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Author: N. McAuslane
Publisher: Springer Science & Business Media
ISBN: 9401148740
Category : Medical
Languages : en
Pages : 174
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Book Description
At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as 'what target should be set for the review of new medicines?' and `how can quality be assured?' are now considered to be of critical importance. The twelfth CMR International Workshop, held in January 1997, provided the opportunity for Regulatory Authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarises the many suggestions that were debated at the Workshop, and includes chapters on measuring performance, and on the integration of quality into the review process.
Author: N. McAuslane
Publisher: Springer Science & Business Media
ISBN: 9401148740
Category : Medical
Languages : en
Pages : 174
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Book Description
At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as 'what target should be set for the review of new medicines?' and `how can quality be assured?' are now considered to be of critical importance. The twelfth CMR International Workshop, held in January 1997, provided the opportunity for Regulatory Authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarises the many suggestions that were debated at the Workshop, and includes chapters on measuring performance, and on the integration of quality into the review process.
Author: Susan A. Griffiths
Publisher: Springer Science & Business Media
ISBN: 9401148767
Category : Medical
Languages : en
Pages : 208
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Book Description
Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline `Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264042946
Category :
Languages : en
Pages : 333
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Book Description
This review analyses the challenges of strengthening regulatory governance in Brazil to improve economic growth, with appropriate regulatory frameworks for core infrastructure sectors.
Author:
Publisher: DIANE Publishing
ISBN: 1428978488
Category :
Languages : en
Pages : 93
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Book Description
Author: Penny Gleeson
Publisher: Taylor & Francis
ISBN: 1040297072
Category : Law
Languages : en
Pages : 210
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Book Description
This book develops a theoretical framework for examining and assessing the regulatory arrangements for medical products. Since the first half of the 20th century, the regulation of pharmaceuticals, medical devices and, more recently, biologicals have been controlled in many jurisdictions by specific regulatory regimes and agencies. Their regulatory mandates are similar – to ensure the quality, safety and efficacy of medical products. This book provides a timely and relevant assessment of the complexities of medical regulatory regimes, by drawing on a particular theory of political legitimacy. In this respect, the book adopts a ‘dialogic’ approach – according to which a shared set of normative beliefs and values are formulated – as a theoretical ‘tool’ to identify deficiencies in the regulatory arrangements for medical products. Drawing on several Australian cases studies, characterised by divergent normative perspectives, the book develops its dialogic approach in order to challenge the usual legitimation of regulatory regimes from the perspective of science alone. Specifically, it maintains that such regimes need to embrace a normative pluralism that admits a diversity of types and sources of knowledge. This evaluation of the increasingly influential domain of medical regulation will appeal to a range of scholars and practitioners working in law, public health, politics and science and technology studies.
Author:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 284
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Book Description
Author: Wright, Katherine Landau
Publisher: IGI Global
ISBN: 1668482630
Category : Language Arts & Disciplines
Languages : en
Pages : 344
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Book Description
Assessing Disciplinary Writing in Both Research and Practice tackles the challenge of measuring writing skills in specific content areas, which is crucial for preparing students to communicate as field experts and for their future careers. Edited by Katherine Wright, Associate Professor of Literacy and Language at Boise State University, and Tracey Hodges, Founder and Lead Consultant of The Empowering Advocate, this book provides solutions by bringing together validated measures and practical assessment strategies that can be used in both research and instruction. The book's theoretical foundations cover multimodal disciplinary writing, assessing disciplinary writing versus content-area writing, and using assessment as a tool for disciplinary writing instruction. Practical methods for assessing writing in social studies, science, mathematics, English and language arts, and other genres at the elementary, middle, and high school levels are included, as well as assessment strategies for specific populations of students such as undergraduate students, English learners, gifted and talented students, special needs students, and incarcerated students. This highly valued reference is essential for academic scholars, K12 teachers, and educational researchers who want to improve writing instruction and research in content- and discipline-specific areas. By providing validated measures and methods for assessing disciplinary writing, this edited book helps bridge the gap between research and practice and enables practitioners to better measure student growth and improve writing instruction. This publication is the first step towards advancing research and improving writing instruction in content- and discipline-specific areas.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264443746
Category :
Languages : en
Pages : 109
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Book Description
This report uses the OECD Performance Assessment Framework for Economic Regulators (PAFER) to assess both the internal and external governance of Ireland’s Environmental Protection Agency (EPA).
Author: OECD
Publisher: OECD Publishing
ISBN: 9264686762
Category :
Languages : en
Pages : 92
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Book Description
The review discusses OSITRAN's good practices, analyses the key drivers of its performance, and proposes an integrated reform package to help the regulator prepare for the future.
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Transportation, Housing and Urban Development, and Related Agencies
Publisher:
ISBN:
Category : Administrative agencies
Languages : en
Pages : 1882
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Book Description
