PubMed Journals Articles About "Human Medicines European Public Assessment Report EPAR Prevenar" - Page: 4 RSS

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Showing "Human medicines European public assessment report EPAR Prevenar" PubMed Articles 76–100 of 44,000+

Eremothecium coryli bloodstream infection in a patient with acute myeloid leukemia: first case report of human infection.

Eremothecium coryli is a dimorphic fungus of the Saccharomycetes class. While species within this class are known to cause human infection, Eremothecium species have previously only been known as phytopathogens and never been isolated from a human sample. Here, we report the first known case of human E. coryli infection.

Are EMA, FDA and other international regulators talking to each other?

There is talk of regulatory collaboration worldwide to protect public health and allow patients timely access to medicines. Here we present the reality of the collaboration between EMA and FDA. This takes the form of near daily interactions, which may be less known outside of regulatory agencies. We present a review of what we call clusters, which involve EMA, FDA and many other agencies under the umbrella of confidentiality arrangements. Through a survey of participants, we identified about 30 clusters of ...

Public health: who, what, and why?

There has been renewed concern about the state of public health in Canada, with several recent articles in this journal suggesting that the discipline of public health is under threat and that there has been a significant erosion of its core infrastructure. We strongly agree with the need for a well-resourced formal public health system and preservation of capacity to carry out core public health functions, while also positing a complementary narrative that emphasizes the possibility for a broad notion of p...

The implementation of the bioequivalence certification policy in Chile: An analysis of market authorization data.

Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability.

The European Nucleotide Archive in 2019.

The European Nucleotide Archive (ENA, at the European Molecular Biology Laboratory's European Bioinformatics Institute provides open and freely available data deposition and access services across the spectrum of nucleotide sequence data types. Making the world's public sequencing datasets available to the scientific community, the ENA represents a globally comprehensive nucleotide sequence resource. Here, we outline ENA services and content in 2019 and provide an insight into se...

Late presentation among patients with human immunodeficiency virus infection in Turkey.

Late presentation of the patients with human immunodeficiency virus (HIV) infection is associated with less favourable treatment responses, more accelerated clinical progression, and a higher mortality risk. Although HIV prevalence is low in Turkey, it is steadily increasing and the information about late presentation among HIV-positives is limited. We aimed to analyze the status of late presentation among HIV-positive patients in Turkey.

The second information revolution: digitalization brings opportunities and concerns for public health.

The spread of the written word, facilitated by the introduction of the printing press, was an information revolution with profound implications for European society. Now, a second information revolution is underway, a digital transformation that is shaping the way Europeans live and interact with each other and the world around them. We are confronted with an unprecedented expansion in ways to share and access information and experiences, to express ourselves and communicate. Yet while these changes have un...

Medical Negligence, Systemic Deficiency, or Denial of Emergency Healthcare? Reflections on the European Court of Human Rights Grand Chamber Judgment in Lopes de Sousa Fernandes v. Portugal of 19 December 2017 and Previous Case-law.

On 19 December 2017 the Grand Chamber of the European Court of Human Rights (ECtHR) delivered a judgment in the Lopes de Sousa Fernandes v. Portugal case. The judgment may be described as one of the hard cases dealing with a healthcare context, as it aimed to clarify the scope of positive substantive state obligations under the European Convention on Human Rights and the conditions of international responsibility. This article explores the judgment against the wider background of the previous case-law of th...

Perceived sensitivity to medicines: a study among chronic medicine users in Norway.

Background Little is known about patients' Perceived Sensitivity to Medicines (PSM), "the belief that one is especially sensitive to the actions and side effects of medicines". Objective (i) To explore the extent of and factors associated with high Perceived Sensitivity to Medicines in a Norwegian population of chronic medicine users; (ii) to assess the psychometric characteristics of the tool to measure PSM. Setting Community pharmacies in the Oslo area, Norway. Method A cross-sectional, questionnaire-bas...

SHARP-Indicators Database towards a public database for environmental sustainability.

To initiate the achievement of an European-wide applicable public database for indicators of environmental sustainability of the diet, we developed the SHARP Indicators Database (SHARP-ID). A comprehensive description of the development of the SHARP-ID is provided in this article. In the SHARP-ID, environmental impact assessment was based on attributional life cycle analyses using environmental indicators greenhouse gas emission (GHGE) and land use (LU). Life cycle inventory data of 182 primary products wer...

Human neutrophil antigen frequency data for Malays, Chinese and Indians.

Human neutrophil antigens (HNAs) are implicated in several clinical disorders and their allelic variations have been reported for many populations. This new study was aimed to report the genotype and alleles frequencies of HNA-1, -3, -4 and -5 loci in Malays, Chinese and Indians in Peninsular Malaysia.

3D anthropometric assessment and perception of male body morphology in relation to physical strength.

The assessment of men's physical strength is an important part of human social perception, for which observers rely on different kinds of cues. However, besides previous studies being limited in considerable ways, as yet there is no comprehensive investigation of a range of somatometric measures in relation to both objectively measured and observer-perceived physical strength using valid stimuli.

Validity and reliability of the French version of Eating Assessment Tool (EAT-10).

To develop a French version of the Eating Assessment Tool (Fr EAT-10) and to assess its internal consistency, reliability and clinical validity.

Public health practitioners' perspectives of migrant health in an English region.

Migration is a complex and contested topic of public debate. Professionals working in public health must negotiate this politicised complexity, yet few studies examine the perspectives and practices of public health professionals in relation to migrant health. This study seeks to redress this by exploring how migrant health is conceptualised and addressed by public health professionals after a key transitional point in the reorganisation of public health in England and the public vote for the UK to leave th...

A cross-sectional study of the public health response to non-alcoholic fatty liver disease in Europe.

Non-alcoholic fatty liver disease (NAFLD) is a growing public health problem worldwide and has become an important field of biomedical inquiry. We aimed to determine whether European countries have mounted an adequate public health response to NAFLD and non-alcoholic steatohepatitis (NASH).

Regulatory Science and Innovation Programme for Europe (ReScIPE): a proposed model.

Regulatory science underpins the objective evaluation of medicinal products. It is therefore imperative that regulatory science and expertise remain at the cutting-edge so that innovations of ever-increasing complexity are translated safely and swiftly into effective, high-quality therapies. We undertook a comprehensive examination of the evolution of science and technology impacting on medicinal product evaluation over the next 5-10 years and this horizon-scanning activity was complemented by extensive sta...

10Kin1day: A Bottom-Up Neuroimaging Initiative.

We organized 10Kin1day, a pop-up scientific event with the goal to bring together neuroimaging groups from around the world to jointly analyze 10,000+ existing MRI connectivity datasets during a 3-day workshop. In this report, we describe the motivation and principles of 10Kin1day, together with a public release of 8,000+ MRI connectome maps of the human brain.

Using human epidemiological analyses to support the assessment of the impacts of coal mining on health.

The potential impacts of coal mining on health have been addressed by the application of impact assessment methodologies that use the results of qualitative and quantitative analyses to support their conclusions and recommendations. Although human epidemiological analyses can provide the most relevant measures of risk of health outcomes in populations exposed to coal mining by-products, this kind of studies are seldom implemented as part of the impact assessment methods. To review the use of human epidemiol...

Exposure to car smoking among youth in seven cities across the European Union.

In the United States and Canada, cars were found to be a major source of harmful secondhand smoke (SHS) exposure among youth. Little is known about the magnitude of this public health problem in European countries. We study SHS exposure in vehicles among adolescents across seven cities of the European Union (EU), with a particular focus on socioeconomic characteristics and smoking in adolescents' social environment.

Primary Care Assessment Tool applied to primary health care workers from Conchalí, Santiago.

The Chilean public health system is based on Primary Health Care (PHC), whose assessment is challenging due to the heterogeneity of services and multi-dimensionality of expected results. The Primary Care Assessment Tool was adapted and validated for Chile.

Factors influencing implementation of evidence-based interventions in public health systems - a model.

Evidence that health interventions work is not enough to ensure implementation into policy and practice. The complexity of public health systems requires more diverse actions. This paper proposes a conceptual model to enhance understanding of interlinking factors that influence the evidence implementation process.

Challenges and Opportunities for Therapeutics Targeting the Voltage-Gated Sodium Channel Isoform Na1.7.

Voltage-gated sodium ion channel subtype 1.7 (Na1.7) is a high interest target for the discovery of non-opioid analgesics. Compelling evidence from human genetic data, particularly the finding that persons lacking functional Na1.7 are insensitive to pain, has spurred considerable effort to develop selective inhibitors of this Na ion channel target as analgesic medicines. Recent clinical setbacks and disappointing performance of preclinical compounds in animal pain models, however, have led to skepticism aro...

The willingness to receive sexually transmitted infection services from public healthcare facilities among key populations at risk for human immunodeficiency virus infection in Bangladesh: A qualitative study.

In Bangladesh, community-based and peer-led prevention interventions for human immunodeficiency virus infection are provided to key populations (KPs) by drop-in centers (DICs), which are primarily supported by external donors. This intervention approach was adopted because public healthcare facilities were reportedly insensitive to the needs and culture of KPs, particularly with regard to the provision of sexually transmitted infection (STI) services. Nonetheless, in the absence of external funding, STI ser...

Uniportal video-assisted thoracic surgery lobectomy: a consensus report from the Uniportal VATS Interest Group (UVIG) of the European Society of Thoracic Surgeons (ESTS).

Our goal was to report the results of the first consensus paper among international experts in uniportal video-assisted thoracoscopic surgery (UniVATS) lobectomy obtained through a Delphi process, the objective of which was to define and standardize the main procedural steps, optimize its indications and perioperative management and identify elements to assist in future training.

Target 2035: probing the human proteome.

Biomedical scientists tend to focus on only a small fraction of the proteins encoded by the human genome despite overwhelming genetic evidence that many understudied proteins are important for human disease. One of the best ways to interrogate the function of a protein and to determine its relevance as a drug target is by using a pharmacological modulator, such as a chemical probe or an antibody. If these tools were available for most human proteins, it should be possible to translate the tremendous advance...

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