SGA, with both intranasal and intravenous intake modalities having been described. Another SGA that has been anecdotally reported to be misused is olanzapine. For these molecules, both a previous history of drug misuse and being an inmate have been described as factors associated with misuse. Hence, while providing here an updated literature review of the topic, we aimed at assessing all cases of quetiapine misuse/abuse/dependence/withdrawal as reported to the European Medicines Agency's EudraVigilance (EV) database; this was carried out in comparison with the reference drug olanzapine. All spontaneous, European Medicines Agency database reports relating to both quetiapine (2005-2016) and olanzapine (2004-2016) misuse/abuse/dependence/withdrawal issues were retrieved, and a descriptive analysis was performed. From the EV database, 18,112 (8.64% of 209,571) and 4178 (7.58% of 55,100) adverse drug reaction reports of misuse/abuse/dependence/withdrawal were associated with quetiapine and olanzapine, respectively. The resulting proportional reporting ratio values suggested that the misuse/abuse-, dependence-, and withdrawal-related adverse drug reactions were more frequently reported for quetiapine (1.07, 1.01, and 5.25, respectively) in comparison with olanzapine. Despite data collection limitations, present EV data may suggest that, at least in comparison with olanzapine, quetiapine misuse may be a cause for concern.

  8. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

    Science.gov (United States)

    Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

    2017-12-05

    The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  9. Gadolinium retention after administration of contrast agents based on linear chelators and the recommendations of the European Medicines Agency

    International Nuclear Information System (INIS)

    Dekkers, Ilona A.; Roos, Rick; Molen, Aart J. van der

    2018-01-01

    The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) earlier this year recommended to suspend some marketing authorisations for Gadolinium Containing Contrast Agents (GCCAs) based on linear chelators due to the potential risk of gadolinium retention in the human body. These recommendations have recently been re-evaluated by EMA's Committee for Medicinal Products for Human Use (CHMP), and confirmed the final opinion of the European Medicines Agency. This editorial provides an overview of the available GCCAs and summarises the recent evidence of gadolinium retention. Moreover, a critical appraisal of the strengths and limitations of the scientific evidence currently available on gadolinium retention is given. (orig.)

  10. The Small- and Medium-sized Enterprises Office (SME Office) at the European Medicines Agency.

    Science.gov (United States)

    Carr, M

    2010-01-01

    On 15 December 2005, the European Medicines Agency (EMEA) launched an "SME Office" to provide financial and administrative assistance to micro-, small- and medium-sized enterprises (SMEs), with the aim of promoting innovation and the development of new human and veterinary medicinal products by SMEs. According to current EU definition of an SME, companies with fewer than 250 employees, and an annual turnover of not more than 50 million euro or an annual balance sheet total of not more than 43 million euro, are eligible for assistance from the SME Office. Incentives available from the EMEA for SMEs, include: Administrative and procedural assistance from SME Office within the Agency; Fee reductions (90%) for scientific advice and inspections; Fee exemptions for certain administrative services (excluding parallel distribution); Deferral of the fee payable for an application for marketing authorisation or related inspection until after the grant of the marketing authorisation; Conditional fee exemption where scientific advice followed and marketing application is unsuccessful; Assistance with translations of the product information documents. At the end of May 2009, more than 380 companies from 21 countries across the European Economic Area (EEA) had SME status assigned by the EMEA. The large majority of companies are developing medicinal products for human use, 16 are veterinary companies, 15 companies are developing products for both human and veterinary use and 38 are regulatory consultants. Since the SME initiative started the Agency has processed more than 130 requests for scientific advice with fee reductions totalling of 6.9 million euro. Regulatory assistance has been provided to more than 170 companies and 12 companies have benefited from the SME translation service. Stakeholders have acknowledged the significant role the SME Office now plays as a service provider. In the period between January 2006 and June 2009, 34 applications for marketing authorization

  11. 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...

  12. Transparency Policies of the European Medicines Agency: Has the Paradigm Shifted?

    Science.gov (United States)

    Kim, Daria

    2017-08-01

    This article reflects on the state of play as regards access to non-summary clinical trial data in the European Union (EU). In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency (EMA) that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA. Under the applicable regulations, the scope of the accessible data depends on the interpretation of commercially confidential information-the notion derived from the exception to the fundamental right of access to documents. Accordingly, the analysis focuses on the application of this exception, taking into account the specifics of clinical data, the context in which disclosure occurs, and the interests that are at stake. The main complexity is found in defining the scope of the relevant and legitimate interests to be balanced when applying the exception. Overall, it is argued that the current regulatory framework does not provide a sufficient legal basis to support the objectives pursued by the EMA's policies. © The Author 2017. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

  13. Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

    Science.gov (United States)

    Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph

    2018-02-01

    The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

  14. 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.

  15. 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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    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

  20. 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.

  1. Status of Emergency Contraceptives in Europe One Year after the European Medicines Agency's Recommendation to Switch Ulipristal Acetate to Non-Prescription Status.

    Science.gov (United States)

    Italia, Salvatore; Brand, Helmut

    2016-01-01

    In November 2014, the European Medicines Agency (EMA) recommended switching the emergency contraceptive (EMC) ulipristal acetate to non-prescription status. This study's objective is to assess the current legal status of the two EMCs ulipristal acetate and levonorgestrel in Europe and to report on the development of sales figures for EMCs since they were made freely available. Health authorities were contacted in autumn 2015 and asked about the current status of EMCs and whether the sales figures had changed after a switch to non-prescription status. Additionally, data on consumption were collected in 18 German community pharmacies. As of November 2015, most countries in the European Union (EU) have followed the EMA recommendation. Hungary kept the prescription-only status. In Malta, EMC drugs are not authorized. Germany and Croatia switched levonorgestrel to non-prescription status as well. Of the EU candidate and European Free Trade Association countries, ulipristal acetate is available without prescription in Norway and Bosnia and Herzegovina only. Several countries reported an increase in EMC sales since the switch. An EMA recommendation can strongly contribute to the harmonization of a drug's legal status in the EU. In most European countries, ulipristal acetate and/or levonorgestrel are now freely available. © 2016 The Author(s) Published by S. Karger AG, Basel.

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

    DEFF Research Database (Denmark)

    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...

  3. 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).

    Science.gov (United States)

    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).

  4. 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.

  5. 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....

  6. 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...

  7. The European Space Agency's FESTIP initiative

    Science.gov (United States)

    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).

  8. Making Sense of the ‘Agency Programme’ in post-Lisbon Europe: Mapping European Agencies

    Directory of Open Access Journals (Sweden)

    Helena Margaretha Ekelund

    2012-07-01

    Full Text Available The institutional landscape of the EU has been transformed through the establishment of agencies and changes brought by the Lisbon Treaty. This article seeks to contribute to our conceptual and empirical understanding of European agencies post-Lisbon. It maps the current European agencies according to timing of establishment, size, functions, governance structures and financial arrangements, and discusses the findings in relation to studies and classifications of agencies in national settings. It shows that variations between different European agencies correspond to variations observed between agencies in national settings and argues that what is innovative is the political level at which they are created, not the agency type. Focusing on the functions, governance structure and financial arrangements of European agencies, it develops a classification model for European agencies. It concludes that there are four main types of agencies, distinguished by their formal functions and formal autonomy from the European Union’s core executive institutions.

  9. Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices

    Science.gov (United States)

    Tomić, Siniša; Filipović Sučić, Anita; Plazonić, Ana; Truban Žulj, Rajka; Macolić Šarinić, Viola; Čudina, Branka; Ilić Martinac, Adrijana

    2010-01-01

    Aim To present the activities of the Agency for Medicinal Products and Medical Devices in the first 5 years of its existence and to define its future challenges. Methods Main activities within the scope of the Agency as a regulatory authority were retrospectively analyzed for the period from 2004-2008. Data were collected from the Agency’s database and analyzed by descriptive statistics. Results The number of issued medicine authorizations rose from 240 in 2004 to 580 in 2008. The greatest number of new chemical and biological entities was approved in 2005. The greatest number of regular quality controls (n = 5833) and special quality controls was performed in 2008 (n = 589), while the greatest number of off-shelf quality controls (n = 132) was performed in 2007. The greatest number of medicine labeling irregularities was found in 2007 (n = 19) and of quality irregularities in 2004 (n = 9). The greatest number of adverse reactions was reported in 2008 (n = 1393). The number of registered medical devices rose from 213 in 2004 to 565 in 2008. Conclusion Over its 5 years of existence, the Agency has successfully coped with the constant increase in workload. In the future, as Croatia enters the European Union, the Agency will have to face the challenge of joining the integrated European regulatory framework. PMID:20401952

  10. 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.

  11. Traditional Mediterranean and European herbal medicines.

    Science.gov (United States)

    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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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.

  19. Regulation of medicinal plants for public health--European community monographs on herbal substances.

    Science.gov (United States)

    Knöss, Werner; Chinou, Ioanna

    2012-08-01

    The European legislation on medicinal products also addresses the medicinal use of products originating from plants. The objective of the legislation is to ensure the future existence of such products and to consider particular characteristics when assessing quality, efficacy, and safety. Two categories are defined: i) herbal medicinal products can be granted a marketing authorisation; and ii) traditional herbal medicinal products can be granted a registration based on their longstanding use if they are complying with a set of provisions ensuring their safe use. The Committee on Herbal Medicinal Products (HMPC) was established at the European Medicines Agency (EMA) to provide monographs and list entries on herbal substances and preparations thereof. Meanwhile, approx. 100 monographs have been published, which define a current scientific and regulatory standard for efficacy and safety of herbal substances and herbal preparations used in medicinal products. This harmonised European standard will facilitate the availability and adequate use of traditional herbal medicinal products and herbal medicinal products within the European Union. Consequent labelling shall also enable patients and health care professionals to differentiate medicinal products from other product categories like cosmetics, food supplements, and medical devices. Georg Thieme Verlag KG Stuttgart · New York.

  20. 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...

  1. 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...

  2. 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

  3. Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences.

    Science.gov (United States)

    Mochel, J P; Tyden, E; Hellmann, K; Vendrig, J C; Şenel, S; Dencker, L; Cristina, R T; Linden, H; Schmerold, I

    2018-06-01

    The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems. © 2017 John Wiley & Sons Ltd.

  4. A Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?

    Directory of Open Access Journals (Sweden)

    Nicola Allen

    2017-06-01

    Full Text Available Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe. Therefore, the aim of this study was to objectively assess and compare the national reimbursement recommendations of 9 European jurisdictions following European Medicines Agency (EMA recommendation for centralized marketing authorization.Methods: Using publicly available data and newly developed classification tools, this study appraised 9 European reimbursement systems by assessing HTA processes and the relationship between the regulatory, HTA and decision-making organizations. Each national HTA agency was classified according to two novel taxonomies. The System taxonomy, focuses on the position of the HTA agency within the national reimbursement system according to the relationship between the regulator, the HTA-performing agency, and the reimbursement decision-making coverage body. The HTA Process taxonomy distinguishes between the individual HTA agency's approach to economic and therapeutic evaluation and the inclusion of an independent appraisal step. The taxonomic groups were subsequently compared with national HTA recommendations.Results: This study identified European national reimbursement recommendations for 102 new active substances (NASs approved by the EMA from 2008 to 2012. These reimbursement recommendations were compared using a novel classification tool and identified alignment between the organizational structure of reimbursement systems (System taxonomy and HTA

  5. 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

  6. Driven by Expertise and Insulation? The Autonomy of European Regulatory Agencies

    Directory of Open Access Journals (Sweden)

    Christoph Ossege

    2015-03-01

    Full Text Available 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 ERAs with a potentially powerful means to increase autonomy. Relying on a rational institutionalist framework within which ERAs enjoy substantive discretion to pursue their goals, the study empirically compares three powerful ERAs—the European Medicines Agency, the European Chemicals Agency, and the European Food Safety Authority. Based on the analysis of 39 semi-structured expert interviews, findings show that expertise is a crucial explanation for ERAs’ substantive autonomy from the Commission. Towards research intensive private stakeholders, the role of expertise becomes less pronounced. Instead, ERAs are more successful in protecting their autonomy by engaging in the risk-averse interpretation of the regulatory framework and by adapting rules over time to adapt their needs: they engage in “procedural insulation”. Political salience provides a scope condition for ERAs to use expert knowledge and rulemaking competences more strategically—potentially undermining scientific quality.

  7. 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

  8. 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

  9. 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)

  10. 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

  11. 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)

  12. 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.

  13. 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.

  14. Regulatory structures for gene therapy medicinal products in the European Union.

    Science.gov (United States)

    Klug, Bettina; Celis, Patrick; Carr, Melanie; Reinhardt, Jens

    2012-01-01

    Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No. 1394/2007, the "ATMP Regulation" provides tailored regulatory principles for the evaluation and authorization of these innovative medicines. The majority of gene or cell therapy product development is carried out by academia, hospitals, and small- and medium-sized enterprises (SMEs). Thus, acknowledging the particular needs of these types of sponsors, the legislation also provides incentives for product development tailored to them. The European Medicines Agency (EMA) and, in particular, its Committee for Advanced Therapies (CAT) provide a variety of opportunities for early interaction with developers of ATMPs to enable them to have early regulatory and scientific input. An important tool to promote innovation and the development of new medicinal products by micro-, small-, and medium-sized enterprises is the EMA's SME initiative launched in December 2005 to offer financial and administrative assistance to smaller companies. The European legislation also foresees the involvement of stakeholders, such as patient organizations, in the development of new medicines. Considering that gene therapy medicinal products are developed in many cases for treatment of rare diseases often of monogenic origin, the involvement of patient organizations, which focus on rare diseases and genetic and congenital disorders, is fruitful. Two such organizations are represented in the CAT. Research networks play another important role in the development of gene therapy medicinal products. The European Commission is funding such networks through the EU Sixth Framework Program. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. 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

  16. 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.

  17. 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.

  18. 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

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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.

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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).

  8. 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.

  9. European Space Agency announces contest to "Name the Cluster Quartet"

    Science.gov (United States)

    2000-02-01

    1. Contest rules The European Space Agency (ESA) is launching a public competition to find the most suitable names for its four Cluster II space weather satellites. The quartet, which are currently known as flight models 5, 6, 7 and 8, are scheduled for launch from Baikonur Space Centre in Kazakhstan in June and July 2000. Professor Roger Bonnet, ESA Director of Science Programme, announced the competition for the first time to the European Delegations on the occasion of the Science Programme Committee (SPC) meeting held in Paris on 21-22 February 2000. The competition is open to people of all the ESA member states (*). Each entry should include a set of FOUR names (places, people, or things from history, mythology, or fiction, but NOT living persons). Contestants should also describe in a few sentences why their chosen names would be appropriate for the four Cluster II satellites. The winners will be those which are considered most suitable and relevant for the Cluster II mission. The names must not have been used before on space missions by ESA, other space organizations or individual countries. One winning entry per country will be selected to go to the Finals of the competition. The prize for each national winner will be an invitation to attend the first Cluster II launch event in mid-June 2000 with their family (4 persons) in a 3-day trip (including excursions to tourist sites) to one of these ESA establishments: ESRIN (near Rome, Italy): winners from France, Ireland, United Kingdom, Belgium. VILSPA (near Madrid, Spain): winners from The Netherlands, Norway, Sweden, Finland. ESTEC (near Amsterdam, The Netherlands): winners from Germany, Denmark, Switzerland, Austria. ESOC (in the Rhine Valley, Germany): winners from Italy, Spain , Portugal. During the first Cluster II launch event (June 2000) the chosen four names for the spacecraft will be announced. The grand prize will be: * a trip for the winner and family (4 people) to Paris where ESA's headquarters are

  10. 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…

  11. 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.

  12. 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...

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

    Science.gov (United States)

    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

  14. 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

  15. EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare), ECDC (European Centre for Disease Prevention and Control) and EMA (European Medicines Agency), 2013. Scientific Opinion on the possible risks posed by the Influenza A(H3N2v) virus for animal health and its potential spread and implications for animal and human health

    DEFF Research Database (Denmark)

    Bøtner, Anette

    of respiratory nature and follows a relatively mild course with fever, coughing and inappetence, similar to that of the endemic swine influenza viruses. Immunity resulting from vaccination with European vaccines may provide some cross-protection against infection with H3N2v virus whereas vaccines based on US...

  16. 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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  19. 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)

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

    Science.gov (United States)

    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.

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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...

  6. 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

  7. 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…

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

    Science.gov (United States)

    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.

  9. 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

  10. 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

  11. 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...

  12. 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.

  13. 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...

  14. 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...

  15. 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.

  16. 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.

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

    Science.gov (United States)

    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.

  18. 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

  19. 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....

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

    Science.gov (United States)

    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

  1. 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...

  2. 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

  3. 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...

  4. 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.

  5. [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.

  6. 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

  7. 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

  8. 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.

  9. Editorial: European Journal of Case Reports in Internal Medicine

    Directory of Open Access Journals (Sweden)

    John Kellett

    2014-02-01

    Full Text Available Modern medicine began in the last half of the nineteenth century when doctors started practising the scientific method at the bedside. However, in his presidential address to the Association of American Physicians in 1979 James Wyngaarden postulated that the clinical scientist was an endangered species. Several reasons for this have been suggested, including “the seductive incomes that now derive from procedure-based specialty medicine”. Others have suggested that it is simply because the things left to be discovered at bedside have become exhausted, and that all the big medical advances will now be made by high-powered institutions.

  10. 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

  11. Regulatory Anatomy: How "Safety Logics" Structure European Transplant Medicine.

    Science.gov (United States)

    Hoeyer, Klaus

    2015-07-01

    This article proposes the term "safety logics" to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of "safety" produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape.

  12. 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.

  13. 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.

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

    Science.gov (United States)

    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.

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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....

  20. 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

  1. 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.

  2. 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.

  3. 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

  4. 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...

  5. 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....

  6. 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.

  7. Exploiting the parallels - maximising the outreach potentials for the European Space Agency's Rosetta comet chaser mission

    Science.gov (United States)

    Pillinger, C. T.; Pillinger, J. M.

    2013-09-01

    The European Space Agency (ESA)'s comet chaser mission, Rosetta, has been more than a quarter of a century in coming to fruition. Whilst it might sound a long time humankind has been interested in comets for much longer. For over a thousand years depictions of comets have been appearing in Art 1 including many humorous cartoons 2. There are numerous cometary metaphors throughout literature. With this in mind we have recognised that there is a tremendous opportunity with comets to introduce science to different non-scientific audiences who would not necessarily believe they were interested in science. A similar approach was adopted with great success for the Beagle 2 involvement in ESA's Mars Express 3,4. By exploiting the perhaps sometimes less obvious connections to the Rosetta mission we hope to capture the attention of non-scientists and introduce them to science unawares - a case of a little sugar to help the medicine go down. It is our belief that the Rosetta mission has enormous potential for bringing science to the unconverted. We give here one example of a connection between Art and the Rosetta mission. By choosing the allegorical name Rosetta for its cometary mission, ESA have immediately invited comparison with the stone tablet which provided the key to translating the languages of ancient cultures, particularly Egyptian hieroglyphics. It is well known that a scientist, Thomas Young, foreign secretary of The Royal Society, made the break through which recognised the name Ptolemy in a cartouche on the Rosetta stone which can be seen today at the British Museum. The events concerning the 'capture' of the Rosetta stone were witnessed by scientists Sir William Hamilton (a renowned geophysicist as well as husband of Horatio Nelson's notorious mistress Lady Hamilton) and Edward Daniel Clarke, a geologist who would become first Professor of Mineralogy at Cambridge and an early meteoricist. Young's inspiration allowed Jean-Francois Champollion to decipher the

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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 ...

  13. [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.

  14. 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

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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.

  20. 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.

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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...

  8. 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.

  9. 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.

  10. 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)

  11. 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.

  12. [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.

  13. 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.

  14. 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

  15. 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

  16. 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.

  17. 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

  18. 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.)

  19. 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.)

  20. 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.)

  1. 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

  2. The International Atomic Energy Agency's activities in radiation medicine and cancer: promoting global health through diplomacy.

    Science.gov (United States)

    Deatsch-Kratochvil, Amanda N; Pascual, Thomas Neil; Kesner, Adam; Rosenblatt, Eduardo; Chhem, Rethy K

    2013-02-01

    Global health has been an issue of seemingly low political importance in comparison with issues that have direct bearing on countries' national security. Recently, health has experienced a "political revolution" or a rise in political importance. Today, we face substantial global health challenges, from the spread of infectious disease, gaps in basic maternal and child health care, to the globalization of cancer. A recent estimate states that the "overall lifetime risk of developing cancer (both sexes) is expected to rise from more than one in three to one in two by 2015." These issues pose significant threats to international health security. To successfully combat these grave challenges, the international community must embrace and engage in global health diplomacy, defined by scholars Thomas Novotny and Vicanne Adams as a political activity aimed at improving global health, while at the same time maintaining and strengthening international relations. The IAEA (International Atomic Energy Agency) is an international organization with a unique mandate to "accelerate and enlarge the contribution of atomic energy to peace, health, and prosperity throughout the world." This article discusses global health diplomacy, reviews the IAEA's program activities in human health by focusing on radiation medicine and cancer, and the peaceful applications of atomic energy within the context of global health diplomacy. Copyright © 2013 Canadian Association of Radiologists. Published by Elsevier Inc. All rights reserved.

  3. 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

  4. 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

  5. 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 ...

  6. 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

  7. 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.

  8. Building European Union capacity to manage transboundary crises : Network or lead-agency model?

    NARCIS (Netherlands)

    Boin, Arjen; Busuioc, Madalina; Groenleer, Martijn

    2014-01-01

    In recent years, the European continent has witnessed a substantial number of "transboundary crises" - crises that cross geographical borders and affect multiple policy domains. Nation states find it hard to deal with such crises by themselves. International cooperation, thus, becomes increasingly

  9. 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

  10. 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

  11. 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

  12. 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...

  13. The revision of the European blood directives: A major challenge for transfusion medicine.

    Science.gov (United States)

    Folléa, G; Aranko, K

    2015-08-01

    Using both patient-focused and donor-focused perspectives, to review the current EU blood directives, in order to derive proposals, in principle, for what should evolve during the revision process of these directives. Review of the EU blood directives in the light of scientific literature, related reports from the Directorate General Health and Consumers (DG SANTÉ), and from the Council of Europe (CoE). The analyses led us to present the main following proposals: developing voluntary unpaid donations: the directives should consider taking into consideration ethically acceptable forms of compensation consistent with altruistic donation (including plasma donations for fractionation); current expertise: more extensive utilization of the expertise of blood establishments and their consultants should be considered; donor selection: an evidence-based approach for basing donor deferral criteria on sound scientific evidence should be promoted; donor reactions: measures to prevent donor reactions and to make donations safer for the donors should also be included; quality control: The quality control requirements should relate to the Council of Europe Blood Guide specifications: these should become minimum standards (as is the case with monographs of the European Pharmacopeia), facilitating regular update of blood component lists and related specifications and compliance with the specifications; haemovigilance: because of reporting difficulties (e.g. lack of number of blood products transfused), the effectiveness of haemovigilance has so far been limited. This should lead appropriate bodies to investigate alternative or complementary ways to help improve patient safety, taking into consideration, in principle, patient blood management and the appropriate use of blood products. Furthermore, donor vigilance, which is still absent from the current directive should be included in a revised directive. These proposals for revising the current EU blood directives (if taken into

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

    Directory of Open Access Journals (Sweden)

    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

  15. 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.

  16. 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.

  17. Medicines

    Science.gov (United States)

    Medicines can treat diseases and improve your health. If you are like most people, you need to take medicine at some point in your life. You may need to take medicine every day, or you may only need to ...

  18. 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.

  19. Life sciences: Nuclear medicine, radiation biology, medical physics, 1980-1994. International Atomic Energy Agency Publications

    International Nuclear Information System (INIS)

    1994-11-01

    The catalogue lists all sales publications of the IAEA dealing with Life Sciences issued during the period 1980-1994. The publications are grouped in the following chapters: Nuclear Medicine (including Radiopharmaceuticals), Radiation Biology and Medical Physics (including Dosimetry)

  20. 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

  1. The EC4 European syllabus for post-graduate training in clinical chemistry and laboratory medicine

    DEFF Research Database (Denmark)

    Wieringa, Gijsbert; Zerah, Simone; Jansen, Rob

    2012-01-01

    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...

  2. 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.

  3. 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.

  4. 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.

  5. 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.)

  6. 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

  7. 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

  8. 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

  9. 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

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

    OpenAIRE

    Zelei, Tam?s; Moln?r, M?ria J.; Szegedi, M?rta; Kal?, Zolt?n

    2016-01-01

    Background 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. Objectives To e...

  11. 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.

  12. 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.

  13. 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

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

    LENUS (Irish Health Repository)

    Masud, Tahir

    2014-09-01

    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.

  15. 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

  16. 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

  17. 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

  18. Comparators (medicinal and non medicinal) for marketing authorization, for public health, for payers and at the European level.

    Science.gov (United States)

    Berdaï, Driss; Hotton, Jean-Michel; Lechat, Philippe

    2010-01-01

    clinical added value of the medicinal products evaluated. © 2010 Société Française de Pharmacologie et de Thérapeutique.

  19. Spirits and liqueurs in European traditional medicine: Their history and ethnobotany in Tuscany and Bologna (Italy).

    Science.gov (United States)

    Egea, Teresa; Signorini, Maria Adele; Bruschi, Piero; Rivera, Diego; Obón, Concepción; Alcaraz, Francisco; Palazón, José Antonio

    2015-12-04

    Fermented drinks, often alcoholic, are relevant in many nutritional, medicinal, social, ritual and religious aspects of numerous traditional societies. The use of alcoholic drinks of herbal extracts is documented in classical pharmacy since the 1st century CE and it is often recorded in ethnobotanical studies in Europe, particularly in Italy, where are used for a wide range of medicinal purposes. Formulations and uses represent a singular tradition which responds to a wide range of environmental and cultural factors. This research has two overarching aims To determine how long ancient uses, recipes and formulas for medicinal liqueurs from the pharmacopoeias and herbals of the 18th century persisted in later periods and their role in present ethnobotanical knowledge in areas of Tuscany and Emilia-Romagna (Italy). To trace other possible relationships among ancient and recent recipes of alcoholic beverages, from both popular and 'classic' (learned) sources in N-C Italy and neighboring areas. The review of herbals and classical pharmacopoeias, and ethnobotanical field work in Alta Valle del Reno (Tuscany and Emilia Romagna, Italy) were followed of a systematic study of ingredients and medicinal uses with multivariate analysis techniques. The multivariate analysis clearly shows six different styles of preparing medicinal alcoholic beverages: 1. The medicinal wine formulae by Dioscorides (1st century CE). 2. The pharmacopoeias of Florence and Bologna in the 18th century CE. 3. The formularies of Santa Maria Novella and Castiglione (19th and early 20th centuries CE). 4. The ethnobotanical data from Appennino Tosco-Emiliano; home-made formulations based almost exclusively on the use of local resources. 5. Traditional recipes from NE Italy and Austria. 6. Traditional recipes from NW Italy, Emilia, and Provence (France). A total of 54 ingredients (29 fruits) from 48 species are used in different combinations and proportions in Alta Valle del Reno (Italy) to produce

  20. Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries

    NARCIS (Netherlands)

    Leopold, Christine; Mantel-Teeuwisse, Aukje K; Vogler, Sabine; Valkova, Silvia; de Joncheere, Kees; Leufkens, Hubert G M; Wagner, Anita K; Ross-Degnan, Dennis; Laing, Richard

    2014-01-01

    OBJECTIVE: To identify pharmaceutical policy changes during the economic recession in eight European countries and to determine whether policy measures resulted in lower sales of, and less expenditure on, pharmaceuticals. METHODS: Information on pharmaceutical policy changes between 2008 and 2011 in

  1. 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

  2. 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.

  3. Results of the Simulation and Assimilation of Doppler Wind Lidar Observations in Preparation for European Space Agency's Aeolus Mission

    Science.gov (United States)

    McCarty, Will

    2011-01-01

    With the launch of the European Space Agency's Aeolus Mission in 2013, direct spaceborne measurements of vertical wind profiles are imminent via Doppler wind lidar technology. Part of the preparedness for such missions is the development of the proper data assimilation methodology for handling such observations. Since no heritage measurements exist in space, the Joint Observing System Simulation Experiment (Joint OSSE) framework has been utilized to generate a realistic proxy dataset as a precursor to flight. These data are being used for the development of the Gridpoint Statistical Interpolation (GSI) data assimilation system utilized at a number of centers through the United States including the Global Modeling and Assimilation Office (GMAO) at NASA/Goddard Space Flight Center and at the National Centers for Environmental Prediction (NOAA/NWS/NCEP) as an activity through the Joint Center for Satellite Data Assimilation. An update of this ongoing effort will be presented, including the methodology of proxy data generation, the limitations of the proxy data, the handling of line-of-sight wind measurements within the GSI, and the impact on both analyses and forecasts with the addition of the new data type.

  4. 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.)

  5. 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. A...... review open access publications and a final conference, with emphasis on current and future EU policies, addressing different target audiences....

  6. Prescribing of Antidiabetic Medicines before, during and after Pregnancy : A Study in Seven European Regions

    NARCIS (Netherlands)

    Charlton, Rachel A.; Klungsoyr, Kari; Neville, Amanda J.; Jordan, Sue; Pierini, Anna; de Jong-van den Berg, Lolkje T. W.; Bos, H. Jens; Puccini, Aurora; Engeland, Anders; Gini, Rosa; Davies, Gareth; Thayer, Daniel; Hansen, Anne V.; Morgan, Margery; Wang, Hao; McGrogan, Anita; Andersen, Anne-Marie Nybo; Dolk, Helen; Garne, Ester

    2016-01-01

    Aim To explore antidiabetic medicine prescribing to women before, during and after pregnancy in different regions of Europe. Methods A common protocol was implemented across seven databases in Denmark, Norway, The Netherlands, Italy (Emilia Romagna/Tuscany), Wales and the rest of the UK. Women with

  7. Mutual Transformation and the Development of European Policy Spaces : the Case of Medicine Licensing

    OpenAIRE

    Boris Hauray, Philippe Urfalino

    2006-01-01

    This article pleads for a systemic approach to European policy spaces formation. The termmutual transformation is used to underline three observations concerning how Europeanpolicy spaces are formed: 1) influence among the levels composing the Union runssimultaneously from Brussels to the lower levels, from the lower levels to the EUauthorities, and from country to country; 2) sources of change are both exogenous andendogenous; 3) the nature of the policies under study and the issues and inte...

  8. Policy interventions related to medicines: Survey of measures taken in European countries during 2010-2015.

    Science.gov (United States)

    Vogler, Sabine; Zimmermann, Nina; de Joncheere, Kees

    2016-12-01

    Policy-makers can use a menu of pharmaceutical policy options. This study aimed to survey these measures that were implemented in European countries between 2010 and 2015. We did bi-annual surveys with competent authorities of the Pharmaceutical Pricing and Reimbursement Information network. Additionally, we consulted posters produced by members of this network as well as further published literature. Information on 32 European countries (all European Union Member States excluding Luxembourg; Iceland, Norway, Serbia, Switzerland, Turkey) was included. 557 measures were reported between January 2010 and December 2015. The most frequently mentioned measure was price reductions and price freezes, followed by changes in patient co-payments, modifications related to the reimbursement lists and changes in distribution remuneration. Most policy measures were identified in Portugal, Greece, Belgium, France, the Czech Republic, Iceland, Spain and Germany. 22% of the measures surveyed could be classified as austerity. Countries that were strongly hit by the financial crisis implemented most policy changes, usually aiming to generate savings and briefly after the emergence of the crisis. Improvements in the economic situation tended to lead to an easing of austerity measures. Countries also implemented policies that aimed to enhance enforcement of existing measures and increase efficiency. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. A single European pharmaceutical market: Does maximum harmonization enhance medicinal product innovation?

    DEFF Research Database (Denmark)

    Faeh, Andrea Beata

    2013-01-01

    the orphan medicinal products scheme. The latter is subject to uniform Union rules specifically introduced to stimulate research and development and has led to the development of a number of new products. The article shows that the most radical positive integration depends to a large extent on the prospect...... – Innovation Union’ – market fragmentation to be one of the major causes of the lack of innovation. In order to establish if maximum harmonization benefits innovation, two distinct legal regimes in the pharmaceutical sector will be compared. The general rules for medicinal products are weighed against...... of it yielding revenue for the innovator. Hence, fuller harmonization can benefit innovation, but it is just as important, if not more important, to address other factors such as pricing, reimbursement and patent protection....

  10. Content of selected biologically active compounds in tea infusions of widely used European medicinal plants

    Czech Academy of Sciences Publication Activity Database

    Dadáková, E.; Vrchotová, Naděžda; Tříska, Jan

    2010-01-01

    Roč. 27, č. 1 (2010), s. 27-34 ISSN 1803-4403 R&D Projects: GA ČR(CZ) GA525/05/2546 Institutional research plan: CEZ:AV0Z60870520 Keywords : medicinal plant * Filipendula ulmaria * phenolic comupounds * rutin * quercetin Subject RIV: GM - Food Processing http://joa.zf.jcu.cz; http://versita.com/science/agriculture/joa

  11. 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.

  12. 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

  13. Design and Development of a Model to Simulate 0-G Treadmill Running Using the European Space Agency's Subject Loading System

    Science.gov (United States)

    Caldwell, E. C.; Cowley, M. S.; Scott-Pandorf, M. M.

    2010-01-01

    Develop a model that simulates a human running in 0 G using the European Space Agency s (ESA) Subject Loading System (SLS). The model provides ground reaction forces (GRF) based on speed and pull-down forces (PDF). DESIGN The theoretical basis for the Running Model was based on a simple spring-mass model. The dynamic properties of the spring-mass model express theoretical vertical GRF (GRFv) and shear GRF in the posterior-anterior direction (GRFsh) during running gait. ADAMs VIEW software was used to build the model, which has a pelvis, thigh segment, shank segment, and a spring foot (see Figure 1).the model s movement simulates the joint kinematics of a human running at Earth gravity with the aim of generating GRF data. DEVELOPMENT & VERIFICATION ESA provided parabolic flight data of subjects running while using the SLS, for further characterization of the model s GRF. Peak GRF data were fit to a linear regression line dependent on PDF and speed. Interpolation and extrapolation of the regression equation provided a theoretical data matrix, which is used to drive the model s motion equations. Verification of the model was conducted by running the model at 4 different speeds, with each speed accounting for 3 different PDF. The model s GRF data fell within a 1-standard-deviation boundary derived from the empirical ESA data. CONCLUSION The Running Model aids in conducting various simulations (potential scenarios include a fatigued runner or a powerful runner generating high loads at a fast cadence) to determine limitations for the T2 vibration isolation system (VIS) aboard the International Space Station. This model can predict how running with the ESA SLS affects the T2 VIS and may be used for other exercise analyses in the future.

  14. 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.

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

    DEFF Research Database (Denmark)

    Mangin, P; Bonbled, F; Väli, M

    2015-01-01

    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...... 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...

  16. 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

  17. 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.

  18. Reproductive medicine and the law: egg donation in Germany, Spain and other European countries.

    Science.gov (United States)

    Romeo Casabona, Carlos María; Paslack, Rainer; Simon, Jörgen W

    2013-01-01

    This paper analyzes the key legal issues raised by Reproductive Medicine practiced in Europe, with special attention to the rules prevailing in countries such as Germany and Spain. Thus, the paper involves a detailed study of the regulation in force in those countries, comparing their solutions with the rules adopted in other EU countries. It also highlights the high risk of com-modification in oocyte donation. In light of this, the differences between the laws of EU countries -some of them, very restrictive with prohibitions or requirements for recipient women and others more permissive with the use of reproductive technologies- can lead to a "reproductive tourism" between countries, as indeed is happening nowadays.

  19. Prescribing of Antidiabetic Medicines before, during and after Pregnancy: A Study in Seven European Regions.

    Science.gov (United States)

    Charlton, Rachel A; Klungsøyr, Kari; Neville, Amanda J; Jordan, Sue; Pierini, Anna; de Jong-van den Berg, Lolkje T W; Bos, H Jens; Puccini, Aurora; Engeland, Anders; Gini, Rosa; Davies, Gareth; Thayer, Daniel; Hansen, Anne V; Morgan, Margery; Wang, Hao; McGrogan, Anita; Nybo Andersen, Anne-Marie; Dolk, Helen; Garne, Ester

    2016-01-01

    To explore antidiabetic medicine prescribing to women before, during and after pregnancy in different regions of Europe. A common protocol was implemented across seven databases in Denmark, Norway, The Netherlands, Italy (Emilia Romagna/Tuscany), Wales and the rest of the UK. Women with a pregnancy starting and ending between 2004 and 2010, (Denmark, 2004-2009; Norway, 2005-2010; Emilia Romagna, 2008-2010), which ended in a live or stillbirth, were identified. Prescriptions for antidiabetic medicines issued (UK) or dispensed (non-UK) during pregnancy and/or the year before or year after pregnancy were identified. Prescribing patterns were compared across databases and over calendar time. 1,082,673 live/stillbirths were identified. Pregestational insulin prescribing during the year before pregnancy ranged from 0.27% (CI95 0.25-0.30) in Tuscany to 0.45% (CI95 0.43-0.47) in Norway, and increased between 2004 and 2009 in all countries. During pregnancy, insulin prescribing peaked during the third trimester and increased over time; third trimester prescribing was highest in Tuscany (2.2%) and lowest in Denmark (0.5%). Of those prescribed an insulin during pregnancy, between 50.5% in Denmark and 88.8% in the Netherlands received an insulin analogue alone or in combination with human insulin, this proportion increasing over time. Oral products were mainly metformin and prescribing was highest in the 3 months before pregnancy. Metformin use during pregnancy increased in some countries. Pregestational diabetes is increasing in many areas of Europe. There is considerable variation between and within countries in the choice of medication for treating pregestational diabetes in pregnancy, including choice of insulin analogues and oral antidiabetics, and very large variation in the treatment of gestational diabetes despite international guidelines.

  20. Prescribing of Antidiabetic Medicines before, during and after Pregnancy: A Study in Seven European Regions.

    Directory of Open Access Journals (Sweden)

    Rachel A Charlton

    Full Text Available To explore antidiabetic medicine prescribing to women before, during and after pregnancy in different regions of Europe.A common protocol was implemented across seven databases in Denmark, Norway, The Netherlands, Italy (Emilia Romagna/Tuscany, Wales and the rest of the UK. Women with a pregnancy starting and ending between 2004 and 2010, (Denmark, 2004-2009; Norway, 2005-2010; Emilia Romagna, 2008-2010, which ended in a live or stillbirth, were identified. Prescriptions for antidiabetic medicines issued (UK or dispensed (non-UK during pregnancy and/or the year before or year after pregnancy were identified. Prescribing patterns were compared across databases and over calendar time.1,082,673 live/stillbirths were identified. Pregestational insulin prescribing during the year before pregnancy ranged from 0.27% (CI95 0.25-0.30 in Tuscany to 0.45% (CI95 0.43-0.47 in Norway, and increased between 2004 and 2009 in all countries. During pregnancy, insulin prescribing peaked during the third trimester and increased over time; third trimester prescribing was highest in Tuscany (2.2% and lowest in Denmark (0.5%. Of those prescribed an insulin during pregnancy, between 50.5% in Denmark and 88.8% in the Netherlands received an insulin analogue alone or in combination with human insulin, this proportion increasing over time. Oral products were mainly metformin and prescribing was highest in the 3 months before pregnancy. Metformin use during pregnancy increased in some countries.Pregestational diabetes is increasing in many areas of Europe. There is considerable variation between and within countries in the choice of medication for treating pregestational diabetes in pregnancy, including choice of insulin analogues and oral antidiabetics, and very large variation in the treatment of gestational diabetes despite international guidelines.

  1. 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

  2. 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...

  3. Sea Surface Temperature for Climate Applications: A New Dataset from the European Space Agency Climate Change Initiative

    Science.gov (United States)

    Merchant, C. J.; Hulley, G. C.

    2013-12-01

    There are many datasets describing the evolution of global sea surface temperature (SST) over recent decades -- so why make another one? Answer: to provide observations of SST that have particular qualities relevant to climate applications: independence, accuracy and stability. This has been done within the European Space Agency (ESA) Climate Change Initative (CCI) project on SST. Independence refers to the fact that the new SST CCI dataset is not derived from or tuned to in situ observations. This matters for climate because the in situ observing network used to assess marine climate change (1) was not designed to monitor small changes over decadal timescales, and (2) has evolved significantly in its technology and mix of types of observation, even during the past 40 years. The potential for significant artefacts in our picture of global ocean surface warming is clear. Only by having an independent record can we confirm (or refute) that the work done to remove biases/trend artefacts in in-situ datasets has been successful. Accuracy is the degree to which SSTs are unbiased. For climate applications, a common accuracy target is 0.1 K for all regions of the ocean. Stability is the degree to which the bias, if any, in a dataset is constant over time. Long-term instability introduces trend artefacts. To observe trends of the magnitude of 'global warming', SST datasets need to be stable to <5 mK/year. The SST CCI project has produced a satellite-based dataset that addresses these characteristics relevant to climate applications. Satellite radiances (brightness temperatures) have been harmonised exploiting periods of overlapping observations between sensors. Less well-characterised sensors have had their calibration tuned to that of better characterised sensors (at radiance level). Non-conventional retrieval methods (optimal estimation) have been employed to reduce regional biases to the 0.1 K level, a target violated in most satellite SST datasets. Models for

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

    Directory of Open Access Journals (Sweden)

    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.

  5. Does medicine still show an unresolved discrimination against women? Experience in two European university hospitals.

    Science.gov (United States)

    Santamaría, A; Merino, A; Viñas, O; Arrizabalaga, P

    2009-02-01

    Have invisible barriers for women been broken in 2007, or do we still have to break through medicine's glass ceiling? Data from two of the most prestigious university hospitals in Barcelona with 700-800 beds, Hospital Clínic (HC) and Hospital de la Santa Creu i Sant Pau (HSCSP) address this issue. In the HSCSP, 87% of the department chairs are men and 85% of the department unit chiefs are also men. With respect to women, only 5 (13%) are in the top position (department chair) and 4 (15%) are department unit chiefs. Similar statistics are also found at the HC: 87% of the department chairs and 89% of the department unit chiefs are men. Currently, only 6 women (13%) are in the top position and 6 (11%) are department unit chiefs. Analysis of the 2002 data of internal promotions in HC showed that for the first level (senior specialist) sex distribution was similar. Nevertheless, for the second level (consultant) only 25% were women, and for the top level (senior consultant) only 8% were women. These proportions have not changed in 2007 in spite of a 10% increase in leadership positions during this period. Similar proportions were found in HSCSP where 68% of the top promotions were held by men. The data obtained from these two different medical institutions in Barcelona are probably representative of other hospitals in Spain. It would be ethically desirable to have males and females in leadership positions in the medical profession.

  6. 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.

  7. 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.

  8. 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

  9. 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.

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

    Directory of Open Access Journals (Sweden)

    Sarayu A Pai

    2016-01-01

    Interpretation & conclusions: 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.

  11. 77 FR 52744 - Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop

    Science.gov (United States)

    2012-08-30

    ... pharmaceutical, biotechnology, and device companies, as well as academics. Date and Time: The meeting will be... need to undergo a second registration process with FDA, and are expected to bring information for at... condition in order to discuss the processes for putting together an application. In addition, participants...

  12. 78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

    Science.gov (United States)

    2013-08-21

    ..., and the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology... treatment of a rare disease or condition in order to discuss the processes for putting together an...

  13. 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.)

  14. 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

  15. Quality Assurance in the European Higher Education Area: The Emergence of a German Market for Quality Assurance Agencies

    Science.gov (United States)

    Serrano-Velarde, Kathia E.

    2008-01-01

    Most European countries have introduced systematic quality assurance as part of an overall governance reform aimed at enhancing universities' autonomy. Researchers and economic entrepreneurs tend, however, to underestimate the political dimension of accreditation and evaluation when they consider the contribution of quality assurance to the…

  16. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM) on PET imaging of atherosclerosis

    Energy Technology Data Exchange (ETDEWEB)

    Bucerius, Jan [Maastricht University Medical Center, Department of Nuclear Medicine, Maastricht (Netherlands); Maastricht University Medical Center, Cardiovascular Research Institute Maastricht (CARIM), Maastricht (Netherlands); University Hospital RWTH Aachen, RWTH Aachen, Department of Nuclear Medicine, Aachen (Germany); Maastricht University Medical Center (MUMC), Department of Nuclear Medicine and Cardiovascular Research Institute (CARIM), P. Debyelaan 25, HX, Maastricht (Netherlands); Hyafil, Fabien [Bichat University Hospital, Inserm 1148, DHU FIRE, Assistance Publique - Hopitaux de Paris, Department of Nuclear Medicine, Paris (France); Klinikum rechts der Isar, Technische Universitaet Muenchen, Department of Nuclear Medicine, Munich (Germany); Verberne, Hein J. [University of Amsterdam, Department of Nuclear Medicine, Academic Medical Center, Amsterdam (Netherlands); Slart, Riemer H.J.A. [University of Groningen, Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen (Netherlands); University of Twente, Department of Biomedical Photonic Imaging, Faculty of Science and Technology, Enschede (Netherlands); Lindner, Oliver [Heart and Diabetes Center NRW, Nuclear Medicine and Molecular Imaging, Institute of Radiology, Bad Oeynhausen (Germany); Sciagra, Roberto [University of Florence, Nuclear Medicine Unit, Department of Experimental and Clinical Biomedical Sciences, Florence (Italy); Agostini, Denis [Normandie Universite, Department of Nuclear Medicine, CHU Cote de Nacre, Caen (France); Uebleis, Christopher [Ludwig-Maximilians Universitaet Muenchen, Department of Clinical Radiology, Muenchen (Germany); Gimelli, Alessia [Fondazione Toscana Gabriele Monasterio, Pisa (Italy); Hacker, Marcus [Medical University Vienna, Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided therapy, Vienna (Austria); Collaboration: on behalf of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM)

    2016-04-15

    Cardiovascular diseases are the leading cause of death not only in Europe but also in the rest of the World. Preventive measures, however, often fail and cardiovascular disease may manifest as an acute coronary syndrome, stroke or even sudden death after years of silent progression. Thus, there is a considerable need for innovative diagnostic and therapeutic approaches to improve the quality of care and limit the burden of cardiovascular diseases. During the past 10 years, several retrospective and prospective clinical studies have been published using {sup 18}F-fluorodeoxyglucose (FDG) positron emission tomography (PET) to quantify inflammation in atherosclerotic plaques. However, the current variety of imaging protocols used for vascular (arterial) imaging with FDG PET considerably limits the ability to compare results between studies and to build large multicentre imaging registries. Based on the existing literature and the experience of the Members of the European Association of Nuclear Medicine (EANM) Cardiovascular Committee, the objective of this position paper was to propose optimized and standardized protocols for imaging and interpretation of PET scans in atherosclerosis. These recommendations do not, however, replace the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual study protocols used and the individual patient, in consultation with the patient and, where appropriate and necessary, the patient's guardian or carer. These recommendations suffer from the absence of conclusive evidence on many of the recommendations. Therefore, they are not intended and should not be used as ''strict guidelines'' but should, as already mentioned, provide a basis for standardized clinical atherosclerosis PET imaging protocols, which are subject to further and continuing evaluation and improvement. However, this EANM position paper might indeed be a first step towards &apos

  17. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM) on PET imaging of atherosclerosis

    International Nuclear Information System (INIS)

    Bucerius, Jan; Hyafil, Fabien; Verberne, Hein J.; Slart, Riemer H.J.A.; Lindner, Oliver; Sciagra, Roberto; Agostini, Denis; Uebleis, Christopher; Gimelli, Alessia; Hacker, Marcus

    2016-01-01

    Cardiovascular diseases are the leading cause of death not only in Europe but also in the rest of the World. Preventive measures, however, often fail and cardiovascular disease may manifest as an acute coronary syndrome, stroke or even sudden death after years of silent progression. Thus, there is a considerable need for innovative diagnostic and therapeutic approaches to improve the quality of care and limit the burden of cardiovascular diseases. During the past 10 years, several retrospective and prospective clinical studies have been published using 18 F-fluorodeoxyglucose (FDG) positron emission tomography (PET) to quantify inflammation in atherosclerotic plaques. However, the current variety of imaging protocols used for vascular (arterial) imaging with FDG PET considerably limits the ability to compare results between studies and to build large multicentre imaging registries. Based on the existing literature and the experience of the Members of the European Association of Nuclear Medicine (EANM) Cardiovascular Committee, the objective of this position paper was to propose optimized and standardized protocols for imaging and interpretation of PET scans in atherosclerosis. These recommendations do not, however, replace the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual study protocols used and the individual patient, in consultation with the patient and, where appropriate and necessary, the patient's guardian or carer. These recommendations suffer from the absence of conclusive evidence on many of the recommendations. Therefore, they are not intended and should not be used as ''strict guidelines'' but should, as already mentioned, provide a basis for standardized clinical atherosclerosis PET imaging protocols, which are subject to further and continuing evaluation and improvement. However, this EANM position paper might indeed be a first step towards &apos

  18. 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...

  19. Bioclim Deliverable D2: consolidation of needs of the European waste management agencies and the regulator of the consortium

    International Nuclear Information System (INIS)

    2002-01-01

    The nature of long-lived radioactive wastes is that they present a radiological hazard over a period of time that is extremely long compared with the timescale over which the engineered protection systems and institutional management of a disposal, or long-term storage, facility can be guaranteed. On such timescales, it is generally assumed that radionuclides may be slowly released from the containment system, migrating via geosphere pathways until they reach the accessible environment. Hence, there is a need to study the evolution of the environment external to the disposal system and the ways in which this might impact on its long-term radiological safety performance, for example in terms of influences on the migration and accumulation of radionuclides. One method that can contribute to understanding of how the biosphere might change in the future is to develop an awareness of how the characteristics of the region of interest have changed up to the present day as a result of the influences of past climate and environmental changes. It may then be possible to justify the use of environmental conditions that have occurred in the past as indicators of characteristics in the future, according to scientific understanding of the main influences on projected future change over the timescales relevant to the assessment. An important part of the basic understanding that underpins long-term radiological safety assessments is therefore information collected from site characterisation surveys; such data, coupled with palaeo-climate and palaeo-ecological records at regional and global scales, can then be used to reconstruct the progression of past environmental change over periods of time comparable with those of interest to the assessment. This report summarises work undertaken by national agencies from four European countries (France, Spain, United Kingdom and Czech Republic) to develop site and region-specific descriptions of environmental change during the Quaternary

  20. 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

  1. Highlights Lecture of the European Association of Nuclear Medicine and the World Federation of Nuclear Medicine and Biology Congress, Berlin 1998. Where next and how?

    International Nuclear Information System (INIS)

    Britton, K.E.

    1998-01-01

    Nuclear medicine benefits not only the people of developed countries but also those who are in developing or deteriorating countries. The combination of diagnostic imaging, tissue characterisation, function measurement and targeted therapy is powerful and cost-effective. This congress provides a sample of nuclear medicine's contribution to the world. (orig.)

  2. 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...

  3. 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.

  4. 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.

  5. Hurdles in tissue engineering/regenerative medicine product commercialization: a pilot survey of governmental funding agencies and the financial industry.

    Science.gov (United States)

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

    2012-11-01

    The Tissue Engineering and Regenerative Medicine International Society of the Americas (TERMIS-AM) Industry Committee conducted a semiquantitative opinion survey in 2010 to delineate potential hurdles to commercialization perceived by the TERMIS constituency groups that participate in the stream of technology commercialization (academia, start-up companies, development-stage companies, and established companies). A significant hurdle identified consistently by each group was access to capital for advancing potential technologies into development pathways leading to commercialization. A follow-on survey was developed by the TERMIS-AM Industry Committee to evaluate the financial industry's perspectives on investing in regenerative medical technologies. The survey, composed of 15 questions, was developed and provided to 37 investment organizations in one of three sectors (governmental, private, and public investors). The survey was anonymous and confidential with sector designation the only identifying feature of each respondent's organization. Approximately 80% of the survey was composed of respondents from the public (n=14) and private (n=15) sectors. Each respondent represents one investment organization with the potential of multiple participants participating to form the organization's response. The remaining organizations represented governmental agencies (n=8). Results from this survey indicate that a high percentage ($2MM into regenerative medical companies at the different stages of a company's life cycle. Investors recognized major hurdles to this emerging industry, including regulatory pathway, clinical translation, and reimbursement of these new products. Investments in regenerative technologies have been cyclical over the past 10-15 years, but investors recognized a 1-5-year investment period before the exit via Merger and Acquisition (M&A). Investors considered musculoskeletal products and their top technology choice with companies in the clinical stage

  6. 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

  7. The trigger values in the environmental risk assessment for (veterinary) medicines in the European Union: a critical appraisal

    NARCIS (Netherlands)

    Montforts MHMM; SEC

    2005-01-01

    A critical appraisal of the data used for the establishment of the trigger values for the exposure of the aquatic environment to human medicines and the terrestrial environment to veterinary medicines leads to the recommendation to change these values. The (draft) technical guidance documents in

  8. 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

  9. Which benefits and limits derive from ESA membership for European Countries owning ;medium-sized; space agencies?

    Science.gov (United States)

    Petroni, Giorgio; Bigliardi, Barbara; Galati, Francesco; Petroni, Alberto

    2018-01-01

    This study investigates the benefits and limits deriving from membership with ESA of six medium-sized space agencies in terms of strengthening and development (or not) of space technologies, as well as their contribution to the growth of productive activities and to the increase of services for citizens. This research contributes to the more general issue of the usefulness of space activities, not only for scientific or military-political purposes but also for economic and social development. Results show that, on the one hand, the membership with ESA has allowed smaller Countries to access space programs, to develop advanced technologies and to support the growth of their firms in some significant markets, but, on the other hand, the membership has also limited the access to space to few companies, without encouraging the broad dissemination of technological knowledge.

  10. Collaborative models for the joint production of core health technology assessments: negative and positive aspects for the joint work of different European agencies.

    Science.gov (United States)

    Lo Scalzo, Alessandra; Vicari, Nicola; Corio, Mirella; Perrini, Maria Rosaria; Jefferson, Tom; Gillespie, Francesca; Cerbo, Marina

    2014-11-01

    The purpose of the European network for Health Technology Assessment (EUnetHTA) is to make HTA agencies collaborate sharing methods and tools thus avoiding duplication of evaluative efforts and allowing resource savings. From 2010 to 2012, the activities of the network were carried out through EUnetHTA Joint Action 1 and Work Package 4 Strand B aimed at producing two Core HTAs with two main objectives: to test the Web based Core model and the collaborative working models. Our objective in this article is to give an historical record of the Work Package activities highlighting what worked and what did not in the collaboration of researchers' groups coming from different agencies. A retrospective description of all the steps for the joint production of the two Core HTAs is provided starting from the first step of selecting technologies of common interest. Primary researchers' views on the whole process have been collected through a semi-structured telephonic interview supported by a questionnaire. Coordinators views were gathered during internal meetings and validated. Majority of respondents thought topic selection procedure was not clear and well managed. About collaborative models, small groups were seen to enable more exchange, whatever the model. According to coordinators, loss of expertise and experience during the production process, different languages, and novelty of the Online Tool were main barriers. Lessons learned from this first experience in Joint Action 1 paved the path for the collaboration in Joint Action 2, as it allowed enhancements and changes in models of collaborations and coordination.

  11. Reporting nuclear cardiology: a joint position paper by the European Association of Nuclear Medicine (EANM) and the European Association of Cardiovascular Imaging (EACVI).

    Science.gov (United States)

    Trägårdh, Elin; Hesse, Birger; Knuuti, Juhani; Flotats, Albert; Kaufmann, Philipp A; Kitsiou, Anastasia; Hacker, Marcus; Verberne, Hein J; Edenbrandt, Lars; Delgado, Victoria; Donal, Erwan; Edvardsen, Thor; Galderisi, Maurizio; Habib, Gilbert; Lancellotti, Patrizio; Nieman, Koen; Rosenhek, Raphael; Agostini, Denis; Gimelli, Alessia; Lindner, Oliver; Slart, Riemert; Ubleis, Christopher

    2015-03-01

    The report of an imaging procedure is a critical component of an examination, being the final and often the only communication from the interpreting physician to the referring or treating physician. Very limited evidence and few recommendations or guidelines on reporting imaging studies are available; therefore, an European position statement on how to report nuclear cardiology might be useful. The current paper combines the limited existing evidence with expert consensus, previously published recommendations as well as current clinical practices. For all the applications discussed in this paper (myocardial perfusion, viability, innervation, and function as acquired by single photon emission computed tomography and positron emission tomography or hybrid imaging), headings cover laboratory and patient demographics, clinical indication, tracer administration and image acquisition, findings, and conclusion of the report. The statement also discusses recommended terminology in nuclear cardiology, image display, and preliminary reports. It is hoped that this statement may lead to more attention to create well-written and standardized nuclear cardiology reports and eventually lead to improved clinical outcome. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  12. Hybrid cardiac imaging using PET/MRI: a joint position statement by the European Society of Cardiovascular Radiology (ESCR) and the European Association of Nuclear Medicine (EANM).

    Science.gov (United States)

    Nensa, Felix; Bamberg, Fabian; Rischpler, Christoph; Menezes, Leon; Poeppel, Thorsten D; la Fougère, Christian; Beitzke, Dietrich; Rasul, Sazan; Loewe, Christian; Nikolaou, Konstantin; Bucerius, Jan; Kjaer, Andreas; Gutberlet, Matthias; Prakken, Niek H; Vliegenthart, Rozemarijn; Slart, Riemer H J A; Nekolla, Stephan G; Lassen, Martin L; Pichler, Bernd J; Schlosser, Thomas; Jacquier, Alexis; Quick, Harald H; Schäfers, Michael; Hacker, Marcus

    2018-05-02

    Positron emission tomography (PET) and magnetic resonance imaging (MRI) have both been used for decades in cardiovascular imaging. Since 2010, hybrid PET/MRI using sequential and integrated scanner platforms has been available, with hybrid cardiac PET/MR imaging protocols increasingly incorporated into clinical workflows. Given the range of complementary information provided by each method, the use of hybrid PET/MRI may be justified and beneficial in particular clinical settings for the evaluation of different disease entities. In the present joint position statement, we critically review the role and value of integrated PET/MRI in cardiovascular imaging, provide a technical overview of cardiac PET/MRI and practical advice related to the cardiac PET/MRI workflow, identify cardiovascular applications that can potentially benefit from hybrid PET/MRI, and describe the needs for future development and research. In order to encourage its wide dissemination, this article is freely accessible on the European Radiology and European Journal of Hybrid Imaging web sites. • Studies and case-reports indicate that PET/MRI is a feasible and robust technology. • Promising fields of application include a variety of cardiac conditions. • Larger studies are required to demonstrate its incremental and cost-effective value. • The translation of novel radiopharmaceuticals and MR-sequences will provide exciting new opportunities.

  13. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

    DEFF Research Database (Denmark)

    Gluud, Christian; Kubiak, Christine; Whitfield, Kate

    2012-01-01

    In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.......In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe....

  14. Tartu as the Eastern Outpost of European Medicine in the First Half of the 17th Century

    Directory of Open Access Journals (Sweden)

    Kaarina Rein

    2014-06-01

    Full Text Available The history of medicine in Tartu begins with medieval monastic Church, which were probably founded in the middle of the 13th century. The physician who arrived from Tallinn. Up to the beginning of the 17th century, the owners of the pharmacy were the only representatives of academic medicine in Tartu. Academic medical education in Tartu had its beginnings with the academic gymnasium founded in 1630 and the university founded in 1632. One of the three higher faculties at the University of Tartu at that time was the Faculty of Medicine. It was planned to have two professorships, although in reality only one professor of medicine was employed. The model of the University of Paris demanded that all “proper” universities must have a medical faculty. There were very few students studying at the Faculty of Medicine in Tartu in the 17th century. Only two names—David Cunitius and Olaus Oestenius—could be mentioned from among those who studied medicine at Academia Gustaviana and were later active as physicians. There were also students who studied in some other faculty in Tartu and However, the Swedish University of Tartu can be considered an important centre of early modern medical thought in the Eastern Europe. The article tries to give some idea about the medical situation in Tartu before the founding of the University of Tartu and during its early period of existence. The task is to investigate whether the academic medicine of the th century has introduced any changes into the history of medicine of Tartu.

  15. 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.

  16. Impact of animal health and welfare planning on medicine use, herd health and production in European organic dairy farms

    DEFF Research Database (Denmark)

    Ivemeyer, S; Smolders, G; Brinkmann, J

    2012-01-01

    medicine use through animal health and welfare planning (AHWP). Medicine use (excluding complementary treatments such as homeopathic remedies) was assessed as the total number of treatments and as the number of treatments of various disease categories (udder, fertility, metabolism, locomotion and others...... acidosis and imbalanced energy supply, respectively. Calving interval was used as an indicator for fertility. Milk recording data and treatment data were retrospectively collected for a one year period before and after the first farm visit. Focus areas of animal health and welfare plans were either...

  17. What is a food and what is a medicinal product in the European Union? Use of the benchmark dose (BMD) methodology to define a threshold for "pharmacological action".

    Science.gov (United States)

    Lachenmeier, Dirk W; Steffen, Christian; el-Atma, Oliver; Maixner, Sibylle; Löbell-Behrends, Sigrid; Kohl-Himmelseher, Matthias

    2012-11-01

    The decision criterion for the demarcation between foods and medicinal products in the EU is the significant "pharmacological action". Based on six examples of substances with ambivalent status, the benchmark dose (BMD) method is evaluated to provide a threshold for pharmacological action. Using significant dose-response models from literature clinical trial data or epidemiology, the BMD values were 63mg/day for caffeine, 5g/day for alcohol, 6mg/day for lovastatin, 769mg/day for glucosamine sulfate, 151mg/day for Ginkgo biloba extract, and 0.4mg/day for melatonin. The examples for caffeine and alcohol validate the approach because intake above BMD clearly exhibits pharmacological action. Nevertheless, due to uncertainties in dose-response modelling as well as the need for additional uncertainty factors to consider differences in sensitivity within the human population, a "borderline range" on the dose-response curve remains. "Pharmacological action" has proven to be not very well suited as binary decision criterion between foods and medicinal product. The European legislator should rethink the definition of medicinal products, as the current situation based on complicated case-by-case decisions on pharmacological action leads to an unregulated market flooded with potentially illegal food supplements. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. European Community (Radiological and Nuclear Medicine Installations) Regulations, 1998. Statutory Instrument S.I. No. 250 of 1998

    International Nuclear Information System (INIS)

    1998-01-01

    These regulations establish the criteria of acceptability to be met for radiological installations and nuclear medicine installations. The regulations implement the provisions of EC Directive 84/466 Euratom of 3 September 1984 laying down the basic measures for radiation protection of persons undergoing medical examinations or treatment and to provide protection for workers and the general public. (author)

  19. 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...

  20. Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries

    Directory of Open Access Journals (Sweden)

    Hartmann Markus

    2012-04-01

    Full Text Available Abstract Background Shifts in clinical trial application rates over time indicate if the attractiveness of a country or region for the conduct of clinical trials is growing or decreasing. The purpose of this observational study was to track changes in drug trial application patterns across several EU countries in order to analyze the medium-term impact of the EU Clinical Trials Directive 2001/20/EC on the conduct of drug trials. Methods Rates of Clinical Trial Applications (CTA for studies with medicinal products in those six countries in the EU, which authorize on average more than 500 trials per year, were analyzed. Publicly available figures on the number of annually submitted CTA, the distribution of trials per phase and the type of sponsorship were tracked; missing data were provided by national drug agencies. Results Since 2001, the number of CTA in Italy and Spain increased significantly (5.0 and 2.5% average annual growth. For Italy, the gain was driven by a strong increase of applications from academic trial sponsors; Spain's growth was due to a rise in trials run by commercial sponsors. The Netherlands, Germany, France and the UK saw a decline (1.9, 2.3, 3.0 and 5.3% average annual diminution; significant (P Conclusions The EU Clinical Trials Directive 2001/20/EC did not achieve the harmonization of clinical trial requirements across Europe. Rather, it resulted in the leveling of clinical trial activities caused by a continuing decrease in CTA rates in the Netherlands, Germany, France and the UK. Southern European countries, Italy and Spain, benefited to some extent from policy changes introduced by the Directive. In Italy's case, national funding measures helped to considerably promote the conduct of non-commercial trials. On the other hand, the EU Directive-driven transition from liberal policy environments, based on non-explicit trial approval through notifications, towards red-taped processes of trial authorization, contributed to

  1. 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

  2. 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

  3. [Storing succinylcholine in prehospital settings following the recommendations of the French National Agency for the safety of medicines].

    Science.gov (United States)

    Lefort, H; Mendibil, A; Margerin, S; Cuquel, A-C; Jost, D; Tazarourte, K; Domanski, L; Tourtier, J-P

    2014-06-01

    The French National Pharmaceuticals Agency (ANSM) has recommanded in July 2012 not to break the cold chain before using succinylcholine (Celocurine®). to understand the pre-clinical evolution of the conservation modes of this curare. Descriptive study before (year 2011) and after (year 2012). Online survey to French Samu/Smur. SMUR location, conservation method at clinical base, in the mobile unit (UMH) and at the patient. Principal decision criteria: evolution of the conservation modes before and after the recommendation (qualitatives variables compared with a Fisher test). Out of 101 SAMU/SMUR, 62 answered. Conservation modes of succinylcholine vials were significantly different (Pactive on UMH went from 31 % to 3.4 % with isotherms bags with ice when a fridge was not available. The destruction of capsules at current temperature in a 24-hour period increased: 22 % before, 47 % after (P=0.04). After recommendations from ANSM, conservation modes and destruction of succinylcholine in a prehospital environment were significantly impacted. Copyright © 2014 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.

  4. Medical imaging in personalised medicine: a white paper of the research committee of the European Society of Radiology (ESR).

    Science.gov (United States)

    2015-04-01

    The future of medicine lies in early diagnosis and individually tailored treatments, a concept that has been designated 'personalised medicine' (PM), which aims to deliver the right treatment to the right patient at the right time. Medical imaging has always been personalised and is fundamental to almost all aspects of PM. It is instrumental in solving clinical differential diagnoses. Imaging procedures are tailored to the clinical problem and patient characteristics. Screening for preclinical disease is done with imaging. Stratification based on imaging biomarkers can help identify individuals suited for preventive intervention. Treatment decisions are based on the in vivo visualisation of the location and extent of an abnormality, as well as the loco-regional physiological, biochemical and biological processes using structural and molecular imaging. Image-guided biopsy provides relevant tissue specimens for genetic/molecular characterisation. In addition, radiogenomics relate imaging biomarkers to these genetic and molecular features. Furthermore, imaging is essential to patient-tailored therapy planning, therapy monitoring and follow-up of disease, as well as targeting non-invasive or minimally invasive treatments, especially with the rise of theranostics. Radiologists need to be prepared for this new paradigm as it will mean changes in training, clinical practice and in research. Key Points • Medical imaging is a key component in personalised medicine • Personalised prevention will rely on image-based screening programmes • Anatomical, functional and molecular imaging biomarkers affect decisions on the type and intensity of treatment • Treatment response assessment with imaging will improve personalised treatment • Image-based invasive intervention integrates personalised diagnosis and personalised treatment.

  5. 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.

  6. [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.

  7. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

    Science.gov (United States)

    Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

    2018-02-01

    Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue

  8. Bulk processing of the Landsat MSS/TM/ETM+ archive of the European Space Agency: an insight into the level 1 MSS processing

    Science.gov (United States)

    Saunier, Sébastien; Northrop, Amy; Lavender, Samantha; Galli, Luca; Ferrara, Riccardo; Mica, Stefano; Biasutti, Roberto; Goryl, Philippe; Gascon, Ferran; Meloni, Marco

    2017-10-01

    Whilst recent years have witnessed the development and exploitation of operational Earth Observation (EO) satellite constellation data, the valorisation of historical archives has been a challenge. The European Space Agency (ESA) Landsat Multi Spectral Scanner (MSS) products cover Greenland, Iceland, Continental Europe and North Africa represent an archive of over 600,000 processed Level 1 (L1) scenes that will accompany around 1 million ESA Landsat Thematic Mapper (TM) and Enhanced Thematic Mapper Plus (ETM+) products already available. ESA began acquiring MSS data in 1975 and it is well known that this dataset can be degraded due to missing data and a loss in accuracy. For these reasons, the content of the product format has been reviewed and the ESA Landsat processing baseline significantly updated to ensure products are fit for user purposes. This paper presents the new MSS product format including the updated metadata parameters for error traceability, and the specification of the Quality Assurance Band (BQA) engineered to allow the best pixel selection and also the application of image restoration techniques. This paper also discusses major improvements applied to the radiometric and geometric processing. For the benefits of the community, ESA is now able to maximize the number of L1 MSS products that can potentially be generated from the raw Level 0 (L0) data and ensure the highest possible data quality is reached. Also, by improving product format, processing and adding a pixel based quality band, the MSS archive becomes interoperable with recently reprocessed Landsat data and that from live missions by way of assuring product quality on a pixel basis.

  9. Building an Open Data Portal for the European Space Agency Climate Change Initiative based on an Iterative Development Methodology and Linked Data Technologies

    Science.gov (United States)

    Kershaw, P.; Bennett, V. L.; Stephens, A.; Wilson, A.; Waterfall, A. M.; Petrie, R.; Iwi, A.; Donegan, S.; Juckes, M. N.; Parton, G.

    2016-12-01

    The Climate Change Initiative (CCI) programme was initiated by the European Space Agency (ESA) in 2009 to address the GCOS Essential Climate Variable (ECV) requirements to provide stable, long-term, satellite-based data products to characterise the climate system and its changes. CEDA, working as part of a project consortium, were awarded the contract to build the Open Data Portal, consisting collectively of a central archive and single point of access for dissemination of the data to the international user community. Reflecting climate and earth observation community requirements, the system needed to support a range of access services in use by this domain and specifically, to integrate into existing infrastructure in the form of the Earth System Grid Federation (ESGF). This range of requirements together with the heterogeneity of the ECV datasets presented significant challenges. However, the use of Linked Data technologies and an iterative approach to data model development and data publishing have been instrumental in meeting the objectives and building a cohesive system. The portal supports data discovery based on the OGC CSW specification and on ESGF's powerful faceted search. These services provide complementary content at different levels of granularity and it therefore became clear that a common data model was needed. Key terms are defined in vocabularies serialised in SKOS and OWL and are accessible from a central vocabulary server to provide a single authoritative source for applications consuming metadata content. Exploiting the vocabulary service therefore, it has been possible to develop an innovative solution tagging ISO 19115 records for the CSW with the equivalent vocabulary terms used for the ESGF faceted search system. In this way it has been possible to create a rich user interface for the portal combining search results from both search services and the ability to dynamically populate facet selection and context-based help information from the

  10. A new automatic synthetic aperture radar-based flood mapping application hosted on the European Space Agency's Grid Processing of Demand Fast Access to Imagery environment

    Science.gov (United States)

    Matgen, Patrick; Giustarini, Laura; Hostache, Renaud

    2012-10-01

    This paper introduces an automatic flood mapping application that is hosted on the Grid Processing on Demand (GPOD) Fast Access to Imagery (Faire) environment of the European Space Agency. The main objective of the online application is to deliver operationally flooded areas using both recent and historical acquisitions of SAR data. Having as a short-term target the flooding-related exploitation of data generated by the upcoming ESA SENTINEL-1 SAR mission, the flood mapping application consists of two building blocks: i) a set of query tools for selecting the "crisis image" and the optimal corresponding "reference image" from the G-POD archive and ii) an algorithm for extracting flooded areas via change detection using the previously selected "crisis image" and "reference image". Stakeholders in flood management and service providers are able to log onto the flood mapping application to get support for the retrieval, from the rolling archive, of the most appropriate reference image. Potential users will also be able to apply the implemented flood delineation algorithm. The latter combines histogram thresholding, region growing and change detection as an approach enabling the automatic, objective and reliable flood extent extraction from SAR images. Both algorithms are computationally efficient and operate with minimum data requirements. The case study of the high magnitude flooding event that occurred in July 2007 on the Severn River, UK, and that was observed with a moderateresolution SAR sensor as well as airborne photography highlights the performance of the proposed online application. The flood mapping application on G-POD can be used sporadically, i.e. whenever a major flood event occurs and there is a demand for SAR-based flood extent maps. In the long term, a potential extension of the application could consist in systematically extracting flooded areas from all SAR images acquired on a daily, weekly or monthly basis.

  11. 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.

  12. The Text of the Agreement of 6 September 1976 between The United Kingdom of Great Britain and Northern Ireland, The European Atomic Energy Community and the Agency in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1978-10-15

    The text of the Agreement, and of the Protocol which is an integral part thereof, between the United Kingdom of Great Britain and Northern Ireland, the European Atomic Energy Community and the Agency for the application of safeguards in the United Kingdom in connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members.

  13. 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

    International Nuclear Information System (INIS)

    1973-01-01

    The text of the Agreement, and of 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 (reproduced in document INFCIRC/140) is reproduced in this document for the information of all Members

  14. 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

    International Nuclear Information System (INIS)

    1973-01-01

    The text of the Agreement, and of 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 (reproduced in document INFCIRC/140) is reproduced in this document for the information of all Members [es

  15. The Text of the Agreement of 6 September 1976 between The United Kingdom of Great Britain and Northern Ireland, 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)

    1978-10-01

    The text of the Agreement, and of the Protocol which is an integral part thereof, between the United Kingdom of Great Britain and Northern Ireland, the European Atomic Energy Community and the Agency for the application of safeguards in the United Kingdom in connection with the Treaty on the Non-Proliferation of Nuclear Weapons is reproduced in this document for the information of all Members

  16. 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

    International Nuclear Information System (INIS)

    1977-01-01

    The Agreement of 5 April 1973, 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 111(1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons entered into force, pursuant to the first sentence of Article 25(a) thereof, on 21 February 1977 [es

  17. 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...

  18. Exercise in space: the European Space Agency approach to in-flight exercise countermeasures for long-duration missions on ISS.

    Science.gov (United States)

    Petersen, Nora; Jaekel, Patrick; Rosenberger, Andre; Weber, Tobias; Scott, Jonathan; Castrucci, Filippo; Lambrecht, Gunda; Ploutz-Snyder, Lori; Damann, Volker; Kozlovskaya, Inessa; Mester, Joachim

    2016-01-01

    To counteract microgravity (µG)-induced adaptation, European Space Agency (ESA) astronauts on long-duration missions (LDMs) to the International Space Station (ISS) perform a daily physical exercise countermeasure program. Since the first ESA crewmember completed an LDM in 2006, the ESA countermeasure program has strived to provide efficient protection against decreases in body mass, muscle strength, bone mass, and aerobic capacity within the operational constraints of the ISS environment and the changing availability of on-board exercise devices. The purpose of this paper is to provide a description of ESA's individualised approach to in-flight exercise countermeasures and an up-to-date picture of how exercise is used to counteract physiological changes resulting from µG-induced adaptation. Changes in the absolute workload for resistive exercise, treadmill running and cycle ergometry throughout ESA's eight LDMs are also presented, and aspects of pre-flight physical preparation and post-flight reconditioning outlined. With the introduction of the advanced resistive exercise device (ARED) in 2009, the relative contribution of resistance exercise to total in-flight exercise increased (33-46 %), whilst treadmill running (42-33 %) and cycle ergometry (26-20 %) decreased. All eight ESA crewmembers increased their in-flight absolute workload during their LDMs for resistance exercise and treadmill running (running speed and vertical loading through the harness), while cycle ergometer workload was unchanged across missions. Increased or unchanged absolute exercise workloads in-flight would appear contradictory to typical post-flight reductions in muscle mass and strength, and cardiovascular capacity following LDMs. However, increased absolute in-flight workloads are not directly linked to changes in exercise capacity as they likely also reflect the planned, conservative loading early in the mission to allow adaption to µG exercise, including personal comfort issues

  19. A new automatic SAR-based flood mapping application hosted on the European Space Agency's grid processing on demand fast access to imagery environment

    Science.gov (United States)

    Hostache, Renaud; Chini, Marco; Matgen, Patrick; Giustarini, Laura

    2013-04-01

    There is a clear need for developing innovative processing chains based on earth observation (EO) data to generate products supporting emergency response and flood management at a global scale. Here an automatic flood mapping application is introduced. The latter is currently hosted on the Grid Processing on Demand (G-POD) Fast Access to Imagery (Faire) environment of the European Space Agency. The main objective of the online application is to deliver flooded areas using both recent and historical acquisitions of SAR data in an operational framework. It is worth mentioning that the method can be applied to both medium and high resolution SAR images. The flood mapping application consists of two main blocks: 1) A set of query tools for selecting the "crisis image" and the optimal corresponding pre-flood "reference image" from the G-POD archive. 2) An algorithm for extracting flooded areas using the previously selected "crisis image" and "reference image". The proposed method is a hybrid methodology, which combines histogram thresholding, region growing and change detection as an approach enabling the automatic, objective and reliable flood extent extraction from SAR images. The method is based on the calibration of a statistical distribution of "open water" backscatter values inferred from SAR images of floods. Change detection with respect to a pre-flood reference image helps reducing over-detection of inundated areas. The algorithms are computationally efficient and operate with minimum data requirements, considering as input data a flood image and a reference image. Stakeholders in flood management and service providers are able to log onto the flood mapping application to get support for the retrieval, from the rolling archive, of the most appropriate pre-flood reference image. Potential users will also be able to apply the implemented flood delineation algorithm. Case studies of several recent high magnitude flooding events (e.g. July 2007 Severn River flood

  20. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

    Science.gov (United States)

    Boráň, Tomáš; Menezes-Ferreira, Margarida; Reischl, Ilona; Celis, Patrick; Ferry, Nicolas; Gänsbacher, Bernd; Krafft, Hartmut; Lipucci di Paola, Michele; Sladowski, Dariusz; Salmikangas, Paula

    2017-09-01

    The research and development of advanced therapy medicinal products (ATMPs) has been active in Europe and worldwide during recent years. Yet, the number of licensed products remains low. The main expected legal change in the near future in the European Union (EU) concerns the regulation on clinical trials (536/2014), which will come into force in 2018. With this new framework, a more harmonized and swift process for approval of clinical trials is anticipated, which is expected to support the entry of new innovations into the EU market. A survey on ATMPs in clinical trials during 2010-2015 in the EU was conducted in order to study the trends of ATMP development since the earlier survey published in 2012. According to the results, the number of clinical trials using ATMPs is slowly increasing in the EU. Yet, the focus is still in early development, and the projects are mainly carried out by small and medium-sized enterprises, academia, and hospitals. Oncology is the main area of clinical development. Yet, the balance between cell-based products and gene therapy medicinal products in this area may be changing in the future due to the new T-cell technologies. Many limitations and challenges are identified for ATMP development, requiring proportionate regulatory requirements. On the other hand, for such a novel field, the developers should be active in considering possible constraints and actively engage with authorities to look for solutions. This article provides up to-date information on forthcoming regulatory improvements and discusses the main challenges hampering the commercialization of ATMPs in the EU.

  1. 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

  2. Performance of cardiac cadmium-zinc-telluride gamma camera imaging in coronary artery disease: a review from the cardiovascular committee of the European Association of Nuclear Medicine (EANM)

    International Nuclear Information System (INIS)

    Agostini, Denis; Marie, Pierre-Yves; Ben-Haim, Simona; Rouzet, Francois; Songy, Bernard; Giordano, Alessandro; Gimelli, Alessia; Hyafil, Fabien; Sciagra, Roberto; Bucerius, Jan; Verberne, Hein J.; Slart, Riemer H.J.A.; Lindner, Oliver

    2016-01-01

    The trade-off between resolution and count sensitivity dominates the performance of standard gamma cameras and dictates the need for relatively high doses of radioactivity of the used radiopharmaceuticals in order to limit image acquisition duration. The introduction of cadmium-zinc-telluride (CZT)-based cameras may overcome some of the limitations against conventional gamma cameras. CZT cameras used for the evaluation of myocardial perfusion have been shown to have a higher count sensitivity compared to conventional single photon emission computed tomography (SPECT) techniques. CZT image quality is further improved by the development of a dedicated three-dimensional iterative reconstruction algorithm, based on maximum likelihood expectation maximization (MLEM), which corrects for the loss in spatial resolution due to line response function of the collimator. All these innovations significantly reduce imaging time and result in a lower patient's radiation exposure compared with standard SPECT. To guide current and possible future users of the CZT technique for myocardial perfusion imaging, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, has decided to examine the current literature regarding procedures and clinical data on CZT cameras. The committee hereby aims (1) to identify the main acquisitions protocols; (2) to evaluate the diagnostic and prognostic value of CZT derived myocardial perfusion, and finally (3) to determine the impact of CZT on radiation exposure. (orig.)

  3. Performance of cardiac cadmium-zinc-telluride gamma camera imaging in coronary artery disease: a review from the cardiovascular committee of the European Association of Nuclear Medicine (EANM)

    Energy Technology Data Exchange (ETDEWEB)

    Agostini, Denis [CHU Caen and Normandy University, Department of Nuclear Medicine, Caen (France); Normandy University, Caen (France); Marie, Pierre-Yves [University of Lorraine, Faculty of Medicine, Nancyclotep Experimental Imaging Platform, Nancy (France); University of Lorraine, Faculty of Medicine, CHU Nancy, Department of Nuclear Medicine, Nancy (France); University of Lorraine, Faculty of Medicine, Nancy (France); Ben-Haim, Simona [University College London, University College Hospital, Institute of Nuclear Medicine, London (United Kingdom); Chaim Sheba Medical Center, Department of Nuclear Medicine, Ramat Gan (Israel); Rouzet, Francois [University Hospital of Paris-Bichat, UMR 1148, Inserm et Paris Diderot-Paris 7 University Paris, Department of Nuclear Medicine, Paris (France); UMR 1148, Inserm and Paris Diderot-Paris 7 University Paris, Paris (France); Songy, Bernard [Centre Cardiologique du Nord, Saint-Denis (France); Giordano, Alessandro [Institute of Nuclear Medicine, Catholic University of Sacred Heart, Largo A. Gemelli, Department of Bioimages and Radiological Sciences, Rome (Italy); Gimelli, Alessia [Fondazione Toscana Gabriele Monasterio, Pisa (Italy); Hyafil, Fabien [Bichat University Hospital, Assistance Publique - Hopitaux de Paris, UMR 1148, Inserm and Paris Diderot-Paris 7 University, Department of Nuclear Medicine, Paris (France); Sciagra, Roberto [University of Florence, Nuclear Medicine Unit, Department of Experimental and Clinical Biomedical Sciences, Florence (Italy); Bucerius, Jan [Maastricht University Medical Center, Maastricht University Medical Center, Department of Nuclear Medicine, Maastricht (Netherlands); Maastricht University Medical Center, Cardiovascular Research Institute Maastricht (CARIM), Maastricht (Netherlands); University Hospital RWTH Aachen, Department of Nuclear Medicine, Aachen (Germany); Verberne, Hein J. [Academic Medical Center, Department of Nuclear Medicine, Amsterdam (Netherlands); Slart, Riemer H.J.A. [University Medical Center Groningen, Department of Nuclear Medicine and Molecular Imaging, Groningen (Netherlands); University of Twente, Faculty of Science and Technology, Department of Biomedical Photonic Imaging, Enschede (Netherlands); Lindner, Oliver [Institute of Radiology, Nuclear Medicine and Molecular Imaging, Heart and Diabetes Center NRW, Bad Oeynhausen (Germany); Collaboration: Cardiovascular Committee of the European Association of Nuclear Medicine (EANM)

    2016-12-15

    The trade-off between resolution and count sensitivity dominates the performance of standard gamma cameras and dictates the need for relatively high doses of radioactivity of the used radiopharmaceuticals in order to limit image acquisition duration. The introduction of cadmium-zinc-telluride (CZT)-based cameras may overcome some of the limitations against conventional gamma cameras. CZT cameras used for the evaluation of myocardial perfusion have been shown to have a higher count sensitivity compared to conventional single photon emission computed tomography (SPECT) techniques. CZT image quality is further improved by the development of a dedicated three-dimensional iterative reconstruction algorithm, based on maximum likelihood expectation maximization (MLEM), which corrects for the loss in spatial resolution due to line response function of the collimator. All these innovations significantly reduce imaging time and result in a lower patient's radiation exposure compared with standard SPECT. To guide current and possible future users of the CZT technique for myocardial perfusion imaging, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, has decided to examine the current literature regarding procedures and clinical data on CZT cameras. The committee hereby aims (1) to identify the main acquisitions protocols; (2) to evaluate the diagnostic and prognostic value of CZT derived myocardial perfusion, and finally (3) to determine the impact of CZT on radiation exposure. (orig.)

  4. Risk attitudes and personality traits predict perceptions of benefits and risks for medicinal products: a field study of European medical assessors.

    Science.gov (United States)

    Beyer, Andrea R; Fasolo, Barbara; de Graeff, P A; Hillege, H L

    2015-01-01

    Risk attitudes and personality traits are known predictors of decision making among laypersons, but very little is known of their influence among experts participating in organizational decision making. Seventy-five European medical assessors were assessed in a field study using the Domain Specific Risk Taking scale and the Big Five Inventory scale. Assessors rated the risks and benefits for a mock "clinical dossier" specific to their area of expertise, and ordinal regression models were used to assess the odds of risk attitude or personality traits in predicting either the benefit or the risk ratings. An increase in the "conscientiousness" score predicted an increase in the perception of the drug's benefit, and male assessors gave higher scores for the drug's benefit ratings than did female assessors. Extraverted assessors saw fewer risks, and assessors with a perceived neutral-averse or averse risk profile saw greater risks. Medical assessors perceive the benefits and risks of medicines via a complex interplay of the medical situation, their personality traits and even their gender. Further research in this area is needed to determine how these potential biases are managed within the regulatory setting. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  5. Clinical use of quantitative cardiac perfusion PET: rationale, modalities and possible indications. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM)

    International Nuclear Information System (INIS)

    Sciagra, Roberto; Passeri, Alessandro; Bucerius, Jan; Verberne, Hein J.; Slart, Riemer H.J.A.; Lindner, Oliver; Gimelli, Alessia; Hyafil, Fabien; Agostini, Denis; Uebleis, Christopher; Hacker, Marcus

    2016-01-01

    Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice. (orig.)

  6. 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...

  7. 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

  8. [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.

  9. Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries.

    Science.gov (United States)

    Morel, Thomas; Arickx, Francis; Befrits, Gustaf; Siviero, Paolo; van der Meijden, Caroline; Xoxi, Entela; Simoens, Steven

    2013-12-24

    National payers across Europe have been increasingly looking into innovative reimbursement approaches - called managed entry agreements (MEAs) - to balance the need to provide rapid access to potentially beneficial orphan medicinal products (OMPs) with the requirements to circumscribe uncertainty, obtain best value for money or to ensure affordability. This study aimed to identify, describe and classify MEAs applied to OMPs by national payers and to analyse their practice in Europe. To identify and describe MEAs, national health technology assessments and reimbursement decisions on OMPs across seven European countries were reviewed and their main characteristics extracted. To fill data gaps and validate the accuracy of the extraction, collaboration was sought from national payers. To classify MEAs, a bespoke taxonomy was implemented. Identified MEAs were analysed and compared by focusing on five key themes, namely by describing the MEAs in relation to: drug targets and therapeutic classes, geographical spread, type of MEA applied, declared rationale for setting-up of MEAs, and evolution over time. 42 MEAs for 26 OMPs, implemented between 2006 and 2012 and representing a variety of MEA designs, were identified. Italy was the country with the highest number of schemes (n=15), followed by the Netherlands (n=10), England and Wales (n=8), Sweden (n=5) and Belgium (n=4). No MEA was identified for France and Germany due to data unavailability. Antineoplastic agents were the primary targets of MEAs. 55% of the identified MEAs were performance-based risk-sharing arrangements; the other 45% were financial-based. Nine of these 26 OMPs were subject to MEAs in two or three different countries, resulting in 24 MEAs. 60% of identified MEAs focused on conditions whose prevalence is less than 1 per 10,000. This study confirmed that a variety of MEAs were increasingly used by European payers to manage aspects of uncertainty associated with the introduction of OMPs in the healthcare

  10. Barriers to access to opioid medicines for patients with opioid dependence: a review of legislation and regulations in eleven central and eastern European countries.

    Science.gov (United States)

    Vranken, Marjolein J M; Mantel-Teeuwisse, Aukje K; Jünger, Saskia; Radbruch, Lukas; Scholten, Willem; Lisman, John A; Subataite, Marija; Schutjens, Marie-Hélène D B

    2017-06-01

    Barriers linked to drug control systems are considered to contribute to inequitable access to controlled medicines, leaving millions of people in pain and suffering. Most studies focus on access to opioids for the treatment of severe (cancer) pain. This study aims to identify specific access barriers for patients with opioid dependence in legislation and regulations of 11 central and eastern European countries. This study builds on a previous analysis of legislation and regulations as part of the EU 7th Framework Access To Opioid Medication in Europe (ATOME) project. An in-depth analysis was undertaken to determine specific barriers for patients with opioid dependence in need of opioid analgesics or opioid agonist therapy (OAT). For each country, the number and nature of specific potential barriers for these patients were assessed according to eight categories: prescribing; dispensing; manufacturing; usage; trade and distribution; affordability; penalties; and other. An additional keyword search was conducted to minimize the omission of barriers. Barriers in an additional category, language, were recorded qualitatively. Countries included Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia and Turkey. Ten of the 11 countries (all except Estonia) showed specific potential barriers in their legislation and regulations. The total number of barriers varied from two (Slovenia) to 46 (Lithuania); the number of categories varied from one (Slovenia) to five (Lithuania). Most specific potential barriers were shown in the categories 'prescribing', 'usage' and 'other'. The total number in a single category varied from one to 18 (Lithuania, prescribing). Individual differences between countries in the same specific potential barrier were shown; for example, variation in minimum age criteria for admission to OAT ranging from 15 (Lithuania, in special cases) to 20 years (Greece). All countries had stigmatizing language in their legislation

  11. 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.

  12. Human papillomavirus vaccines, complex regional pain syndrome, postural orthostatic tachycardia syndrome, and autonomic dysfunction - a review of the regulatory evidence from the European Medicines Agency

    DEFF Research Database (Denmark)

    Jefferson, Tom; Jørgensen, Lars

    2017-01-01

    Recent concerns about a possible association between exposure of young women to human papillomavirus (HPV) vaccines and two "dysautonomic syndromes" (a collection of signs and symptoms thought to be caused by autoimmunity) - complex regional pain syndrome (CRPS) and postural orthostatic tachycardia...

  13. Communication dated 8 August 2006 from the Permanent Mission of Finland to the Agency concerning a Joint Action adopted by the Council of the European Union

    International Nuclear Information System (INIS)

    2006-01-01

    The Secretariat has received a Note Verbale dated 8 August 2006 from the Permanent Mission of Finland, attaching a new Joint Action adopted by the Council of the European Union on 12 June 2006 on support for IAEA activities in the areas of nuclear security and verification as part of the EU Strategy against Proliferation of Weapons of Mass Destruction. As requested in the Note Verbale, the Note and its attachment are herewith circulated as an Information Circular

  14. Nuclear Medicine Physics: A Handbook for Teachers and Students. Endorsed by: American Association of Physicists in Medicine (AAPM), Asia–Oceania Federation of Organizations for Medical Physics (AFOMP), Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM), European Federation of Organisations for Medical Physics (EFOMP), Federation of African Medical Physics Organisations (FAMPO), World Federation of Nuclear Medicine and Biology (WFNMB)

    Energy Technology Data Exchange (ETDEWEB)

    Bailey, D. L.; Humm, J. L.; Todd-Pokropek, A.; Aswegen, A. van [eds.

    2014-12-15

    This publication provides the basis for the education of medical physicists initiating their university studies in the field of nuclear medicine. The handbook includes 20 chapters and covers topics relevant to nuclear medicine physics, including basic physics for nuclear medicine, radionuclide production, imaging and non-imaging detectors, quantitative nuclear medicine, internal dosimetry in clinical practice and radionuclide therapy. It provides, in the form of a syllabus, a comprehensive overview of the basic medical physics knowledge required for the practice of medical physics in modern nuclear medicine.

  15. 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.

  16. 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.

  17. Traditional uses of medicinal plants reported by the indigenous communities and local herbal practitioners of Bajaur Agency, Federally Administrated Tribal Areas, Pakistan.

    Science.gov (United States)

    Aziz, Muhammad Abdul; Khan, Amir Hasan; Adnan, Muhammad; Izatullah, Izatullah

    2017-02-23

    In the study area, knowledge related to the traditional uses of medicinal plants is totally in the custody of elder community members and local herbalists. The younger generation is unaware of the traditional knowledge, however with only few exceptions. Therefore, this study was planned with objective to document the medicinal importance of plants, conserve this precious indigenous knowledge, and share it among other communities through published literature. Data was collected through semi-structured interviews from the community members and local herbalists. The reported plants were collected post interviews and later on pressed on herbarium vouchers for reference. Afterwards, the data was analyzed through Use value (UV) and Relative Frequency of Citation (RFC). In total, 79 medicinal plant species were used for the treatment of different ailments in the study region. Out of the total plant species, 28 species were not reported from any other mountainous communities across the country. In this study, the ethno-medicinal value of Opuntia littoralis (Engelm.) Cockerell and Viola indica W.Becker was reported for the first time, which have moderate confidential level in terms of their medicinal uses in the study area. Important medicinal plants of the region with high UV are Berberis lycium Royle (0.94), V. indica (0.90), Isodon rugosus (Wall. ex Benth.) Codd (0.88), Foeniculum vulgare Mill. (0.87), Peganum harmala L (0.86), Solanum virginianum L. (0.85), and Cassia fistula L. (0.79). Medicinal plants with higher RFC values are Calotropis procera (Aiton) Dryand. (0.86), Cannabis sativa L. (0.82), Mentha piperita L. (0.82), Mentha longifolia (L.) Huds. (0.76), Allium sativum L. (0.73), Coriandrum sativum L. (0.73), and F. vulgare (0.72). Traditional knowledge on folk medicines is directly linked to the local culture, faith and perception. This knowledge is gaining high threat of extinction because of its limitation to a small portion of the society in the region

  18. 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.

  19. [Ethical aspects of human embryonic stem cell use and commercial umbilical cord blood stem cell banking. Ethical reflections on the occasion of the regulation of the European Council and Parliament on advanced therapy medicinal products].

    Science.gov (United States)

    Virt, G

    2010-01-01

    The regulation of the European Council and Parliament on advanced therapy medicinal products also includes therapies with human embryonic stem cells. The use of these stem cells is controversially and heavily discussed. Contrary to the use of adult stem cells, medical and ethical problems concerning the use of human embryonic stem cells persists, because this use is based on the destruction of human life at the very beginning. The regulation foresees, therefore, subsidiarity within the European Member States. Although there are no ethical problems in principle with the use of stem cells from the umbilical cord blood, there are social ethical doubts with the banking of these stem cells for autologous use without any currently foreseeable medical advantage by commercial blood banks. Also in this case subsidiarity is valid.

  20. 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.

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. [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.

  12. Radiation protection dosimetry in medicine - Report of the working group n.9 of the European radiation dosimetry group (EURADOS) - coordinated network for radiation dosimetry (CONRAD - contract EC N) fp6-12684

    International Nuclear Information System (INIS)

    2009-01-01

    This report present the results achieved within the frame of the work the WP 7 (Radiation Protection Dosimetry of Medical Staff) of the coordination action CONRAD (Coordinated Network for Radiation Dosimetry) funded through the 6. EU Framework Program. This action was coordinated by EURADOS (European Radiation Dosimetry Group). EURADOS is an organization founded in 1981 to advance the scientific understanding and the technical development of the dosimetry of ionising radiation in the fields of radiation protection, radiobiology, radiation therapy and medical diagnosis by promoting collaboration between European laboratories. WP7 coordinates and promotes European research for the assessment of occupational exposures to staff in therapeutic and diagnostic radiology workplaces. Research is coordinated through sub-groups covering three specific areas: 1. Extremity dosimetry in nuclear medicine and interventional radiology: this sub-group coordinates investigations in the specific fields of the hospitals and studies of doses to different parts of the hands, arms, legs and feet; 2. Practice of double dosimetry: this sub-group reviews and evaluates the different methods and algorithms for the use of dosemeters placed above and below lead aprons in large exposure during interventional radiology procedures, especially to determine effective doses to cardiologists during cardiac catheterization; and 3. Use of electronic personal dosemeters in interventional radiology: this sub-group coordinates investigations in laboratories and hospitals, and intercomparisons with passive dosemeters with the aim to enable the formulation of standards. (authors)

  13. 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.

  14. 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

    NARCIS (Netherlands)

    Cornes, Michael P.; Church, Stephen; van Dongen-Lases, Edmée; Grankvist, Kjell; Guimarães, João T.; Ibarz, Mercedes; Kovalevskaya, Svetlana; Kristensen, Gunn Bb; Lippi, Giuseppe; Nybo, Mads; Sprongl, Ludek; Sumarac, Zorica; Simundic, Ana-Maria

    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

  15. Making doctor‐patient communication more effective from a patient’s perspective : A European mixed‐method study in general medicine settings

    NARCIS (Netherlands)

    Mazzi, Maria Angela

    2017-01-01

    The thesis investigated what in the eye of European citizens and primary care patients matters in doctor-patient communication. To include the public’s perspective in evaluating the communication quality of doctors is fundamental as patients often report quality problems in the area of communication

  16. Quantitative susceptibility of Streptococcus suis strains isolated from diseased pigs in seven European countries to antimicrobial agents licenced in veterinary medicine

    NARCIS (Netherlands)

    Wisselink, H.J.; Veldman, K.T.; Salmon, S.A.; Mevius, D.J.

    2006-01-01

    The susceptibility of Streptococcus suis strains (n = 384) isolated from diseased pigs in seven European countries to 10 antimicrobial agents was determined. For that purpose a microbroth dilution method was used according to CLSI recommendations. The following antimicrobial agents were tested:

  17. 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.

  18. 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

  19. 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

  20. 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

  1. Barriers to access to opioid medicines for patients with opioid dependence : a review of legislation and regulations in eleven central and eastern European countries

    NARCIS (Netherlands)

    Vranken, Marjolein J M; Mantel-Teeuwisse, Aukje K; Jünger, Saskia; Radbruch, Lukas; Scholten, Willem; Lisman, John A; Subataite, Marija; Schutjens, Marie-Hélène D B

    BACKGROUND AND AIMS: Barriers linked to drug control systems are considered to contribute to inequitable access to controlled medicines, leaving millions of people in pain and suffering. Most studies focus on access to opioids for the treatment of severe (cancer) pain. This study aims to identify

  2. 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 the Czech Republic

    International Nuclear Information System (INIS)

    2010-01-01

    The Agency received from the Czech Republic on 18 May 2009 and from the European Atomic Energy Community on 1 October 2009, the notifications required by Article 23(a) of the Agreement. Accordingly, the Agreement entered into force for the Czech Republic on 1 October 2009 [es

  3. 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

  4. 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

  5. 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 the Czech Republic

    International Nuclear Information System (INIS)

    2009-01-01

    The Agency received from the Czech Republic on 18 May 2009 and from the European Atomic Energy Community on 1 October 2009, the notifications required by Article 23(a) of the Agreement. Accordingly, the Agreement entered into force for the Czech Republic on 1 October 2009 [fr

  6. 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

  7. 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

  8. 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

  9. 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 the Czech Republic

    International Nuclear Information System (INIS)

    2009-01-01

    The Agency received from the Czech Republic on 18 May 2009 and from the European Atomic Energy Community on 1 October 2009, the notifications required by Article 23(a) of the Agreement. Accordingly, the Agreement entered into force for the Czech Republic on 1 October 2009

  10. Traditional use and safety of herbal medicines

    Directory of Open Access Journals (Sweden)

    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.

  11. 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)

  12. 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.

  13. 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

  14. Radiation protection dosimetry in medicine - Report of the working group n.9 of the European radiation dosimetry group (EURADOS) - coordinated network for radiation dosimetry (CONRAD - contract EC N) fp6-12684; Dosimetrie pour la radioprotection en milieu medical - rapport du groupe de travail n. 9 du European radiation dosimetry group (EURADOS) - coordinated netword for radiation dosimetry (CONRAD - contrat CE fp6-12684)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-07-01

    This report present the results achieved within the frame of the work the WP 7 (Radiation Protection Dosimetry of Medical Staff) of the coordination action CONRAD (Coordinated Network for Radiation Dosimetry) funded through the 6. EU Framework Program. This action was coordinated by EURADOS (European Radiation Dosimetry Group). EURADOS is an organization founded in 1981 to advance the scientific understanding and the technical development of the dosimetry of ionising radiation in the fields of radiation protection, radiobiology, radiation therapy and medical diagnosis by promoting collaboration between European laboratories. WP7 coordinates and promotes European research for the assessment of occupational exposures to staff in therapeutic and diagnostic radiology workplaces. Research is coordinated through sub-groups covering three specific areas: 1. Extremity dosimetry in nuclear medicine and interventional radiology: this sub-group coordinates investigations in the specific fields of the hospitals and studies of doses to different parts of the hands, arms, legs and feet; 2. Practice of double dosimetry: this sub-group reviews and evaluates the different methods and algorithms for the use of dosemeters placed above and below lead aprons in large exposure during interventional radiology procedures, especially to determine effective doses to cardiologists during cardiac catheterization; and 3. Use of electronic personal dosemeters in interventional radiology: this sub-group coordinates investigations in laboratories and hospitals, and intercomparisons with passive dosemeters with the aim to enable the formulation of standards. (authors)

  15. Nuclear medicine in the management of patients with heart failure: guidance from an expert panel of the International Atomic Energy Agency (IAEA).

    Science.gov (United States)

    Peix, Amalia; Mesquita, Claudio Tinoco; Paez, Diana; Pereira, Carlos Cunha; Felix, Renata; Gutierrez, Claudia; Jaimovich, Rodrigo; Ianni, Barbara Maria; Soares, Jose; Olaya, Pastor; Rodriguez, Ma Victoria; Flotats, Albert; Giubbini, Raffaele; Travin, Mark; Garcia, Ernest V

    2014-08-01

    Heart failure is increasing worldwide at epidemic proportions, resulting in considerable disability, mortality, and increase in healthcare costs. Gated myocardial perfusion single photon emission computed tomography or PET imaging is the most prominent imaging modality capable of providing information on global and regional ventricular function, the presence of intraventricular synchronism, myocardial perfusion, and viability on the same test. In addition, I-mIBG scintigraphy is the only imaging technique approved by various regulatory agencies able to provide information regarding the adrenergic function of the heart. Therefore, both myocardial perfusion and adrenergic imaging are useful tools in the workup and management of heart failure patients. This guide is intended to reinforce the information on the use of nuclear cardiology techniques for the assessment of heart failure and associated myocardial disease.

  16. 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

  17. [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.

  18. 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...

  19. Systematic review of cost-effectiveness of myocardial perfusion scintigraphy in patients with ischaemic heart disease: A report from the cardiovascular committee of the European Association of Nuclear Medicine. Endorsed by the European Association of Cardiovascular Imaging.

    Science.gov (United States)

    Trägårdh, Elin; Tan, Siok Swan; Bucerius, Jan; Gimelli, Alessia; Gaemperli, Oliver; Lindner, Oliver; Agostini, Denis; Übleis, Christopher; Sciagrà, Roberto; Slart, Riemer H; Underwood, S Richard; Hyafil, Fabien; Hacker, Marcus; Verberne, Hein J

    2017-05-01

    Coronary artery disease (CAD) is a major cause of death and disability. Several diagnostic tests, such as myocardial perfusion scintigraphy (MPS), are accurate for the detection of CAD, as well as having prognostic value for the prediction of cardiovascular events. Nevertheless, the diagnostic and prognostic value of these tests should be cost-effective and should lead to improved clinical outcome. We have reviewed the literature on the cost-effectiveness of MPS in different circumstances: (i) the diagnosis and management of CAD; (ii) comparison with exercise electrocardiography (ECG) and other imaging tests; (iii) as gatekeeper to invasive coronary angiography (ICA), (iv) the impact of appropriate use criteria; (v) acute chest pain, and (vi) screening of asymptomatic patients with type-2 diabetes. In total 57 reports were included. Although most non-invasive imaging tests are cost-effective compared with alternatives, the data conflict on which non-invasive strategy is the most cost-effective. Different definitions of cost-effectiveness further confound the subject. Computer simulations of clinical diagnosis and management are influenced by the assumptions made. For instance, diagnostic accuracy is often defined against an anatomical standard that is wrongly assumed to be perfect. Conflicting data arise most commonly from these incorrect or differing assumptions. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  20. Nuclear Medicine

    Science.gov (United States)

    ... Parents/Teachers Resource Links for Students Glossary Nuclear Medicine What is nuclear medicine? What are radioactive tracers? ... funded researchers advancing nuclear medicine? What is nuclear medicine? Nuclear medicine is a medical specialty that uses ...

  1. Teacher agency:

    DEFF Research Database (Denmark)

    Robinson, Sarah; Priestley, Mark; Biesta, Gert

    2015-01-01

    The concept of teacher agency has emerged in recent literature as an alternative means of understanding how teachers might enact practice and engage with policy (e.g. Lasky, 2005; Leander & Osbourne, 2008; Ketelaar et al., 2012; Priestley, Biesta & Robinson, 2013). But what is agency? Agency rema...

  2. 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...

  3. 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.

  4. Advertising Agencies

    DEFF Research Database (Denmark)

    Moeran, Brian

    2015-01-01

    Advertising agencies are the most significant organizations in the development of advertising and marketing worldwide. An advertising agency is an independent service company, composed of business, marketing and creative people, who develop, prepare, and place advertising in advertising media...... for their clients, the advertisers, who are in search of customers for their goods and services. Agencies thus mediate between three different but interlocking social groups: industry, media, and consumers. The history of advertising is largely the history of the advertising agencies that have served the needs....... This article is concerned with the origins, early developments, organization, compensation arrangements, and accounts of contemporary full-service advertising agencies....

  5. Protocol Additional to the agreement between the United Kingdom of Great Britain and Northern Ireland, the European Atomic Energy Community and the International Atomic Energy Agency for the application of safeguards in the United Kingdom of Great Britain and Northern Ireland in connection with the Treaty on the Non-Proliferation of Nuclear Weapons

    International Nuclear Information System (INIS)

    2005-01-01

    The text of the Protocol Additional to the Agreement between the United Kingdom of Great Britain and Northern Ireland, the European Atomic Energy Community and the International Atomic Energy Agency for the Application of Safeguards in the United Kingdom of Great Britain and Northern Ireland in Connection with the Treaty on the Non-Proliferation of Nuclear Weapons 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 17 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 the United Kingdom had met their respective internal requirements for entry into force

  6. European medicinal and edible plants associated with subacute and chronic toxicity part I: Plants with carcinogenic, teratogenic and endocrine-disrupting effects.

    Science.gov (United States)

    Kristanc, Luka; Kreft, Samo

    2016-06-01

    In recent decades, the use of herbal medicines and food products has been widely embraced in many developed countries. These products are generally highly accepted by consumers who often believe that "natural" equals "safe". This is, however, an oversimplification because several botanicals have been found to contain toxic compounds in concentrations harmful to human health. Acutely toxic plants are in most cases already recognised as dangerous as a result of their traditional use, but plants with subacute and chronic toxicity are difficult or even impossible to detect by traditional use or by clinical research studies. In this review, we systematically address major issues including the carcinogenicity, teratogenicity and endocrine-disrupting effects associated with the use of herbal preparations with a strong focus on plant species that either grow natively or are cultivated in Europe. The basic information regarding the molecular mechanisms of the individual subtypes of plant-induced non-acute toxicity is given, which is followed by a discussion of the pathophysiological and clinical characteristics. We describe the genotoxic and carcinogenic effects of alkenylbenzenes, pyrrolizidine alkaloids and bracken fern ptaquiloside, the teratogenicity issues regarding anthraquinone glycosides and specific alkaloids, and discuss the human health concerns regarding the phytoestrogens and licorice consumption in detail. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. The challenge of complex drug use: Associated use of codeine-containing medicines and new psychoactive substances in a European cross-sectional online population.

    Science.gov (United States)

    Kimergård, Andreas; Foley, Michelle; Davey, Zoe; Wadsworth, Elle; Drummond, Colin; Deluca, Paolo

    2017-05-01

    Misuse of codeine-containing medicines in combination with new psychoactive substances (NPS) is inadequately described. This study characterises codeine consumption amongst NPS users and non-NPS users to provide warning of health issues. Online survey conducted between July 2015 and March 2016. Out of 340 respondents, residing in a country in Europe and using codeine recently, 63.8% were female. Mean age: 34.9 years (SD = 12.4). Substance use included NPS (18.5%) and illicit controlled drugs (55.9%). Factors relating to codeine use found to significantly predict NPS use were consuming codeine extracted from combination tablets (OR = 16.79, 95% CI [8.67, 32.51]), obtaining codeine from friends, family, and acquaintances (OR = 3.98, 95% CI [1.82, 8.7]), use of illicit controlled drugs (OR = 34.99, 95% CI [8.39, 145.94]) and use of codeine to experience euphoria (OR = 6.41, 95% CI [3.42, 12.04]). Amongst NPS users, codeine is less likely to be used daily but more likely to be used for recreational purposes. Smaller populations engaging in high-risk use exist who take multiple drugs in high doses. Combinations of misused codeine and NPS highlight the need for policy to respond to a more complex drug situation. Copyright © 2017 John Wiley & Sons, Ltd.

  8. 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; Franklin, Nina Cherie; 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

    2015-08-01

    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. Copyright © 2015 Mayo Foundation for Medical Education and Research and the European Society of Cardiology. Published by Elsevier Inc. All rights reserved.

  9. European Union

    International Nuclear Information System (INIS)

    Schaller, K.

    1995-01-01

    Different instruments used by European Commission of the European Union for financial support radioactive waste management activities in the Russian Federation are outlined. Three particular programmes in the area are described

  10. 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.

  11. Report realized on the behalf of the Foreign Affairs Commission on the law project, adopted by the Senate, authorizing the added protocol ratification to the agreement between France, the European Atomic Energy Community and the International Atomic Energy Agency relative to the guaranties application in France

    International Nuclear Information System (INIS)

    2003-02-01

    This document presents the analyse of the law project, adopted by the Senate, authorizing the added protocol ratification to the agreement between France, the Atomic Energy European Community and the International Atomic Energy Agency relative to the guaranties application in France. It deals with the nuclear proliferation fight in France and the the program of enhancement of guaranties in the framework of the IAEA. (A.L.B.)

  12. 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

  13. Practice, science and governance in interaction: European effort for the system-wide implementation of the International Classification of Functioning, Disability and Health (ICF) in Physical and Rehabilitation Medicine.

    Science.gov (United States)

    Stucki, Gerold; Zampolini, Mauro; Juocevicius, Alvydas; Negrini, Stefano; Christodoulou, Nicolas

    2017-04-01

    Since its launch in 2001, relevant international, regional and national PRM bodies have aimed to implement the International Classification of Functioning, Disability and Health (ICF) in Physical and Rehabilitation Medicine (PRM), whereby contributing to the development of suitable practical tools. These tools are available for implementing the ICF in day-to-day clinical practice, standardized reporting of functioning outcomes in quality management and research, and guiding evidence-informed policy. Educational efforts have reinforced PRM physicians' and other rehabilitation professionals' ICF knowledge, and numerous implementation projects have explored how the ICF is applied in clinical practice, research and policy. Largely lacking though is the system-wide implementation of ICF in day-to-day practice across all rehabilitation services of national health systems. In Europe, system-wide implementation of ICF requires the interaction between practice, science and governance. Considering its mandate, the UEMS PRM Section and Board have decided to lead a European effort towards system-wide ICF implementation in PRM, rehabilitation and health care at large, in interaction with governments, non-governmental actors and the private sector, and aligned with ISPRM's collaboration plan with WHO. In this paper we present the current PRM internal and external policy agenda towards system-wide ICF implementation and the corresponding implementation action plan, while highlighting priority action steps - promotion of ICF-based standardized reporting in national quality management and assurance programs, development of unambiguous rehabilitation service descriptions using the International Classification System for Service Organization in Health-related Rehabilitation, development of Clinical Assessment Schedules, qualitative linkage and quantitative mapping of data to the ICF, and the cultural adaptation of the ICF Clinical Data Collection Tool in European languages.

  14. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H):Quinone Oxidoreductase Type 1 Induction.

    Science.gov (United States)

    Li, Shenghong; Qiu, Shengxiang; Yao, Ping; Sun, Handong; Fong, Harry H S; Zhang, Hongjie

    2013-01-01

    As part of our continuing efforts in the search for potential biologically active compounds from medicinal plants, we have isolated 18 compounds including two novel nitrogen containing diterpenes from extracts of the fruits of Vitex agnus-castus. These isolates, along with our previously obtained novel compound vitexlactam A (1), were evaluated for potential biological effects, including cancer chemoprevention. Chemically, the nitrogenous isolates were found to be two labdane diterpene alkaloids, each containing an α , β -unsaturated γ -lactam moiety. Structurally, they were elucidated to be 9 α -hydroxy-13(14)-labden-16,15-amide (2) and 6 β -acetoxy-9 α -hydroxy-13(14)-labden-15,16-amide (3), which were named vitexlactams B and C, respectively. The 15 known isolates were identified as vitexilactone (4), rotundifuran (5), 8-epi-manoyl oxide (6), vitetrifolin D (7), spathulenol (8), cis-dihydro-dehydro-diconiferylalcohol-9-O- β -D-glucoside (9), luteolin-7-O-glucoside (10), 5-hydroxy-3,6,7,4'-tetramethoxyflavone (11), casticin (12), artemetin (13), aucubin (14), agnuside (15), β -sitosterol (16), p-hydroxybenzoic acid (17), and p-hydroxybenzoic acid glucose ester (18). All compound structures were determined/identified on the basis of 1D and/or 2D NMR and mass spectrometry techniques. Compounds 6, 8, 9, and 18 were reported from a Vitex spieces for the first time. The cancer chemopreventive potentials of these isolates were evaluated for NADP(H):quinone oxidoreductase type 1 (QR1) induction activity. Compound 7 demonstrated promising QR1 induction effect, while the new compound vitexlactam (3) was only slightly active.

  15. Compounds from the Fruits of the Popular European Medicinal Plant Vitex agnus-castus in Chemoprevention via NADP(H:Quinone Oxidoreductase Type 1 Induction

    Directory of Open Access Journals (Sweden)

    Shenghong Li

    2013-01-01

    Full Text Available As part of our continuing efforts in the search for potential biologically active compounds from medicinal plants, we have isolated 18 compounds including two novel nitrogen containing diterpenes from extracts of the fruits of Vitex agnus-castus. These isolates, along with our previously obtained novel compound vitexlactam A (1, were evaluated for potential biological effects, including cancer chemoprevention. Chemically, the nitrogenous isolates were found to be two labdane diterpene alkaloids, each containing an α, β-unsaturated γ-lactam moiety. Structurally, they were elucidated to be 9α-hydroxy-13(14-labden-16,15-amide (2 and 6β-acetoxy-9α-hydroxy-13(14-labden-15,16-amide (3, which were named vitexlactams B and C, respectively. The 15 known isolates were identified as vitexilactone (4, rotundifuran (5, 8-epi-manoyl oxide (6, vitetrifolin D (7, spathulenol (8, cis-dihydro-dehydro-diconiferylalcohol-9-O-β-D-glucoside (9, luteolin-7-O-glucoside (10, 5-hydroxy-3,6,7,4′-tetramethoxyflavone (11, casticin (12, artemetin (13, aucubin (14, agnuside (15, β-sitosterol (16, p-hydroxybenzoic acid (17, and p-hydroxybenzoic acid glucose ester (18. All compound structures were determined/identified on the basis of 1D and/or 2D NMR and mass spectrometry techniques. Compounds 6, 8, 9, and 18 were reported from a Vitex spieces for the first time. The cancer chemopreventive potentials of these isolates were evaluated for NADP(H:quinone oxidoreductase type 1 (QR1 induction activity. Compound 7 demonstrated promising QR1 induction effect, while the new compound vitexlactam (3 was only slightly active.

  16. 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.

  17. 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

  18. 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

  19. Diplomatic agency

    DEFF Research Database (Denmark)

    Adler-Nissen, Rebecca

    2016-01-01

    diplomatic agency has been conceptualized in International Relations theory (English School, game theory, Foreign Policy Analysis, constructivism, practice theory, post-positivism) before presenting and exemplifying major and overlapping types of diplomatic agency, including communication, negotiation......Diplomatic agency is intriguing. On the one hand, diplomats are crucial to the management of day-to-day international relations and the negotiation of war and peace. On the other hand, most diplomatic action is highly constrained or invisible. This chapter provides an overview of the ways in which...... and advocacy. It analyzes how professionalization, legalization, personalization and popularization of diplomacy have shaped diplomatic agency including how international law, bureaucracy, public diplomacy and new information technologies have impacted the scope and content of diplomatic agency. Finally...

  20. 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.

  1. 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.

  2. European communion

    DEFF Research Database (Denmark)

    Manners, Ian James

    2013-01-01

    Political theory of European union, through an engagement between political concepts and theoretical understandings, provides a means of identifying the EU as a political object. It is argued that understanding the projects, processes and products of European union, based on ‘sharing’ or ‘communion......’, provides a better means of perceiving the EU as a political object rather than terms such as ‘integration’ or ‘co-operation’. The concept of ‘European communion’ is defined as the ‘subjective sharing of relationships’, understood as the extent to which individuals or groups believe themselves to be sharing...... relations (or not), and the consequences of these beliefs for European political projects, processes and products. By exploring European communion through an engagement with contemporary political theory, using very brief illustrations from the Treaty of Lisbon, the article also suggests that European...

  3. 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

  4. 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.

  5. Transformative Agency

    DEFF Research Database (Denmark)

    Majgaard, Klaus

    The purpose of this paper is to enhance the conceptual understanding of the mediatory relationship between paradoxes on an organizational and an individual level. It presents a concept of agency that comprises and mediates between a structural and individual pole. The constitution of this agency ...... is achieved through narrative activity that oscillates between the poles and transforms paradoxes through the configuration of plots and metaphors. Empirical cases are introduced in order to illustrate the implications of this understanding....

  6. European Institutions?

    NARCIS (Netherlands)

    Meacham, Darian

    2016-01-01

    The aim of this article is to sketch a phenomenological theory of political institutions and to apply it to some objections and questions raised by Pierre Manent about the project of the European Union and more specifically the question of “European Construction”, i.e. what is the aim of the

  7. European Whiteness?

    DEFF Research Database (Denmark)

    Blaagaard, Bolette

    2008-01-01

    Born out of the United States’ (U.S.) history of slavery and segregation and intertwined with gender studies and feminism, the field of critical whiteness studies does not fit easily into a European setting and the particular historical context that entails. In order for a field of European...

  8. 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.

  9. 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

  10. 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

  11. 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...

  12. The European Society of Regional Anaesthesia and Pain Therapy and the American Society of Regional Anesthesia and Pain Medicine Joint Committee Practice Advisory on Controversial Topics in Pediatric Regional Anesthesia.

    Science.gov (United States)

    Ivani, Giorgio; Suresh, Santhanam; Ecoffey, Claude; Bosenberg, Adrian; Lonnqvist, Per-Anne; Krane, Elliot; Veyckemans, Francis; Polaner, David M; Van de Velde, Marc; Neal, Joseph M

    2015-01-01

    Some topics in the clinical management of regional anesthesia in children remain controversial. To evaluate and come to a consensus regarding some of these topics, The European Society of Regional Anaesthesia and Pain Therapy (ESRA) and the American Society of Regional Anesthesia and Pain Medicine (ASRA) developed a joint committee practice advisory on pediatric regional anesthesia (PRA). Representatives from both ASRA and ESRA comprised the joint committee practice advisory on PRA. Evidence-based recommendations were based on a systematic search of the literature. In cases where no literature was available, expert opinion was elicited. Experts selected controversial topics in PRA. The performance of PRA under general anesthesia or deep sedation is associated with acceptable safety and should be viewed as the standard of care (Evidence B2 and Evidence B3). Because of the difficulty interpreting a negative test dose, the use of test dosing should remain discretionary (Evidence B4). The use of either air-loss of resistance or saline-loss of resistance techniques is supported by expert opinion, but the literature supporting one technique over the other is sparse and controversial; when used appropriately, each technique may be safely used in children. There are no current evidence-based data that the use of RA increases the risk for acute compartment syndrome or delays its diagnosis in children. High-level evidence is not yet available for the topics evaluated, and most recommendations are based on Evidence B studies. The ESRA/ASRA recommendations intend to provide guidance for the safe practice of regional anesthesia in children.

  13. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia.

    Science.gov (United States)

    Suresh, Santhanam; Ecoffey, Claude; Bosenberg, Adrian; Lonnqvist, Per-Anne; de Oliveira, Gildasio S; de Leon Casasola, Oscar; de Andrés, José; Ivani, Giorgio

    2018-02-01

    Dosage of local anesthetics (LAs) used for regional anesthesia in children is not well determined. In order to evaluate and come to a consensus regarding some of these controversial topics, The European Society of Regional Anaesthesia and Pain Therapy (ESRA) and the American Society of Regional Anesthesia and Pain Medicine (ASRA) developed a Joint Committee Practice Advisory on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Representatives from both ASRA and ESRA composed the joint committee practice advisory. Evidence-based recommendations were based on a systematic search of the literature. In cases where no literature was available, expert opinion was elicited. Spinal anesthesia with bupivacaine can be performed with a dose of 1 mg/kg for newborn and/or infant and a dose of 0.5 mg/kg in older children (>1 year of age). Tetracaine 0.5% is recommended for spinal anesthesia (dose, 0.07-0.13 mL/kg). Ultrasound-guided upper-extremity peripheral nerve blocks (eg, axillary, infraclavicular, interscalene, supraclavicular) in children can be performed successfully and safely using a recommended LA dose of bupivacaine or ropivacaine of 0.5 to 1.5 mg/kg. Dexmedetomidine can be used as an adjunct to prolong the duration of peripheral nerve blocks in children. High-level evidence is not yet available to guide dosage of LA used in regional blocks in children. The ASRA/ESRA recommendations intend to provide guidance in order to reduce the large variability of LA dosage currently observed in clinical practice.

  14. 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.

  15. Aerospace Medicine

    Science.gov (United States)

    Michaud, Vince

    2015-01-01

    NASA Aerospace Medicine overview - Aerospace Medicine is that specialty area of medicine concerned with the determination and maintenance of the health, safety, and performance of those who fly in the air or in space.

  16. 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.

  17. 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.

  18. 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 (OGGG) 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

    DEFF Research Database (Denmark)

    Singler, K.; Stuck, A. E.; Masud, T.

    2014-01-01

    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...... 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...

  19. European veterinary specialists denounce alternative medicine

    NARCIS (Netherlands)

    Horzinek, M.C.; Venker-van Haagen, Anjop

    On November 19, the Federation of Veterinarians in Europe (FVE) issued a policy statement urging its 200,000 members "to work only on the basis of scientifically proven and evidence-based methods and to stay away from non-evidence-based methods." The Swedish Veterinary Association banned its members

  20. Ear Acupuncture in European Traditional Medicine

    Directory of Open Access Journals (Sweden)

    Luigi Gori

    2007-01-01

    Full Text Available Auricular acupuncture is a diagnostic and treatment system based on normalizing the body's dysfunction through stimulation of definite points on the ear. Rudimentary forms of acupuncture which probably arose during the Stone Age have survived in many parts of the world right down to present day. It was used in the ancient Egypt, Rome, Greece and all the Mediterranean area. It is a microacupuncture technique similar to reflexology, and was first described in France in 1950 by Paul Nogier who is considered the Father of modern ear acupuncture. It was speculated that the technique works because groups of pluripotent cells contain information from the whole organism and create regional organization centers representing different parts of the body. Nevertheless stimulation of a reflex point in the ear seems relieve symptoms of distant pathologies. Modern research is confirming the efficacy of ear acupuncture for analgesia and anxiety related disease, while tobacco dependence and other substance abuse still need confirmation. Actually main methodological problems with auricular acupuncture are that exist too many maps with little agreement regarding point location in the ear, and that the correspondence or reflex systems does not correlated with modern knowledge of anatomy and physiology.

  1. Agency Theory

    DEFF Research Database (Denmark)

    Linder, Stefan; Foss, Nicolai Juul

    Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting and informational conditions, the theory addresses problems of ex...... ante (“hidden characteristics”) as well as ex post information asymmetry (“hidden action”), and examines conditions under which various kinds of incentive instruments and monitoring arrangements can be deployed to minimize the welfare loss. Its clear predictions and broad applicability have allowed...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism....

  2. Agency Theory

    DEFF Research Database (Denmark)

    Linder, Stefan; Foss, Nicolai Juul

    2015-01-01

    Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting, and informational conditions, the theory addresses problems of ex...... ante (‘hidden characteristics’) as well as ex post information asymmetry (‘hidden action’), and examines conditions under which various kinds of incentive instruments and monitoring arrangements can be deployed to minimize the welfare loss. Its clear predictions and broad applicability have allowed...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism....

  3. Selective Europeanization

    DEFF Research Database (Denmark)

    Hoch Jovanovic, Tamara; Lynggaard, Kennet

    2014-01-01

    and rules. The article examines the reasons for both resistance and selectiveness to Europeanization of the Danish minority policy through a “path dependency” perspective accentuating decision makers’ reluctance to deviate from existing institutional commitments, even in subsequently significantly altered...... political contexts at the European level. We further show how the “translation” of international norms to a domestic context has worked to reinforce the original institutional setup, dating back to the mid-1950s. The translation of European-level minority policy developed in the 1990s and 2000s works most...

  4. 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)

  5. Agency doctorates

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1970-07-01

    Mr. Wen-chuan Li of China has become the first student to obtain a doctor's degree as a result of research work carried out in the Agency. Mr. Li, who is 33, graduated as a Bachelor of Agriculture at Taiwan Provincial Chung-hsing University in 1960 and in 1966 was granted a fellowship to study mutations in plant breeding at the Agency's Seibersdorf Laboratory near Vienna, under the direction of Dr. Knut Mikaelsen, a professor of the University of Bergen. The Hochschule fur Bodenkultur of Vienna accepted the research as being suitable for a thesis and have now granted the degree of Doctor of Agriculture. The subject of the thesis was modifying factors influencing the mutagenic effects of alkylating agents as compared with ionizing radiations in barley. Alkylating agents are involved in the use of chemicals as a means of changing the characteristics of seeds to bring about changes aimed at improving the quality of crops. Mr. Li's work is regarded as a significant contribution to the understanding of the mechanics by which mutations are induced, to the efficient use of chemicals and ionizing radiations in practical applications, and to the efforts of the Agency in collaboration with the Food and Agriculture Organization to benefit food supplies. Mr. Li has now completed his fellowship with the Agency and has been appointed an Assistant Professor in Plant Breeding at Taiwan Provincial Chung-hsing University. The photograph, taken in the plastic hot house at Seibersdorf, shows him studying rice plants grown from seeds subjected to irradiation. Another noteworthy achievement is that of Mr. Karl-Franz Lacina, a security guard at the Agency's headquarters. At the age of 50 he has been accorded the degree of Doctor of Philosophy at Vienna University, the result of six years' work in his leisure time. The major subject was Arabic, with French and philosophy as supporting subject. (author)

  6. Agency doctorates

    International Nuclear Information System (INIS)

    1970-01-01

    Mr. Wen-chuan Li of China has become the first student to obtain a doctor's degree as a result of research work carried out in the Agency. Mr. Li, who is 33, graduated as a Bachelor of Agriculture at Taiwan Provincial Chung-hsing University in 1960 and in 1966 was granted a fellowship to study mutations in plant breeding at the Agency's Seibersdorf Laboratory near Vienna, under the direction of Dr. Knut Mikaelsen, a professor of the University of Bergen. The Hochschule fur Bodenkultur of Vienna accepted the research as being suitable for a thesis and have now granted the degree of Doctor of Agriculture. The subject of the thesis was modifying factors influencing the mutagenic effects of alkylating agents as compared with ionizing radiations in barley. Alkylating agents are involved in the use of chemicals as a means of changing the characteristics of seeds to bring about changes aimed at improving the quality of crops. Mr. Li's work is regarded as a significant contribution to the understanding of the mechanics by which mutations are induced, to the efficient use of chemicals and ionizing radiations in practical applications, and to the efforts of the Agency in collaboration with the Food and Agriculture Organization to benefit food supplies. Mr. Li has now completed his fellowship with the Agency and has been appointed an Assistant Professor in Plant Breeding at Taiwan Provincial Chung-hsing University. The photograph, taken in the plastic hot house at Seibersdorf, shows him studying rice plants grown from seeds subjected to irradiation. Another noteworthy achievement is that of Mr. Karl-Franz Lacina, a security guard at the Agency's headquarters. At the age of 50 he has been accorded the degree of Doctor of Philosophy at Vienna University, the result of six years' work in his leisure time. The major subject was Arabic, with French and philosophy as supporting subject. (author)

  7. European Security

    DEFF Research Database (Denmark)

    Møller, Bjørn

    Theoretical chapters on "Security", "Organisations" and "Regions," Historical Chapters on "Europe and Its Distinguishing Features" and on "The United Nations," "NATO," "The CSCE/OSCE and the Council of Europe" and "The European Union"......Theoretical chapters on "Security", "Organisations" and "Regions," Historical Chapters on "Europe and Its Distinguishing Features" and on "The United Nations," "NATO," "The CSCE/OSCE and the Council of Europe" and "The European Union"...

  8. 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

  9. 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.

  10. Building Capacity for Complementary and Integrative Medicine Through a Large, Cross-Agency, Acupuncture Training Program: Lessons Learned from a Military Health System and Veterans Health Administration Joint Initiative Project.

    Science.gov (United States)

    Niemtzow, Richard; Baxter, John; Gallagher, Rollin M; Pock, Arnyce; Calabria, Kathryn; Drake, David; Galloway, Kevin; Walter, Joan; Petri, Richard; Piazza, Thomas; Burns, Stephen; Hofmann, Lew; Biery, John; Buckenmaier, Chester

    2018-03-26

    Complementary and integrative medicine (CIM) use in the USA continues to expand, including within the Military Health System (MHS) and Veterans Health Administration (VHA). To mitigate the opioid crisis and provide additional non-pharmacological pain management options, a large cross-agency collaborative project sought to develop and implement a systems-wide curriculum, entitled Acupuncture Training Across Clinical Settings (ATACS). ATACS curriculum content and structure were created and refined over the course of the project in response to consultations with Subject Matter Experts and provider feedback. Course content was developed to be applicable to the MHS and VHA environments and training was open to many types of providers. Training included a 4-hr didactic and "hands on" clinical training program focused on a single auricular acupuncture protocol, Battlefield Acupuncture. Trainee learning and skills proficiency were evaluated by trainer-observation and written examination. Immediately following training, providers completed an evaluation survey on their ATACS experience. One month later, they were asked to complete another survey regarding their auricular acupuncture use and barriers to use. The present evaluation describes the ATACS curriculum, faculty and trainee characteristics, as well as trainee and program developer perspectives. Over the course of a 19-mo period, 2,712 providers completed the in-person, 4-hr didactic and hands-on clinical training session. Due to the increasing requests for training, additional ATACS faculty were trained. Overall, 113 providers were approved to be training faculty. Responses from the trainee surveys indicated high satisfaction with the ATACS training program and illuminated several challenges to using auricular acupuncture with patients. The most common reported barrier to using auricular acupuncture was the lack of obtaining privileges to administer auricular acupuncture within clinical practice. The ATACS program

  11. European Community.

    Science.gov (United States)

    1987-05-01

    The European Community was established in 1951 to reconcile France and Germany after World War II and to make possible the eventual federation of Europe. By 1986, there were 12 member countries: France, Italy, Belgium, the Federal Republic of Germany, Luxembourg, the Netherlands, Denmark, Ireland, the United Kingdom, Greece, Spain, and Portugal. Principal areas of concern are internal and external trade, agriculture, monetary coordination, fisheries, common industrial and commercial policies, assistance, science and research, and common social and regional policies. The European Community has a budget of US$34.035 billion/year, funded by customs duties and 1.4% of each member's value-added tax. The treaties establishing the European Community call for members to form a common market, a common customs tariff, and common agricultural, transport, economic, and nuclear policies. Major European Community institutions include the Commission, Council of Ministers, European Parliament, Court of Justice, and Economic and Social Committee. The Community is the world's largest trading unit, accounting for 15% of world trade. The 2 main goals of the Community's industrial policy are to create an open internal market and to promote technological innovation in order to improve international competitiveness. The European Community aims to contribute to the economic and social development of Third World countries as well.

  12. Nuclear medicine

    International Nuclear Information System (INIS)

    Lentle, B.C.

    1986-01-01

    Several growth areas for nuclear medicine were defined. Among them were: cardiac nuclear medicine, neuro-psychiatric nuclear medicine, and cancer diagnosis through direct tumor imaging. A powerful new tool, Positron Emission Tomography (PET) was lauded as the impetus for new developments in nuclear medicine. The political environment (funding, degree of autonomy) was discussed, as were the economic and scientific environments

  13. 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.

  14. 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.

  15. Heart failure - medicines

    Science.gov (United States)

    CHF - medicines; Congestive heart failure - medicines; Cardiomyopathy - medicines; HF - medicines ... You will need to take most of your heart failure medicines every day. Some medicines are taken ...

  16. Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder.

    Science.gov (United States)

    Agyemang, Elaine; Bailey, Lorna; Talbot, John

    2017-01-01

    Additional risk minimisation measures (aRMMs) for medicinal products are necessary to address specific important safety issues which may not be practically achieved through routine risk management measures alone. The implementation and determination of effectiveness for aRMMs can be a challenge as it involves multiple stakeholders. It is therefore important to have concise objectives to avoid undue burden on patients, healthcare professionals and the healthcare system. The aim of this study was to examine how aRMMs are implemented and how effectiveness is assessed in the European Union (EU) using practical examples from Roche Products Limited in the United Kingdom (UK) (referred to as the 'Company'). Three centrally authorised products were selected from the Company's portfolio, each of which had aRMMs to address important safety concerns; specifically, teratogenicity, medication error and infections. The implementation of EU aRMMs, effectiveness checks and specific UK activities were analysed. Hard copy folders and electronic sites for Company aRMMs were used to assess process indicators. Periodic benefit-risk evaluation reports for specified time intervals and the Company safety database was used in checking safety outcomes for the selected products. For each product, the effectiveness of aRMMs was analysed based on specific process indicators and the subsequent safety outcomes. Literature searches were performed on scientific databases for the purposes of the broader study. The main process indicators in measuring effectiveness of Company aRMMs were distribution metrics for educational materials, assessment of awareness and clinical actions among healthcare professionals (HCPs). Case reports of pregnancy, medication errors and progressive multifocal leukoencephalopathy (PML) were the outcome indicators for Erivedge ® ▼, Kadcyla ® ▼ and MabThera ® (the latter specifically in autoimmune indications: rheumatoid arthritis, granulomatosis with polyangiitis and

  17. Report realized on the behalf of the Foreign Affairs Commission on the law project, adopted by the Senate, authorizing the added protocol ratification to the agreement between France, the European Atomic Energy Community and the International Atomic Energy Agency relative to the guaranties application in France; Rapport fait au nom de la Commission des Affaires Etrangeres sur le projet de Loi, adopte par le Senat, autorisant la ratification du protocole additionnel a l'accord entre la France, la Communaute europeenne de l'energie atomique et l'Agence internationale de l'energie atomique relatif a l'application de garanties en France

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-02-01

    This document presents the analyse of the law project, adopted by the Senate, authorizing the added protocol ratification to the agreement between France, the Atomic Energy European Community and the International Atomic Energy Agency relative to the guaranties application in France. It deals with the nuclear proliferation fight in France and the the program of enhancement of guaranties in the framework of the IAEA. (A.L.B.)

  18. European visit

    CERN Multimedia

    2006-01-01

    The European Commissioner for Science and Research, Janez Potočnik, (on the right) visited the CMS assembly hall accompanied by Jim Virdee, Deputy Spokesman of CMS (on the left), and Robert Aymar, Director-General of CERN. The European Commissioner for Science and Research, Janez Potočnik, visited CERN on Tuesday 31 January. He was welcomed by the Director-General, Robert Aymar, who described the missions and current activities of CERN to him, in particular the realisation of the LHC with its three components: accelerator, detectors, storage and processing of data. The European Commissioner then visited the CMS assembly hall, then the hall for testing the LHC magnets and the ATLAS cavern. During this first visit since his appointment at the end of 2004, Janez Potočnik appeared very interested by the operation of CERN, an example of successful scientific co-operation on a European scale. The many projects (30 on average) that CERN and the European Commission carry out jointly for the benefit of res...

  19. 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/.

  20. 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/.

  1. European hadrons

    International Nuclear Information System (INIS)

    Anon.

    1986-01-01

    The European Hadron Facility (EHF) is a project for particle and nuclear physics in the 1990s which would consist of a fast cycling high intensity proton synchrotron of about 30 GeV primary energy and providing a varied spectrum of intense high quality secondary beams (polarized protons, pions, muons, kaons, antiprotons, neutrinos). The physics case of this project has been studied over the last two years by a European group of particle and nuclear physicists (EHF Study Group), whilst the conceptual design for the accelerator complex was worked out (and is still being worked on) by an international group of machine experts (EHF Design Study Group). Both aspects have been discussed in recent years in a series of working parties, topical seminars, and workshops held in Freiburg, Trieste, Heidelberg, Karlsruhe, Les Rasses and Villigen. This long series of meetings culminated in the International Conference on a European Hadron Facility held in Mainz from 10-14 March

  2. 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.

  3. European Cinema

    NARCIS (Netherlands)

    Elsaesser, Thomas

    2005-01-01

    In the face of renewed competition from Hollywood since the early 1980s and the challenges posed to Europe's national cinemas by the fall of the Wall in 1989, independent filmmaking in Europe has begun to re-invent itself. European Cinema: Face to Face with Hollywood re-assesses the different

  4. Diabetes Medicines

    Science.gov (United States)

    Diabetes means your blood glucose, or blood sugar, levels are too high. If you can't control your diabetes with wise food choices and physical activity, you may need diabetes medicines. The kind of medicine you take depends ...

  5. Herbal Medicine

    Science.gov (United States)

    ... used for its scent, flavor, or therapeutic properties. Herbal medicines are one type of dietary supplement. They are ... extracts, and fresh or dried plants. People use herbal medicines to try to maintain or improve their health. ...

  6. 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.

  7. 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...

  8. Folk Medicine

    Science.gov (United States)

    ... lead’s effects on health. How to tell if herbal medicines or folk medicines contain lead You only can ... as high as 90%. Ghasard, an Indian folk medicine, has also been found to contain lead. It is a brown powder used as a tonic. Ba-baw-san is a Chinese herbal remedy that contains lead. It is used to ...

  9. Agency doctorates

    International Nuclear Information System (INIS)

    1970-01-01

    Staff members of the Agency working at the Seibersdorf laboratory are continuing to achieve high academic distinction. Two more - both Austrian - have now been awarded the degree of Doctor of Agriculture. Joachim Kramer, who is 26, graduated from the Hochschule fur Bodenkultur in 1967 with the degree of Diplom-Ingenieur and then started work in the plant breeding and genetics section of the laboratory under the direction of Dr. Knut Mikaelsen. The results of the research work he carried out were accepted as the subject of a thesis for which he has now been granted his doctorate. The doctoral promotion took place on 30 June, at a ceremony attended by Dr. Andre Finkelstein, Deputy Director General for Research and Isotopes. The subject of Dr. Kramer's thesis was a comprehensive study of the mutagenic effects of fast neutrons and gamma rays, and the influence of various modifying factors such as water content, oxygen and metabolic state of seeds at the time of irradiation. This work has contributed significantly to the understanding of the mechanisms by which these two types of ionizing radiation produce mutations in seeds. The knowledge gained will be of great importance in the efficient use of ionizing radiation in practical plant breeding. Paul Wassermann, who is 33 years old, joined the Agency in 1965. He, too, graduated from the Hochschule fur Bodenkultur as Diplom-Ingenieur in agriculture, having graduated with honours previously from the agricultural secondary school at Raumberg, Austria, in 1958. Dr. Wassermann's own words may be used to explain how he came to gain his doctorate. 'In October, 1966, I completed my studies at the Hochschule,' he writes. 'I was employed at the Agency laboratories in Seibersdorf, working in the plant and soils group. Encouraged by the interesting research which was performed there, a thesis entitled 'the Fate of Nitrogen in Submerged Rice Soils' was started, which finally led to the doctor's degree in Agriculture in June this year

  10. 28 August 2013 - Director of Technical Quality Management Head of ESTEC Establishment European Space Agency F. Ongaro visiting the LHC tunnel at Point 1 with Technology Department Head F. Bordry and Technology Department J.-P. Tock; visiting the ATLAS experimental area with ATLAS Deputy Spokesperson T. Wengler and signing the guest book with CERN Director-General R. Heuer. Accompanied throughout by F. Bordry and V. Parma.

    CERN Multimedia

    Jean-Claude Gadmer

    2013-01-01

    28 August 2013 - Director of Technical Quality Management Head of ESTEC Establishment European Space Agency F. Ongaro visiting the LHC tunnel at Point 1 with Technology Department Head F. Bordry and Technology Department J.-P. Tock; visiting the ATLAS experimental area with ATLAS Deputy Spokesperson T. Wengler and signing the guest book with CERN Director-General R. Heuer. Accompanied throughout by F. Bordry and V. Parma.

  11. 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.

  12. Use Medicines Safely

    Science.gov (United States)

    ... Prescription Medicines 1 of 7 sections The Basics: Prescription Medicines There are different types of medicine. The 2 ... medicine are prescription and over-the-counter (OTC). Prescription medicines Prescription medicines are medicines you can get only ...

  13. 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

  14. Law project adopted by the Senate and authorizing the ratification of the additional protocol to the agreement between France, the European atomic energy community and the international atomic energy agency relative to the application of warranties in France

    International Nuclear Information System (INIS)

    2002-10-01

    This project of law concerns an additional protocol to the agreement of warranties signed on September 22, 1998 between France, the European atomic energy community and the IAEA. This agreement concerns the declaration of all information relative to the R and D activities linked with the fuel cycle and involving the cooperation with a foreign country non endowed with nuclear weapons. These information include the trade and processing of nuclear and non-nuclear materials and equipments devoted to nuclear reactors (pressure vessels, fuel loading/unloading systems, control rods, force and zirconium tubes, primary coolant pumps, deuterium and heavy water, nuclear-grade graphite), to fuel reprocessing plants, to isotope separation plants (gaseous diffusion, laser enrichment, plasma separation, electromagnetic enrichment), to heavy water and deuterium production plants, and to uranium conversion plants. (J.S.)

  15. Homo habitus: agency, structure and the transformation of tradition in the constitution of the TRB foraging-farming communities in the North European plain (ca 4500–2000 BC

    Directory of Open Access Journals (Sweden)

    Marek Zvelebil

    2005-12-01

    Full Text Available The current generally accepted view of the dispersal of farming into Europe is that farming groups in the eastern Mediterranean colonised selectively optimal farming areas. The role of contact between indigenous hunter-gatherers and incoming farmers was very important to the operation of this process. This general view of the spread of farming at a broad inter-regional scale gives us our understanding of the origins of the Neolithic but merits closer examination at the local and regional level, as increasingly it is becoming apparent that the causes and motivations may have differed. In this paper, Mesolithic to Neolithic communities with evidence of the transition from hunter-gatherer to farmer will be examined at a regional scale, in the central part of the north European plain, focussing on Kujavia. Additionally, the theory of structuration will be applied in order to elucidate the transition process at this level.

  16. Entre a Arbitragem Brasileira e a Arbitragem Europeia: Um estudo acerca da Agência Nacional de Telecomunicações (ANATEL e a Office of Comunications (OFCOM / Between the Brazilian and European Arbitration: A study of the National Telecommunications Agency (ANATEL and the Office of Communications (OFCOM

    Directory of Open Access Journals (Sweden)

    José Albenes Bezerra Júnior

    2017-04-01

    Full Text Available Purpose: The demand for arbitration as a dispute resolution is important due to the large volume of cases to be adjudicated at the Judiciary system and its lack of technical expertise to do so. The topic of alternative dispute resolution is clouded with debates of how far should it go before interfering in the core functions of the Judiciary. Thus, this paper seeks to support the use of arbitration in the Brazilian telecommunications sector, inspired by the experience of OFCOM. Methodology/Approach/Design: The paper starts with a historical analysis on the institute of the arbitrage followed by its connection with the regulatory phenomenon in Brazil and Europe. The study format follows a comparative approach by identifying the main characteristics of arbitration in both Brazilian and European telecommunications models. Results: One of the duties of the regulatory agencies is precisely the solution of conflicts between players in the sector at the administrative level. When analyzing the forms of dispute resolution in the European Union, a peculiar behavior can be highlighted. In major disputes that occur on the continent, it is more common to use arbitration than the judiciary. In fact, arbitration can be used by ANATEL as an important tool to ensure a broad, free and fair competition between providers of telecommunications services, as it dodges the slowness of the judiciary and the possibility of sham litigations, enabling the rapid adoption of a decision that often affects the rights of a great number of users of telecommunications services. The high prestige enjoyed by these methods of dispute resolution pays homage to their characteristic of being a neutral forum positioned far from a regulatory agency of a specific country and close to referees chosen by common agreement, or even connected to international institutions that provide the arbitration services in commercial disputes.

  17. 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

  18. Nuclear medicine

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, S M [Bhabha Atomic Research Centre, Bombay (India). Radiation Medicine Centre

    1967-01-01

    The article deals with the growth of nuclear medicine in India. Radiopharmaceuticals both in elemental form and radiolabelled compounds became commercially available in India in 1961. Objectives and educational efforts of the Radiation Medicine Centre setup in Bombay are mentioned. In vivo tests of nuclear medicine such as imaging procedures, dynamic studies, dilution studies, thyroid function studies, renal function studies, linear function studies, blood flow, and absorption studies are reported. Techniques of radioimmunoassay are also mentioned.

  19. Nuclear medicine

    International Nuclear Information System (INIS)

    Anon.

    1993-01-01

    The area of nuclear medicine, the development of artificially produced radioactive isotopes for medical applications, is relatively recent. Among the subjects covered in a lengthy discussion are the following: history of development; impact of nuclear medicine; understanding the most effective use of radioisotopes; most significant uses of nuclear medicine radioimmunoassays; description of equipment designed for use in the field of nuclear medicine (counters, scanning system, display systems, gamma camera); description of radioisotopes used and their purposes; quality control. Numerous historical photographs are included. 52 refs

  20. 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

  1. 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

  2. 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.

  3. European Utility Requirements: European nuclear energy

    International Nuclear Information System (INIS)

    Komsi, M.; Patrakka, E.

    1997-01-01

    The work procedure and the content of the European Utility Requirements (EUR) concerning the future LWRs is described in the article. European Utility Requirements, produced by utilities in a number of European countries, is a document specifying the details relating to engineered safety, operating performance, reliability and economics of the reactors to be built by manufacturers for the European market

  4. 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...

  5. 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.

  6. [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.

  7. Hair analysis in environmental medicine. Statement of the commission ''Human-Biomonitoring'' in the Federal Environmental Agency; Haaranalyse in der Umweltmedizin. Stellungnahme der Kommission ''Human-Biomonitoring'' des Umweltbundesamtes

    Energy Technology Data Exchange (ETDEWEB)

    Anon.

    2006-07-01

    In environmental medicine it is important to have easily accessible materials, that reflect medial long-term exposition. Against this background hair is used to monitor internal exposure to metals and metalloids in epidemiological and case studies. Although hair analysis is of limited value for the quantification of exposure to pollutants, it is still widely used. The commision has therefore throroughly evaluated the difficulties of hair analysis and gives recommendations. (uke)

  8. [On rhetorics and medicine].

    Science.gov (United States)

    Ohry, Avi; Gitay, Yehoshua

    2008-04-01

    The beginning of Rhetorics can be found in ancient Greece (Corax, Gorgias, Aristo). The science of the proper use of language in order to explain or convince, was very popular until the 17th century. Rhetorics had influenced all levels of intellectual European life, including medical teaching. and practice (Cabanis). Currently, rhetorics have become popular again in: the media, politics, academic and social life and medicine. Medical and allied health professions students, should learn how to speak correctly, how to implement ethical and behavioral essentials (Osler, Asher).

  9. Vulnerable Medicine

    Science.gov (United States)

    Bochner, Arthur P.

    2009-01-01

    In "Narrative Medicine: Honoring the Stories of Illness," Rita Charon paints an original and humane portrait of what it can mean to be a doctor, to live a life immersed in sickness and dedicated to wellness. Charon drops the veil, inviting readers to look at the secret, subjective, emotional face of medicine, a zone of self-censored feelings and…

  10. Medicinal claims

    NARCIS (Netherlands)

    Meulen, van der Bernd

    2017-01-01

    Under EU medicinal law, substances presented as having properties for treating or preventing disease are medicinal products by virtue of their presentation. EU food law prohibits attributing to any food the property of preventing, treating or curing a disease. However, if certain conditions are

  11. Ariane: NASA's European rival

    Science.gov (United States)

    The successful test launch of two three-quarter ton satellites in the European Space Agency's (ESA) Ariane rocket last June firmly placed ESA in competition with NASA for the lucrative and growing satellite launching market. Under the auspices of the private (but largely French-government financed) Arianespace company, ESA is already attracting customers to its three-stage rocket by offering low costs.According to recent reports [Nature, 292, pp. 785 and 788, 1981], Arianespace has been able to win several U.S. customers away from NASA, including Southern Pacific Communications, Western Union, RCA, Satellite Television Corporation, and GTE. Nature [292, 1981] magazine in an article entitled ‘More Trouble for the Hapless Shuttle’ suggests that it will be possible for Ariane to charge lower prices for a launch than NASA, even with the space shuttle.

  12. [Evolutionary medicine].

    Science.gov (United States)

    Wjst, M

    2013-12-01

    Evolutionary medicine allows new insights into long standing medical problems. Are we "really stoneagers on the fast lane"? This insight might have enormous consequences and will allow new answers that could never been provided by traditional anthropology. Only now this is made possible using data from molecular medicine and systems biology. Thereby evolutionary medicine takes a leap from a merely theoretical discipline to practical fields - reproductive, nutritional and preventive medicine, as well as microbiology, immunology and psychiatry. Evolutionary medicine is not another "just so story" but a serious candidate for the medical curriculum providing a universal understanding of health and disease based on our biological origin. © Georg Thieme Verlag KG Stuttgart · New York.

  13. 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; Texte de l'Accord entre la Belgique, le Danemark, la Republique Federale d' Allemagne, l'Irlande, l'Italie, le Luxembourg, les Pays-Bas, la Communaute Europeenne de l'En-Ergie Atomique et L'Agence En Application Du Traite Sur La Non-Proliferation Des Armes Nucleaires

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1973-09-14

    The text of the Agreement, and of 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 (reproduced in document INFCIRC/140) is reproduced in this document for the information of all Members [French] Le texte de l'Accord, ainsi que celui du Protocole qui y est joint, entre la Belgique, le Danemark, la Republique fdrale d'Allemae, l'Irlande, l'Italie, le Luxembourg, les Pays-Bas, la Communaute europenne de l'energie atomique et l'Agence condu en application des paragraphes 1 et 4 de l'article III du Traite sur la non proliferation des armes nucleaires sont reproduits dans le present document pour l'information de tous les Membres.

  14. Nuclear medicine

    International Nuclear Information System (INIS)

    Kand, Purushottam

    2012-01-01

    Nuclear medicine is a specialized area of radiology that uses very small amounts of radioactive materials to examine organ function and structure. Nuclear medicine is older than CT, ultrasound and MRI. It was first used in patients over 60-70 years ago. Today it is an established medical specialty and offers procedures that are essential in many medical specialities like nephrology, pediatrics, cardiology, psychiatry, endocrinology and oncology. Nuclear medicine refers to medicine (a pharmaceutical) that is attached to a small quantity of radioactive material (a radioisotope). This combination is called a radiopharmaceutical. There are many radiopharmaceuticals like DTPA, DMSA, HIDA, MIBI and MDP available to study different parts of the body like kidneys, heart and bones etc. Nuclear medicine uses radiation coming from inside a patient's body where as conventional radiology exposes patients to radiation from outside the body. Thus nuclear imaging study is a physiological imaging, whereas diagnostic radiology is anatomical imaging. It combines many different disciplines like chemistry, physics mathematics, computer technology, and medicine. It helps in diagnosis and to treat abnormalities very early in the progression of a disease. The information provides a quick and accurate diagnosis of wide range of conditions and diseases in a person of any age. These tests are painless and most scans expose patients to only minimal and safe amounts of radiation. The amount of radiation received from a nuclear medicine procedure is comparable to, or often many times less than, that of a diagnostic X-ray. Nuclear medicine provides an effective means of examining whether some tissues/organs are functioning properly. Therapy using nuclear medicine in an effective, safe and relatively inexpensive way of controlling and in some cases eliminating, conditions such as overactive thyroid, thyroid cancer and arthritis. Nuclear medicine imaging is unique because it provides doctors with

  15. 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...

  16. 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.

  17. [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.

  18. Radiation protection in medicine

    International Nuclear Information System (INIS)

    Vano, E.; Holmberg, O.; Perez, M. R.; Ortiz, P.

    2016-01-01

    Diagnostic, interventional and therapeutic used of ionizing radiation are beneficial for hundreds of millions of people each year by improving health care and saving lives. In March 2001, the first International Conference on the Radiological Protection of Patients was held in Malaga, Spain, which led to an international action plan for the radiation protection of patients. Ten years after establishing the international action plan, the International Conference on Radiation Protection in Medicine: Setting the Scene for the Next Decade was held in Bonn, Germany, in December 2012. the main outcome of this conference was the so called Bonn Call for Action that identifies then priority actions to enhance radiation protection in medicine for the next decade. The IAEA and WHO are currently working in close cooperation to foster and support the implementation of these ten priority actions in Member States, but their implementation requires collaboration of national governments, international agencies, researchers, educators, institutions and professional associations. (Author)

  19. Radiation protection in medicine

    Energy Technology Data Exchange (ETDEWEB)

    Vano, E.; Holmberg, O.; Perez, M. R.; Ortiz, P.

    2016-08-01

    Diagnostic, interventional and therapeutic used of ionizing radiation are beneficial for hundreds of millions of people each year by improving health care and saving lives. In March 2001, the first International Conference on the Radiological Protection of Patients was held in Malaga, Spain, which led to an international action plan for the radiation protection of patients. Ten years after establishing the international action plan, the International Conference on Radiation Protection in Medicine: Setting the Scene for the Next Decade was held in Bonn, Germany, in December 2012. the main outcome of this conference was the so called Bonn Call for Action that identifies then priority actions to enhance radiation protection in medicine for the next decade. The IAEA and WHO are currently working in close cooperation to foster and support the implementation of these ten priority actions in Member States, but their implementation requires collaboration of national governments, international agencies, researchers, educators, institutions and professional associations. (Author)

  20. Ayurvedic Medicine

    Science.gov (United States)

    ... to the biologic humors of the ancient Greek system. Using these concepts, Ayurvedic physicians prescribe individualized treatments, including compounds of herbs or proprietary ingredients, and diet, exercise, and lifestyle recommendations. The majority of India’s population uses Ayurvedic medicine ...

  1. COPD Medicine

    Science.gov (United States)

    ... Education & Training Home Treatment & Programs Medications COPD Medications COPD Medications Make an Appointment Ask a Question Refer ... control the symptoms of chronic obstructive pulmonary disease (COPD). Most people with COPD take long-acting medicine ...

  2. Nuclear medicine

    International Nuclear Information System (INIS)

    Blanquet, Paul; Blanc, Daniel.

    1976-01-01

    The applications of radioisotopes in medical diagnostics are briefly reviewed. Each organ system is considered and the Nuclear medicine procedures pertinent to that system are discussed. This includes, the principle of the test, the detector and the radiopharmaceutical used, the procedure followed and the clinical results obtained. The various types of radiation detectors presently employed in Nuclear Medicine are surveyed, including scanners, gamma cameras, positron cameras and procedures for obtaining tomographic presentation of radionuclide distributions [fr

  3. Nuclear medicine

    International Nuclear Information System (INIS)

    Chamberlain, M.J.

    1986-01-01

    Despite an aggressive, competitive diagnostic radiology department, the University Hospital, London, Ontario has seen a decline of 11% total (in vivo and in the laboratory) in the nuclear medicine workload between 1982 and 1985. The decline of in vivo work alone was 24%. This trend has already been noted in the U.S.. Nuclear medicine is no longer 'a large volume prosperous specialty of wide diagnostic application'

  4. Protocol Additional to the Agreement between the Republic of Austria, the Kingdom of Belgium, the Kingdom of Denmark, the Republic of Finland, the Federal Republic of Germany, the Hellenic Republic, Ireland, the Italian Republic, the Grand Duchy of Luxembourg, the Kingdom of The Netherlands, the Portuguese Republic, the Kingdom of Spain, the Kingdom of Sweden, the European Atomic Energy Community and the International Atomic Energy Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Bulgaria

    International Nuclear Information System (INIS)

    2009-01-01

    The Agency received from the Republic of Bulgaria on 15 September 2008 and from the European Atomic Energy Community on 1 May 2009, notification that their respective requirements had been met. Accordingly, the Additional Protocol came into force for Bulgaria on 1 May 2009 [es

  5. Protocol Additional to the Agreement between the Republic of Austria, the Kingdom of Belgium, the Kingdom of Denmark, the Republic of Finland, the Federal Republic of Germany, the Hellenic Republic, Ireland, the Italian Republic, the Grand Duchy of Luxembourg, the Kingdom of The Netherlands, the Portuguese Republic, the Kingdom of Spain, the Kingdom of Sweden, the European Atomic Energy Community and the International Atomic Energy Agency in implementation of Article III, (1) and (4) of 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, notification that their respective requirements had been met. Accordingly, the Additional Protocol came into force for Romania on 1 May 2010 [es

  6. Protocol Additional to the Agreement between the Republic of Austria, the Kingdom of Belgium, the Kingdom of Denmark, the Republic of Finland, the Federal Republic of Germany, the Hellenic Republic, Ireland, the Italian Republic, the Grand Duchy of Luxembourg, the Kingdom of The Netherlands, the Portuguese Republic, the Kingdom of Spain, the Kingdom of Sweden, the European Atomic Energy Community and the International Atomic Energy Agency in implementation of Article III, (1) and (4) of the Treaty on the Non-Proliferation of Nuclear Weapons. Accession of Bulgaria

    International Nuclear Information System (INIS)

    2009-01-01

    The Agency received from the Republic of Bulgaria on 15 September 2008 and from the European Atomic Energy Community on 1 May 2009, notification that their respective requirements had been met. Accordingly, the Additional Protocol came into force for Bulgaria on 1 May 2009 [fr

  7. 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.

  8. 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...

  9. 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...

  10. 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.

  11. [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.

  12. Recommendations for an update of the 2010 European regulatory guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis and reflections about related clinically relevant outcomes: expert consensus statement.

    Science.gov (United States)

    Reginster, J-Y; Reiter-Niesert, S; Bruyère, O; Berenbaum, F; Brandi, M-L; Branco, J; Devogelaer, J-P; Herrero-Beaumont, G; Kanis, J; Maggi, S; Maheu, E; Richette, P; Rizzoli, R; Cooper, C

    2015-12-01

    The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on clinical investigation of drugs used in the treatment of osteoarthritis (OA). Areas of potential attention were identified and the need for modifications, update or clarification was examined. Proposals were then developed based on literature reviews and through a consensus process. It was agreed that the current guideline overall still reflects the current knowledge in OA, although two possible modifications were identified. The first relates to the number and timing of measurements required as primary endpoints during clinical trials of symptom-relieving drugs, either drugs with rapid onset of action or slow acting drugs. The suggested modifications are intended to take into consideration the time related clinical need and expected time response to these drugs - i.e., a more early effect for the first category in addition to the maintenance of effect, a more continuous benefit over the long-term for the latter - in the timing of assessments. Secondly, values above which a benefit over placebo should be considered clinically relevant were considered. Based on literature reviews, the most consensual values were determined for primary endpoints of both symptom-relieving drugs (i.e., pain intensity on a visual analogue scale (VAS)) and disease-modifying drugs (i.e., radiographic joint-space narrowing). This working document might be considered by the European regulatory authorities in a future update of the guideline for the registration of drugs in OA. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. 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...

  14. 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...

  15. 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.

  16. 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...

  17. Travel medicine

    Science.gov (United States)

    Aw, Brian; Boraston, Suni; Botten, David; Cherniwchan, Darin; Fazal, Hyder; Kelton, Timothy; Libman, Michael; Saldanha, Colin; Scappatura, Philip; Stowe, Brian

    2014-01-01

    Abstract Objective To define the practice of travel medicine, provide the basics of a comprehensive pretravel consultation for international travelers, and assist in identifying patients who might require referral to travel medicine professionals. Sources of information Guidelines and recommendations on travel medicine and travel-related illnesses by national and international travel health authorities were reviewed. MEDLINE and EMBASE searches for related literature were also performed. Main message Travel medicine is a highly dynamic specialty that focuses on pretravel preventive care. A comprehensive risk assessment for each individual traveler is essential in order to accurately evaluate traveler-, itinerary-, and destination-specific risks, and to advise on the most appropriate risk management interventions to promote health and prevent adverse health outcomes during travel. Vaccinations might also be required and should be personalized according to the individual traveler’s immunization history, travel itinerary, and the amount of time available before departure. Conclusion A traveler’s health and safety depends on a practitioner’s level of expertise in providing pretravel counseling and vaccinations, if required. Those who advise travelers are encouraged to be aware of the extent of this responsibility and to refer all high-risk travelers to travel medicine professionals whenever possible. PMID:25500599

  18. Mesopotamian medicine.

    Science.gov (United States)

    Retief, F P; Cilliers, L

    2007-01-01

    Although the Mesopotamian civilisation is as old as that of Egypt and might even have predated it, we know much less about Mesopotamian medicine, mainly because the cuneiform source material is less well researched. Medical healers existed from the middle of the 3rd millennium. In line with the strong theocratic state culture, healers were closely integrated with the powerful priestly fraternity, and were essentially of three main kinds: barû (seers) who were experts in divination, âshipu (exorcists), and asû (healing priests) who tended directly to the sick. All illness was accepted as sent by gods, demons and other evil spirits, either as retribution for sins or as malevolent visitations. Treatment revolved around identification of the offending supernatural power, appeasement of the angry gods, for example by offering amulets or incantations, exorcism of evil spirits, as well as a measure of empirical therapy aimed against certain recognised symptom complexes. Medical practice was rigidly codified, starting with Hammurabi's Code in the 18th century BC and persisting to the late 1st millennium BC. Works like the so-called Diagnostic Handbook, the Assyrian Herbal and Prescription Texts describe the rationale of Mesopotamian medicine, based predominantly on supernatural concepts, although rudimentary traces of empirical medicine are discernible. There is evidence that Egyptian medicine might have been influenced by Mesopotamian practices, but Greek rational medicine as it evolved in the 5th/4th centuries BC almost certainly had no significant Mesopotamian roots.

  19. 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.

  20. Medicines by Design

    Science.gov (United States)

    ... Home > Science Education > Medicines By Design Medicines By Design Spotlight Nature's Medicine Cabinet A Medicine's Life Inside ... hunt for drugs of the future. Medicines By Design in PDF | E-PUB Tell Us What You ...

  1. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... Physician Resources Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses ... limitations of Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of ...

  2. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses small amounts ... Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of medical imaging ...

  3. General Nuclear Medicine

    Science.gov (United States)

    ... Resources Professions Site Index A-Z General Nuclear Medicine Nuclear medicine imaging uses small amounts of radioactive ... of General Nuclear Medicine? What is General Nuclear Medicine? Nuclear medicine is a branch of medical imaging ...

  4. Children's (Pediatric) Nuclear Medicine

    Science.gov (United States)

    ... Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses small amounts ... Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of medical imaging ...

  5. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... News Physician Resources Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging ... the limitations of Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch ...

  6. Children's (Pediatric) Nuclear Medicine

    Medline Plus

    Full Text Available ... Resources Professions Site Index A-Z Children's (Pediatric) Nuclear Medicine Children’s (pediatric) nuclear medicine imaging uses small ... of Children's Nuclear Medicine? What is Children's (Pediatric) Nuclear Medicine? Nuclear medicine is a branch of medical ...

  7. 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

  8. 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…

  9. 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...

  10. [Medicinal cannabis].

    Science.gov (United States)

    Van der Meersch, H; Verschuere, A P; Bottriaux, F

    2006-01-01

    Pharmaceutical grade cannabis is available to Dutch patients from public pharmacies in the Netherlands. The first part of this paper reviews the pharmaceutical and pharmacological properties of medicinal cannabis. Detailed information about its composition and quality, potential applications, methods of administration, adverse reactions, drug interactions and safety during pregnancy or breastfeeding are given. The second part deals with the legal aspects of dispensing medicinal cannabis through pharmacies in view of the Belgian and Dutch legislation. The last part discusses the present Belgian regulation about the possession of cannabis.

  11. Nuclear medicine

    International Nuclear Information System (INIS)

    Reichelt, H.G.

    1980-01-01

    Nuclear medicine as a complex diagnostical method is used mainly to detect functional organic disorders, to locate disorders and for radioimmunologic assays (RIA) in vitro. In surgery, its indication range comprises the thyroid (in vivo and in vitro), liver and bile ducts, skeletal and joint diseases, disorders of the cerebro-spinal liquor system and the urologic disorders. In the early detection of tumors, the search for metastases and tumor after-care, scintiscanning and the tumor marcher method (CEA) can be of great practical advantage, but the value of myocardial sciritiscanning in cardiac respectively coronary disorders is restricted. The paper is also concerned with the radiation doses in nuclear medicine. (orig.) [de

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. Mountain medicin

    DEFF Research Database (Denmark)

    Bay, Bjørn; Hjuler, Kasper Fjellhaugen

    2016-01-01

    medicine. The first part covered high-altitude physiology and medical aspects of objective alpine dangers and the increased exposure to ultraviolet radiation. This part covers altitude sickness, fluid balance, nutrition, and precautions for patients with pre-existing medical conditions, pregnant women...

  17. Personalized medicine

    DEFF Research Database (Denmark)

    Bendtzen, Klaus

    2013-01-01

    engineered anti-TNF-alpha antibody constructs now constitute one of the heaviest medicinal expenditures in many countries. All currently used TNF antagonists may dramatically lower disease activity and, in some patients, induce remission. Unfortunately, however, not all patients respond favorably, and safety...

  18. Predictive medicine

    NARCIS (Netherlands)

    Boenink, Marianne; ten Have, Henk

    2015-01-01

    In the last part of the twentieth century, predictive medicine has gained currency as an important ideal in biomedical research and health care. Research in the genetic and molecular basis of disease suggested that the insights gained might be used to develop tests that predict the future health

  19. Medicinal Mushrooms

    NARCIS (Netherlands)

    Lindequist, U.; Won Kim, H.; Tiralongo, E.; Griensven, van L.J.L.D.

    2014-01-01

    Since beginning of mankind nature is the most important source of medicines. Bioactive compounds produced by living organisms can be used directly as drugs or as lead compounds for drug development. Besides, the natural material can be used as crude drug for preparation of powder or extracts. Plants

  20. Medicinal Plants.

    Science.gov (United States)

    Phillipson, J. David

    1997-01-01

    Highlights the demand for medicinal plants as pharmaceuticals and the demand for health care treatments worldwide and the issues that arise from this. Discusses new drugs from plants, anticancer drugs, antiviral drugs, antimalarial drugs, herbal remedies, quality, safety, efficacy, and conservation of plants. Contains 30 references. (JRH)

  1. [Arsenic - Poison or medicine?].

    Science.gov (United States)

    Kulik-Kupka, Karolina; Koszowska, Aneta; Brończyk-Puzoń, Anna; Nowak, Justyna; Gwizdek, Katarzyna; Zubelewicz-Szkodzińska, Barbara

    2016-01-01

    Arsenic (As) is commonly known as a poison. Only a few people know that As has also been widely used in medicine. In the past years As and its compounds were used as a medicine for the treatment of such diseases as diabetes, psoriasis, syphilis, skin ulcers and joint diseases. Nowadays As is also used especially in the treatment of patients with acute promyelocytic leukemia. The International Agency for Research on Cancer (IARC) has recognized arsenic as an element with carcinogenic effect evidenced by epidemiological studies, but as previously mentioned it is also used in the treatment of neoplastic diseases. This underlines the specificity of the arsenic effects. Arsenic occurs widely in the natural environment, for example, it is present in soil and water, which contributes to its migration to food products. Long exposure to this element may lead to liver damages and also to changes in myocardium. Bearing in mind that such serious health problems can occur, monitoring of the As presence in the environmental media plays a very important role. In addition, the occupational risk of As exposure in the workplace should be identified and checked. Also the standards for As presence in food should be established. This paper presents a review of the 2015 publications based on the Medical database like PubMed and Polish Medical Bibliography. It includes the most important information about arsenic in both forms, poison and medicine. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. European Space Agency's Fluorescence Explorer Mission: Concept and Applications

    Science.gov (United States)

    Mohammed, G.; Moreno, J. F.; Goulas, Y.; Huth, A.; Middleton, E.; Miglietta, F.; Nedbal, L.; Rascher, U.; Verhoef, W.; Drusch, M.

    2012-12-01

    The Fluorescence Explorer (FLEX) is a dedicated satellite for the detection and measurement of solar-induced fluorescence (SIF). It is one of two candidate missions currently under evaluation by ESA for deployment in its Earth Explorer 8 program, with Phase A/B1 assessments now underway. FLEX is planned as a tandem mission with ESA's core mission Sentinel-3, and would carry an instrument, FLORIS, optimized for discrimination of the fluorescence signal in terrestrial vegetation. The FLEX mission would be the first to be focussed upon optimization of SIF detection in terrestrial vegetation, and using finer spatial resolution than is available with current satellites. It would open up a novel avenue for monitoring photosynthetic function from space, with diverse potential applications. Plant photosynthetic tissues absorbing sunlight in the wavebands of photosynthetically active radiation (400 to 700 nm) emit fluorescence in the form of red and far-red light. This signal confers a small but measurable contribution to apparent reflectance spectra, and with appropriate analysis it may be detected and quantified. Over the last 15-20 years, techniques for SIF detection have progressed from contact or near-contact methods using single leaves to remote techniques using airborne sensors and towers over plant canopies. Ongoing developments in instrumentation, atmospheric correction procedures, signal extraction techniques, and utilization of the SIF signal itself are all critical aspects of progress in this area. The FLEX mission would crystallize developments to date into a state-of-the-art pioneering mission targeting actual photosynthetic function. This compares to existing methods which address only potential function. Thus, FLEX could serve to provide real-time data on vegetation health and stress status, and inputs for parameterization of photosynthetic models (e.g. with measures of light-use efficiency). SIF might be correlated or modelled to photosynthetic rates or gross primary production — an important topic of research. An overview of the FLEX mission concept, applications of SIF, scientific challenges and opportunities will be presented.

  12. 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.

  13. 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.

  14. 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.

  15. Environmental medicine

    International Nuclear Information System (INIS)

    Steneberg, A.

    1996-01-01

    'Environmental medicine' deals with the manifold health problems from environmental factors of chemical, physical and psychosocial origin that are possible or have been observed. The book gives insight into the current state of knowledge of environmental medicine institutions, possibilities of diagnosis and therapeutic methods. It offers a systematic overview of pollutant sources and pollutant effects and points out, inter alia, syndromes that are discussed in connection with environmental factors: not only allergies and carcinogenous diseases but also symptom complexes that are hard to diagnose by ordinary methods such as the sick-building syndrome, multiple sensitivity to chemicals, electrosensitivity, amalgam intoxications, disorders due to wood preservatives and fungal diseases. The lingering course of a disease and a set of symptoms varying from one patient to another are the rule, not the exception, because environmental diseases are due above all to the chronic uptake of low pollutant doses (orig./MG) [de

  16. Home Health Care Agencies

    Data.gov (United States)

    U.S. Department of Health & Human Services — A list of all Home Health Agencies that have been registered with Medicare. The list includes addresses, phone numbers, and quality measure ratings for each agency.

  17. Nuclear medicine

    International Nuclear Information System (INIS)

    Sibille, L.; Nalda, E.; Collombier, L.; Kotzki, P.O.; Boudousq, V.

    2011-01-01

    Nuclear medicine is a medical specialty using the properties of radioactivity. Radioactive markers associated with vectors are used as a tracer or radiopharmaceutical for diagnostic purposes and/or therapy. Since its birth more than half a century ago, it has become essential in the care of many patients, particularly in oncology. After some definitions, this paper presents the main nuclear techniques - imaging for diagnostic, radiopharmaceuticals as therapeutic agents, intra-operative detection, technique of radioimmunoassay - and the future of this field. (authors)