The role of regulatory purpose in determining the appropriate comparator

2017 ◽  
pp. 38-96
Keyword(s):  
Regulatory Purpose

scholarly journals Obstacles in Haemocompatibility Testing

Scientifica ◽  
2013 ◽  
Vol 2013 ◽  
pp. 1-14 ◽  
Author(s):  
W. van Oeveren
Keyword(s):  
Material Properties ◽  
Surface Interactions ◽  
Test Results ◽  
Test Models ◽  
Regulatory Purpose ◽  
Biomaterial Surfaces ◽  
Air Interfaces

ISO 10993-4 is an international standard describing the methods of testing of medical devices for interactions with blood for regulatory purpose. The complexity of blood responses to biomaterial surfaces and the variability of blood functions in different individuals and species pose difficulties in standardisation. Moreover,in vivoorin vitrotesting, as well as the clinical relevance of certain findings, is still matter of debate. This review deals with the major remaining problems, including a brief explanation of surface interactions with blood, the current ISO 10993 requirements for testing, and the role ofin vitrotest models. The literature is reviewed on anticoagulation, shear rate, blood-air interfaces, incubation time, and the importance of evaluation of the surface area after blood contact. Two test categories deserve further attention: complement and platelet function, including the effects on platelets from adhesion proteins, venipuncture, and animal derived- blood. The material properties, hydrophilicity, and roughness, as well as reference materials, are discussed. Finally this review calls for completing the acceptance criteria in the ISO standard based on a panel of test results.

Gutting a good idea

2018 ◽  
Author(s):  
John Kendall
Keyword(s):  
Police Misconduct ◽  
Archival Research ◽  
Home Office ◽  
Police Interrogation ◽  
Policy Issues ◽  
Regulatory Purpose ◽  
History Of ◽  
The Government ◽  
Deaths In Custody

This chapter provides a critical and analytical history of custody visiting, centring on the policy issues, and compiled from desk and archival research. Michael Meacher MP made the first proposals for custody visiting in 1980, and in 1981 the Scarman Report on the Brixton riots adopted this idea and included a recommendation for a statutory scheme of custody visiting. The scheme would provide for the supervision of the conditions of police interrogation and detention. The government declined to implement the proposals. However the government encouraged the growth of custody visiting from 1984 on the rather haphazard and unofficial basis known as ‘lay visiting’, run by police authorities. A statutory scheme was introduced in 2003. Over the whole period to date, the powerful influence of the police, and the Home Office following their views, have eroded the original regulatory purpose of custody visiting, and has airbrushed out the role of custody visiting as a deterrent to police misconduct leading to deaths in custody.

The role of regulatory purpose under Articles III: 2 and 4 – toward consistency between negotiating history and WTO jurisprudence

2012 ◽  
Vol 11 (1) ◽  
pp. 81-118 ◽  
Author(s):  
WEIHUAN ZHOU
Keyword(s):  
National Treatment ◽  
Regulatory Purpose ◽  
Preparatory Work

AbstractAfter years of debate, the issues of whether and where (i.e. under which legal element) regulatory purposes should be considered under Article III:2 and Article III:4 of the GATT – the most invoked provisions of the National Treatment rule – remain unsolved. This article submits that the preparatory work of the National Treatment rule provides significant interpretative guidance on the issues. In relation to Article III:2, 2nd sentence and Article III:4, the WTO jurisprudence has achieved consistency with the interpretative guidance. However, by expanding the reach of Article III:2, 1st sentence to origin-neutral fiscal measures whereas rejecting the relevance of regulatory purposes to the determination of whether such measures are in violation of that sentence, the WTO judges have failed to respect the functions of Article III:1 and Article III:2, 1st sentence as contemplated by the draftsmen. To remedy this failure, this article proposes that the WTO adjudicators should either approve formal purpose inquiries under Article III:2, 1st sentence, or, alternatively, confine the application of that sentence to origin-specific measures only.

Role of dactinomycin in the improved survival of children with Wilms' tumor

JAMA ◽  
1966 ◽  
Vol 195 (12) ◽  
pp. 1005-1009 ◽  
Author(s):  
D. J. Fernbach
Keyword(s):  
Wilms Tumor

Role of the allergist in diagnosis and management of patients with uveitis

JAMA ◽  
1966 ◽  
Vol 195 (3) ◽  
pp. 167-172 ◽  
Author(s):  
T. E. Van Metre
Keyword(s):  
Diagnosis And Management

The power of norms to sway fused group members

2018 ◽  
Vol 41 ◽  
Author(s):  
Winnifred R. Louis ◽  
Craig McGarty ◽  
Emma F. Thomas ◽  
Catherine E. Amiot ◽  
Fathali M. Moghaddam
Keyword(s):  
Evolutionary Anthropology ◽  
Normative Systems ◽  
Violent Extremism ◽  
Identity Fusion ◽  
Group Members

AbstractWhitehouse adapts insights from evolutionary anthropology to interpret extreme self-sacrifice through the concept of identity fusion. The model neglects the role of normative systems in shaping behaviors, especially in relation to violent extremism. In peaceful groups, increasing fusion will actually decrease extremism. Groups collectively appraise threats and opportunities, actively debate action options, and rarely choose violence toward self or others.

Elaborating the role of reflection and individual differences in the study of folk-economic beliefs

2018 ◽  
Vol 41 ◽  
Author(s):  
Kevin Arceneaux
Keyword(s):  
Decision Making ◽  
Individual Differences ◽  
Cognitive Processes ◽  
Evolutionary History ◽  
Behavioral Responses ◽  
History Of ◽  
Economic Beliefs

AbstractIntuitions guide decision-making, and looking to the evolutionary history of humans illuminates why some behavioral responses are more intuitive than others. Yet a place remains for cognitive processes to second-guess intuitive responses – that is, to be reflective – and individual differences abound in automatic, intuitive processing as well.

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