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

18:42 EDT 17th September 2019 | BioPortfolio

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Showing "Human medicines European public assessment report EPAR Galafold" PubMed Articles 1–25 of 44,000+

Cost-effectiveness of public health interventions against human influenza pandemics in France: a methodological contribution from the FLURESP European Commission project.

The FLURESP project is a public health project funded by the European Commission with the objective to design a methodological approach in order to compare the cost-effectiveness of existing public health measures against human influenza pandemics in four target countries: France, Italy, Poland and Romania. This article presents the results relevant to the French health system using a data set specifically collected for this purpose.


Rapid assessment of enhanced safety surveillance for influenza vaccine.

The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season.

European Medicines Agency-Health Technology Assessment Parallel Consultation Platform: An Industry Perspective.


The financial burden of non-communicable diseases in the European Union: a systematic review.

Non-communicable diseases (NCDs) impose a significant and growing burden on the health care system and overall economy of developed (and developing) countries. Nevertheless, an up-to-date assessment of this cost for the European Union (EU) is missing from the literature. Such an analysis could however have an important impact by motivating policymakers and by informing effective public health policies.

Corrigendum to: Assessment of developmental risk information on medicines for inclusion on the WHO's Essential Medicines List.

Does public report card matter? A 10-year interrupted time series analysis on total knee replacement.

There is a lack of evidence that shows whether a report card can improve health outcomes in terms of infection rates or unscheduled readmission by using rigorous methods to evaluate its impact.

The Impact of Price Negotiations on Public Procurement Prices and Access to 8 Innovative Cancer Medicines in a Middle-Income Country-The Case of Mexico.

To mitigate the effect of high prices, in 2008 Mexico established a commission that negotiates single procurement prices for patented medicines in the public sector.

Added value of human biomonitoring in assessment of general population exposure to xenobiotics.

Human biomonitoring (HBM) has a wide range of applications and long tradition both in health care and the field of public health. Its major advantage is the integration of all exposure routes and sources. Since HBM information is an integrated exposure finding it offers the opportunity to trace and mimic a realistic exposure scenario. It reduces the number of assumptions that need to be made when estimating exposure and thus helps to reduce the uncertainties in exposure science. In spite of some challenges,...

Assessment of technical efficiency of public hospitals in Turkey.

Turkish public hospitals have been subjected to health care reform because of increasing cost pressure, inequities in access to health care, poor quality of care and limited patient responsiveness in the last three decades. This study investigates the impact of recent hospital reforms on the efficiency of public hospitals.

The European Medicines Agency's scientific opinion on oral fexinidazole for human African trypanosomiasis.

Mutual recognition in the European system: A blueprint for increasing access to medicines?

The European regulatory system for approval of medicinal products is globally recognised as a unique platform for regulatory work-sharing and mutual recognition. As such, it potentially serves as a role model for regulatory capacity building worldwide. While focusing on mutual recognition and decentralised procedures, this paper illustrates key success factors and structures allowing for the reliance-based authorisation of medicines in the European Economic Area from the perspective of a national regulatory...

A Quantitative Public Health Risk Assessment Tool for Planning for At-Risk Populations.

The Drexel University Center for Public Health Readiness and Communication developed a quantitative public health risk assessment tool that has been used in Pennsylvania and across the United States. The tool assesses hazard impacts on health care and public health metrics and incorporates the planning needs of at-risk populations. The flexible platform using Microsoft Excel allows planners to customize hazard assessment and use jurisdiction-specific data. Findings from the risk assessment can guide plannin...

Access to and use of medicines in the Annapurna region of Western Nepal and possible impacting factors.

Improving access to medicines is a major healthcare challenge for low-income countries because the problem traverses health systems, society and multiple stakeholders. The Annapurna region of Nepal provides a valuable case study to investigate the interplay between medicines, society and health systems and their effects on access to and use of medicines. Government health facilities and international aid organizations provide some healthcare in the region, communities participate actively in healthcare orga...

Monitoring evidence on overall survival benefits of anticancer drugs approved by the European Medicines Agency between 2009 and 2015.

The introduction provisional approval strategies increases the approval of anticancer drugs with ambiguous benefit-risk profiles. Thus, in many instances, there is lacking evidence about overall survival (OS) at the time of marketing authorisation. Our objective was to monitor and characterise therapies with ambiguous benefit-risk profiles and identify any postapproval updates on median OS after at least 3 years of approval by the European Medicines Agency (EMA).

Kidney graft survival of >25 years: A single center report including associated graft biopsy results.

We appreciate the valuable comments to our report. Epitope matching or total eplet mismatch could indeed be an attractive explanation for the favorable outcome of the subjects in our report, at least for those without rejection. This relatively novel view of immunological assessment could be very important although its true value remains to be determined.

The availability, prices and affordability of essential medicines in Malawi: A cross-sectional study.

The Malawian government recently introduced cost-covering consultation fees for self-referral patients in tertiary public hospitals. Previously, patients received medicines free of charge in government-owned health facilities, but must pay elsewhere. Before the government implements a payment policy in other areas of health care, it is important to investigate the prices, affordability and availability of essential medicines in Malawi.

Stock-outs of antiretroviral and tuberculosis medicines in South Africa: A national cross-sectional survey.

HIV and TB programs have rapidly scaled-up over the past decade in Sub-Saharan Africa and uninterrupted supplies of those medicines are critical to their success. However, estimates of stock-outs are largely unknown. This survey aimed to estimate the extent of stock-outs of antiretroviral and TB medicines in public health facilities across South Africa, which has the world's largest antiretroviral treatment (ART) program and a rising multidrug-resistant TB epidemic.

Towards a "prescribing license" for medical students: development and quality evaluation of an assessment for safe prescribing.

This report describes the development and validation process of an assessment with national consensus in appropriate and safe pharmacotherapy.

A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines.

European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met (consent would be impractical or unfeasible, yet the trial would have high social value and pose no or minimal risk to participants). We aimed to identify whether any such trials of medicines were being conducted in Europe.

The implementation of RAAF in the OECD QSAR toolbox.

The Read-Across Assessment Framework (RAAF) was developed by the European Chemical Agency (ECHA) as an internal tool providing a framework for a consistent, structured and transparent assessment of grouping of chemicals and read-across. Following a RAAF-based evaluation, also developers and users of read-across predictions outside ECHA can judge whether their read-across rationale is sufficiently robust from a regulatory perspective. The aim of this paper is to describe the implementation of RAAF functional...

Evaluation of prices, availability and affordability of essential medicines in Lahore Division, Pakistan: A cross-sectional survey using WHO/HAI methodology.

Inadequate access to medicines affected by un-controlled prices is a major concern in developing countries, including Pakistan, which lacks comprehensive data on medicine prices. Thus, the objective of this study was to evaluate the prices, availability and affordability of essential medicines in Lahore division, Pakistan. The survey was undertaken from November, 2016 till March, 2017 by including 50 medicines, 14 from the WHO/HAI core list and 36 supplementary medicines from national essential medicine lis...

HIV in Canada-Surveillance Report, 2017.

Human immunodeficiency virus (HIV) is a global public health issue with an estimated 1.8 million people newly infected in 2017.

Investigation of medicines consumption and disposal in Brazil: A study case in a developing country.

The incorrect disposal of medicines can be harmful to the environment. Here, we aim to understand the consumption and disposal of medicines in Brazil using online forms. 64% of the respondents have the habit to self-medicate. 66% of respondents dispose the disused or expired medicines in the garbage. 71.9% of respondents never receive any information about correct disposal of medicines. 95.2% of respondents believe that residues of medicines can be harmful to the environment. Environmental education can pro...

Industrial perceptions of medicines regulatory harmonization in the East African Community.

Medicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration o...

How to Harness Big Data for the Benefit of Patients.

IMI is a large public private partnership which has committed Euro 5 Billion from the European Commission, the European Pharmaceutical sector and other partners, to enable and accelerate bringing medical innovation to patients. IMI is now 10 years old and already has changed the ecosystem and way of working in developing innovative medicines across the public/private divide. Big data represents a significant piece of this investment and projects in this area are attempting to provide solutions to major chal...


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