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PubMed Journals Articles About "Human Medicines European Public Assessment Report EPAR Firdapse" RSS

16:32 EDT 20th August 2018 | BioPortfolio

Human Medicines European Public Assessment Report EPAR Firdapse PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Human Medicines European Public Assessment Report EPAR Firdapse articles that have been published worldwide.

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Showing "Human medicines European public assessment report EPAR Firdapse" 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.

Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes.

Small and medium-sized enterprises (SMEs) are an important source of innovative medicines. Compared with their larger counterparts, they experience challenges as a result of insufficient human and financial resources that can hamper drug development and regulatory compliance. This analysis reviews the profile of major objections raised in applications for medicines for human use submitted by SMEs to the European Medicines Agency between 2011 and 2015 and their impact on the outcome of applications. It showe...

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.

Association between beliefs about medicines and self-medication with analgesics among patients with dental pain.

Self-medication with analgesics in dental pain management is a common practice as most of these medicines are available over-the-counter (OTC). The study aims to examine the relationship between beliefs about medicines and self-medication with analgesics in dental pain management in Malaysia. This cross-sectional study was conducted among conveniently sampled patients attending dental clinics, located in Kuala Lumpur, Malaysia to assess association between self-medication with analgesics and patient's belie...

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...

Does consumer medicines interest reflect medicines use? An Australian observational study comparing medicines call center queries with medicines use.

Consumers have questions about their medication but the nature of these concerns and how they reflect medication use is unknown.

The development of the public and professional policy committee.

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

ART in Europe, 2014: results generated from European registries by ESHRE: The European IVF-monitoring Consortium (EIM) for the European Society of Human Reproduction and Embryology (ESHRE).

What are the European trends and developments in ART and IUI in 2014 as compared to previous years?

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....

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

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...

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines.

Biological medicines nowadays have a great impact, as they offer treatment for  diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original  biotechnological medicine, whose patent has expired, and they comply with the  guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference on...

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).

Involving the public in epidemiological public health research: a qualitative study of public and stakeholder involvement in evaluation of a population-wide natural policy experiment.

Public involvement in research is considered good practice by European funders; however, evidence of its research impact is sparse, particularly in relation to large-scale epidemiological research.

The use of real-world data in cancer drug development.

Excitement about the dramatic increase in potential successful anticancer medicines in recent years is hampered by the high costs involved as well as the length of time traditional pathways take for regulatory approval. The translation of experimental clinical data into real-world evidence is also problematic. While the randomised controlled trial remains the gold standard for assessing efficacy and safety, there is increasing interest in the use of observational data to enable more rapid, informed and wide...

Indicators and Qualitative Assessment of Lung Cancer Management by Health Insurance Review and Assessment Service (HIRA) of Korea in 2015.

Cancer is the leading cause of death in the Republic of Korea and cancer death accounts for 27.8% of the total deaths, which is not only a social issue but also a concern for the public. Among the cancer death rates, lung cancer mortality account for 34 deaths per 100,000 populations, making it the number one cancer death rate. In a preliminary report on cancer death in 2012, the lung cancer mortality ratio showed the regional variation indicating that there were differences in the qualitative level and the...

European Public Health News.

European Public Health News.


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