scholarly journals A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements

2014 ◽  
Vol 16 (3) ◽  
pp. 488-498 ◽  
Author(s):  
J. M. Sailstad ◽  
L. Amaravadi ◽  
A. Clements-Egan ◽  
B. Gorovits ◽  
H. A. Myler ◽  
...  
2017 ◽  
Vol 33 (S1) ◽  
pp. 176-176
Author(s):  
Kathi Apostolidis ◽  
Lydia Makaroff ◽  
Francesco De Lorenzo ◽  
Francesco Florindi

INTRODUCTION:In Europe, the work done by the European Commission and the European Network for Health Technology Assessment (EUnetHTA) has consolidated the role of Health Technology Assessment (HTA), and promises to better harmonize its impact across European Union (EU) countries. However, more work is needed to improve patient involvement in assessing new health technology, and in developing research priorities.METHODS:The European Cancer Patient Coalition (ECPC) developed a model for engagement of patients in HTA based on the experience from: •ECPC's ‘Value of Innovation in Oncology’ White Paper, which includes input from ECPC's membership•ECPC's leading role in the Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) study, funded by the Innovative Medicines Initiative, to develop guidelines on how patient-preference studies should be performed throughout the development of new medical treatments.RESULTS:The ECPC ‘Value of Innovation in Oncology’ White Paper was launched in 2017. The paper provides ECPC's policy position on key obstacles to equitable access to meaningful innovation. The paper recommends the establishment of an EU-wide HTA body to reduce delays and variations in access and to avoid duplication of effort by individual Member States. The paper also recommends that patients should be formally and routinely included in HTA policy and operations at EU and at national levels. These recommendations were also submitted to the European Commission's public consultation on strengthening EU cooperation on HTA.Through its work in PREFER, ECPC is helping to improve how patient preferences are measured and valued to capture the impact of health technology on patients daily life. Patient preferences are concerned with measuring how patients value components such as treatment end points, route of administration, treatment duration, treatment frequency, frequency of side-effects, price, and quality of life.CONCLUSIONS:Patient organization involvement in HTA is vital. Patient organizations offer unique insights, experiences, identify unmet needs, and can help to produce practical recommendations


2017 ◽  
Vol 15 (7) ◽  
pp. 986-997 ◽  
Author(s):  
Eva M. Szigethy ◽  
John I. Allen ◽  
Marci Reiss ◽  
Wendy Cohen ◽  
Lilani P. Perera ◽  
...  

Author(s):  
Dewan Md Zahurul Islam ◽  
Ross Jackson ◽  
Thomas Hagen Zunder ◽  
Arnaud Burgess

2018 ◽  
Author(s):  
Christina Emery ◽  
Mithu Lucraft ◽  
Agata Morka ◽  
Matteo Prandi ◽  
Ros Pyne

Open access book publishing is gaining momentum, with more than 10,000 titles published worldwide. But compared to the overall number of academic books that are produced, this is still a small percentage. With much research on the benefits to society from open access publication, what can we do to encourage more book authors to choose open access?Springer Nature is a leading academic book publisher – to date, we have published more than 550 open access books since launching OA book options in 2012. Feedback from our OA book authors has shown that metrics are important to them, as the data helps demonstrate the impact of their research to funders, and also supports conversations with their institutions for career progression. However, as highlighted in our white paper ‘The OA effect: How does open access affect the usage of scholarly books?’, some authors feel that there is a lack of information around metrics and book performance. This information may be critically important in helping authors consider the benefits of choosing to publish their book open access.Authors also state that one of the main obstacles to publishing more OA books through the gold route is funding; access to which varies globally and by discipline – a central theme that emerged at our researcher event during Academic Book Week 2018.Meanwhile, funders interviewed for ‘The OA Effect’ told us that they were keen to understand the impact of the OA books they had supported, but few had actually done so; many commented on the difficulties of measuring the impact of research.  In light of these findings, in 2018 we piloted a new “impact report”, based on metrics for an individual funder of OA books. The outcomes of this pilot impact report project will help the scholarly communications community to better understand how publishers can inform funders, authors and their institutions about the impact of their research, and on a wider scale. What are the challenges of sharing the benefits of OA book publishing with researchers across different disciplines, and how can we overcome these challenges?Our poster shows excerpts from the pilot impact report, quotes from authors and funders about research impact, and considers next steps.


Author(s):  
Mariano González-Delgado ◽  
Tamar Groves

This article analyzes the influence that the educational ideas proposed by UNESCO had on the development of the General Education Act (LGE) of 1970. More specifically, it attempts to establish the impact that this international organization had on the origin and development of the LGE during the Franco regime. To do so, the first part of the article studies the beginnings of UNESCO in Spain and how the educational conception that would give rise to one of the most important educational reforms of contemporary Spain was developed. In the second part, we examine the recommendations given by the «International Advisory Committee for the Reform of Education in Spain» regarding the debate generated by the Libro Blanco (White Paper). In the third part of the article we look at the Committe’s direct impact and the way its assessments guided the development of the LGE in its first years. This work aims to demonstrate that the LGE can be better understood as a reform born under the recommendations of UNESCO regarding the educational context originated within the framework of the Cold War and the Modernization Theory.


2013 ◽  
Vol 12 (2) ◽  
pp. 151
Author(s):  
Nelda Mouton ◽  
G.P. Louw ◽  
G.L. Strydom

Socio-economic and vocational needs of communities, governments and individuals change over the years and these discourses served as a compass for restructuring of higher institutions in South Africa from 1994. Before 1994, the claim to legitimacy for government policies in higher education rested on meeting primarily the interests of the white minority. From 1996 onwards, the newly established government considered education a major vehicle of societal transformation. The main objective had been to focus on reducing inequality and fostering internationalisation. Therefore, the rationale for the restructuring of South African universities included a shift from science systems to global science networks. Various challenges are associated with restructuring and include access, diversity, equity and equality. Thus, the restructuring and mergers between former technikons and traditional universities were probably the most difficult to achieve in terms of establishing a common academic platform, as transitional conditions also had to be taken into account and had a twin logic: It was not only the legacy of apartheid that had to be overcome but the incorporation of South Africa into the globalised world was equally important as globalisation transforms the economic, political, social and environmental dimensions of countries and their place in the world. Initially, the post-apartheid higher education transformation started with the founding policy document on higher education, the Report of the National Commission on Higher Education and this report laid the foundation for the 1997 Education White Paper 3 on Higher Education in which a transformed higher education system is described. Restructuring and mergers also had a far-reaching impact, positive and negative, on the various tertiary institutions. This article also reflects on the impact of restructuring and mergers of higher education and reaches the conclusion that higher education faces many more challenges than initially anticipated prior to transformation.


2020 ◽  
pp. 113-128
Author(s):  
Pedro Germano Leal

This white paper briefly outlines two co-dependent research initiatives: ‘Global Emblems’ and ‘Transmission and Intermediality: the impact of the emblematic culture in Ibero-America’. Both projects are in their initial stage of development, at Brown University. ▪ ‘Global Emblems’ is set to map, document and study the presence of emblems in material culture, around the world, and cross-link these occurrences with pre-existing digital collections of emblem books. The database will be fed by an international network of specialists, which is already active, with members in over ten countries and the support of the Society for Emblem Studies. The platform will allow searches by concepts (using Iconclass classification system) and a number of locations will allow users to ‘visit’ them through Virtual Reality (360 annotated photos). The database will be systematically studied through ‘thematic clusters’. Although at first glance the focus on emblems may seem narrow, emblems have a broad geographical and historical spread, which can be traced, and that provides the necessary data for the kind of analytical and interpretative study required in the second research initiative, which illustrates the importance of emblems within the wider frame of Latin American cultural history. ▪ ‘Transmission and Intermediality: the impact of the emblematic culture on the Early Americas’ will analyse the data from ‘Global Emblems’ in order to understand the role of emblems in the colonial process in the Americas. More specifically, this project will look at the ‘pictorial dispute’ in the New World, by examining the ‘pictorial turn’ from the ‘catecismos jeroglíficos’ to the displayed emblems in the 17th-century (many of them resulting from the remediation of European prints), and the ideological, political and sociological implications around the presence of these emblems in buildings and early-modern festivals.


Author(s):  
Paul Craig

The previous chapter considered the history and typology of EU administration. The present chapter focuses on the impact of resignation of the Santer Commission, which had profound significance for EU administration, and the controls to which it was subject. The resignation received front-page attention in the press, proof for those minded to believe it of the malaise which had long existed within that organization. Its downfall was prompted by the First Report of the Committee of Independent Experts. This was followed in quick succession by reforms instituted by Romano Prodi as the new President of the Commission, by the Committee of Independent Experts’ Second Report, by the White Paper on reform of the Commission and implementation of these reforms. An understanding of these developments is crucial in order to appreciate the current pattern of EU administration. This chapter will chart these developments leading to administrative reform, including the Financial Regulation, which established a constitutional framework for Union administration of the kind that had not existed hitherto. Subsequent chapters will analyse the provisions contained therein as they relate to different types of EU administration.


Author(s):  
Olivier Walusinski

On December 28, 1885, Gilles de la Tourette defended his doctoral thesis in medicine with his teacher, Jean-Martin Charcot, presiding over the jury. The subject, proposed by Charcot himself, involved studying footprints made on sheets of white paper and establishing gait anomalies during various stages of neurological disorders. Gilles de la Tourette spent 1884 and 1885 working on his thesis. His footprints graphical study, which may appear simplistic, is the first of its kind in neurology, making it innovative and valuable. It drew on similar orthopedic studies previously conducted in other European countries. These studies are reviewed here, and the genesis, technical aspects, and results of Gilles de la Tourette’s study are analyzed. The impact of his thesis is examined based on summaries published in the medical press and the fact that Gilles de la Tourette was awarded a prize by the Académie de Médecine for this work.


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