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Showing "Human medicines European public assessment report EPAR PecFent" PubMed Articles 1–25 of 45,000+

Ensuring supplies of medicines during pandemics in terms of public procurement.

This article describes and comments on contemporary legal regulations concerning the supply of medicines during pandemics in terms of public procurement.

Pregnancy outcomes after maternal use of thiocolchicoside: A case series.

The 2014 report by European Medicines Agency (EMA) restricted the use of thiocolchicoside for all reproductive-age women. In this study, we aim to expand the systematically-collected human data and discuss it within the frame provided by this report.

Current and future cardiovascular disease risk assessment in the European Union: an international comparative study.

Risk assessment is central to primary prevention of cardiovascular disease (CVD), but there remains a need to better understand the use of evidence-based interventions in practice. This study examines: (i) the policies and guidelines for risk assessment in Europe, (ii) the use of risk assessment tools in clinical practice and (iii) the barriers to, and facilitators of, risk assessment.

Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.

Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless granted a waiver. We aimed to evaluate the availability of paediatric trial results from studies required under the Paediatric Regulation for new medicines authorised in the EU.

Safe administration of medicines: learning from our mistakes.

This issue of the Dutch Journal of Medicine (NTvG) features a review article by Van der Veen et al. on safe administration of medicines in hospitals. This topic is part of an increased focus on patient safety that started at the beginning of the 21st century, following publication of the renowned report 'To err is human'. Now, almost 20 years later, we are a little disappointed that there is still no set of interventions that can be implemented to guarantee safe administration of medicines in hospitals. Why...

Essential medicines for emergency care in Africa.

Essential medicines lists (EMLs) are efficient means to ensure access to safe and effective medications. The WHO has led this initiative, generating a biannual EML since 1977. Nearly all countries have implemented national EMLs based on the WHO EML. Although EMLs have given careful consideration to many public health priorities, they have yet to comprehensively address the importance of medicines for treating acute illness and injury.

A review of the contributions of cross-discipline collaborative European IMI/EFPIA research projects to the development of Replacement, Reduction and Refinement strategies.

The objective of this review is to report on whether, and if so, how, scientific research projects organised and managed within collaborative consortia across academia and industry are contributing to the Three Rs (i.e. reduction, replacement and refinement of the use of animals in research). A number of major technological developments have recently opened up possibilities for more direct, human-based approaches leading to a reassessment of the role and use of experimental animals in pharmacological resear...

Improving the Safety Assessment of Chemicals and Drug Candidates by the Integration of Bio-informatics and Chemoinformatics Data.

The application of read-across and in silico tools for regulatory decision-making has been limited for pharmaceutical compounds to the assessment of genotoxic impurity. In contrast, the broad availability of toxicity data for industrial chemicals has triggered regulatory frameworks for read-across (e.g. ECHA read-across assessment framework), software tools and public databases for an automated process of gap filling for safety assessment framework. This MiniReview provides an overview of the currently exis...

Listen to the public and fulfil their information interests - Translating vaccine communication research findings into guidance for regulators.

Regulatory authorities have a crucial role in communicating about vaccines they license. In terms of content and timing, their communication to the public is usually driven by data on quality, safety and efficacy. However, concerns over safety and vaccine hesitancy have emerged in some communities of various countries, and this demands a new approach to communication, starting with listening to the public debate. Reviewing communication research findings, coming in particular from the cognitive, decision-ma...

The development of the public and professional policy committee.

Re: Availability of Evidence of Benefits on Overall Survival and Quality of Life of Cancer Drugs Approved by European Medicines Agency: Retrospective Cohort Study of Drug Approvals 2009-2013.

Availability and affordability of blood pressure-lowering medicines and the effect on blood pressure control in high-income, middle-income, and low-income countries: an analysis of the PURE study data.

Hypertension is considered the most important risk factor for cardiovascular diseases, but its control is poor worldwide. We aimed to assess the availability and affordability of blood pressure-lowering medicines, and the association with use of these medicines and blood pressure control in countries at varying levels of economic development.

A Right to Access to Emergency Health Care: The European Court of Human Rights Pushes the Envelope.

This article argues that the European Court of Human Rights (ECtHR) seems to have recently acknowledged that there is a right to access to emergency health care in the member states of the Council of Europe. The Chamber of the ECtHR found that a state's failure to design a regulatory framework that guarantees access to health care in emergency situations violates the substantial limb of Article 2 European Convention on Human Rights (ECHR) that protects the right to life. It is argued that the newly establis...

Strengthening data to inform building code improvements: time for an international dialogue: Editorial for the European Journal of Public Health.

A modified Delphi study to determine the level of consensus across the European Union on the structures, processes and desired outcomes of the management of polypharmacy in older people.

Inappropriate use of multiple medicines (inappropriate polypharmacy) is a major challenge in older people with consequences of increased prevalence and severity of adverse drug reactions and interactions, and reduced medicines adherence. The aim of this study was to determine the levels of consensus amongst key stakeholders in the European Union (EU) in relation to aspects of the management of polypharmacy in older people.

Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patients.

Since 2010, the European Medicines Agency (EMA) has provided access to clinical study reports (CSRs). We requested CSRs for randomized controlled trials (RCTs) of erythropoiesis-stimulating agents (ESAs) in cancer patients from EMA and identified RCT publications with literature searches. We assessed CSR availability and completeness, the impact of unreported and unpublished data obtained from CSRs on the effects of ESAs on quality of life (QoL) of cancer patients, and discrepancies between data reported in...

When is a medicine unwanted, how is it disposed, and how might safe disposal be promoted? Insights from the Australian population.

Objective The aim of the present study was to explore disposal practices of unwanted medicines in a representative sample of Australian adults, compare this with previous household waste surveys and explore awareness of the National Return and Disposal of Unwanted Medicines (RUM) Project.Methods A 10-min online survey was developed, piloted and conducted with an existing research panel of adult individuals. Survey questions recorded demographics, the presence of unwanted medicines in the home, medicine disp...

A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016.

Quantitative risk assessment of tobacco products: A potentially useful component of substantial equivalence evaluations.

Quantitative risk assessment (QRA), a scientific, evidence-based analytical process that combines chemical and biological data to quantify the probability and potential impact of some defined risk, is used by regulatory agencies for decision-making. Thus, in tobacco product regulation, specifically in substantial equivalence (SE) evaluations, QRA can provide a useful, practical, and efficient approach to address questions that might arise regarding human health risk and potential influence on public health....

Public Health Practice - Results of the Working Group 12 of the Forum Future Public Health, Berlin 2016.

This report focuses on the topic of Public Health in practice. The article summarizes the discussion of the Working Group 12. A first diagram shows how broad the definition of "Public Health practice" can be. Challenges as well as visions were articulated. In order to ensure individual and diverse health promotion for all, public health must be integrated as a central vision for the future in the daily routine and in the various living environments of the people as part of social life. To achieve this goal,...

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.

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-th...

Essential medicines availability is still suboptimal in many countries: A scoping review.

To identify uses of WHO Model list of essential medicines (EM) and summarize studies examining essential medicines (EM) and national EM lists (NEMLs).

Promoting public health in nutrition: Nutri-Score and the tug of war between public health and the food industry.

Adolescents' knowledge and perception of risk toward medicines.

Adolescents often start to use medicines independently without having sufficient knowledge or previous experience, which can lead to the inappropriate use of the medicines.

Design of Brand Names of Medicines Considering Subjects' Preferences.

Only recently, regulations on the names of medicines were developed. Regulations are mainly focused on avoiding the approval of medicine names that may be confusing to others. Furthermore, legal requirements do not include testing for human factors, such as potential users' preferences.

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