An ongoing study has been set up by the CMR International Institute for Regulatory Science to record and analyze the regulatory procedures for the authorization of new medicines in 13 key countries, outside the ICH regions, where the pharmaceutical market is expanding or the regulatory agency plays an important role in regional development. These countries are Argentina, Brazil, Mexico, Egypt, Saudi Arabia, South Africa, China, India, Indonesia, Malaysia, Singapore, South Korea, and Chinese Taipei. In the study, data were collected from senior personnel in the national agencies and from multinational pharmaceutical companies on the review and assessment processes for new active substances (NASs) and major line extensions (MLEs). The quality measures being applied by the agencies to monitor those procedures were also recorded. The design of the study collected information for a status report at one time point, as summarized here, but also provides the basis for recording and benchmarking the progress and changes made by the agencies over time. A cross-comparison of information from the authorities indicated that regulatory aspirations, barriers, and priorities are essentially similar across agencies. The review steps are also similar although there are major differences in the assessment process. Most agencies are using risk stratification methods for their review of new medicines, based on the level of regulatory scrutiny the product has already undergone by agencies elsewhere. There is an awareness of the importance of building quality into agencies' regulatory processes and practices and this is a changing and evolving area.
Use of CTA provided a highly detailed depiction of the vasculature of the distal portion of the equine forelimb. This was a safe technique and should be useful in the evaluation of the blood supply to the distal portion of the forelimb.
This article explores a paradox at the heart of New Left populism in Bolivia and Ecuador – namely, the election of populist leaders in movement societies. Employing Laclau's theory about the emergence of populism, it demonstrates how social movements, not charismatic leaders, first constructed the popular identities that laid the foundations for these regimes. In re-examining theories of populism in light of these cases, this article suggests that populism's transformative and counter-hegemonic potential needs to be given renewed attention, and that the central role of charismatic leadership should be qualified in terms of the origins of populist identity formation.
Purpose
– The purpose of this paper is to present a theoretical overview of the field of knowledge transfer and educational change and a discussion of the issues raised in the six papers in this special edition.
Design/methodology/approach
– A theoretical analysis of the field of knowledge transfer.
Findings
– The six papers consider issues such as the interplay of ideas between British and Indian educationalists, post-war debates over literacy standards, the use of curriculum materials for the process of citizen formation, the influence of international exchanges in the education of adolescents for citizenship, Vigotsky and the transfer of knowledge across time, space, culture, disciplines and networks, and the way constructions of Chinese identity within history books were shaped by knowledge processes that transcended nation states.
Originality/value
– This special issue of the History of Education Review engages with new approaches that have become available to historians in the past decade illustrating how they might be applied for the first time to key issues in the history of education across colonial and state borders. It addresses questions about the movement of knowledge across national and cultural boundaries, and examines key problems facing educators in a range of colonial and postcolonial contexts.
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