Similar to the 2006 consensus statement on the standardization of growth hormone (GH) assays (1 ), the guidelines regarding improvement of assay comparability in a recent consensus statement in Clinical Chemistry (2 ) are limitedto the recommendation to the recommendation of common use of the Second International Standard for Somatropin (IS 98/574), although it is recognized that discrepancies ...

Unsafe medical care is a major source of disabling injuries and death throughout the world. The failure to notify, follow up, and action critical results, which signify life threatening situations, is of particular concern and may cause avoidable morbidity and mortality. International accreditation standards require pathology laboratories to have a system for the timely and reliable communicati...

Method validation is an important requirement for any package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Analytical methods should be validated, including methods published in the relevant pharmacopoeia or other recognized standard references. The suitability of all test methods used should always be verifie...

The Organization for Economic Cooperation and Development's (OECD) Working Group for the Harmonization of Regulatory Oversight (Working Group) has taken the opportunity over the last several years to identify the challenges to environmental risk assessment of transgenic organisms, particularly plants. These initiatives have included most importantly, a report to the G8, the Rapporteur's Report ...

There are many activities currently being undertaken in the eld of laboratory medicine under the broad heading of “harmonization”. These include traceability of results to international reference standards, processes to align results from assays where traceability has not been achieved (analytical harmonization) and international or national clinical guidelines based on studies from many parts...

In recent years, there is a growing interest in the study of cross-national policy convergence, which is closely related to research on the domestic impact of globalisation. Yet we still have a limited understanding of the phenomenon of policy convergence. Does the strong growth of economic and institutional interlinkages between nation states lead to increasingly similar policies across countr...

This paper examines the role of occupational hygiene in the overall framework of occupational health. It draws attention to the unique combination of required individual science subjects, and to the way in which occupational hygiene science contributes to the practice of occupational hygiene in the real world. It focuses in particular on occupational exposure standards. The paper provides, as a...

This paper analyzes optimal copyright levies in a representative consumer model and derives welfare implications for harmonization of levy rates. When the policymakers place enough weight on the interests of collecting societies, harmonization could lead to a reduction in social welfare. When countries are asymmetric, the country with a larger proportion of foreign consumption and more ine¢ cie...