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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
Get Book Here
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:
Publisher: BoD – Books on Demand
ISBN: 0850142318
Category : Medical
Languages : en
Pages : 184
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Book Description
This book provides a detailed overview covering all aspects of drug development, from synthesis and manufacturing to delivery strategies, and ensuring a thorough understanding of the field. This book will show how new drugs are made. The chapters also give inside information on regulatory authorities so that drugs meet the necessary standards for quality. Drug Development and Safety effortlessly switches over to drug delivery technologies by exploring ground-breaking methods that are changing medicine forever. Controlled-release drug delivery systems represent some of the current breakthroughs while using nanoparticles for treating cancer stands among other recent therapeutic innovations. Each chapter has been authored by a leading scientist or expert in that particular field, and various viewpoints will be presented to provide a fuller understanding of the subjects concerning the safety of drugs. The book will be for chemists, pharmacists, and biologists, and it will be their only guide while navigating the challenging pharmaceutical science terrain.
Author: Stephen Weatherill
Publisher: Bloomsbury Publishing
ISBN: 1847313671
Category : Law
Languages : en
Pages : 462
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Book Description
The discourse of 'Better Regulation' is a hot topic, intimately associated with the drive for cost savings and a more efficient economy. In the UK and in the EU, rule-makers have lately endeavoured to achieve a more satisfactory balance between the demands of proper protection from market failure and inequity on the one hand, and commercial freedom and the potential for innovation on the other. But who is the regulator listening to, and what effect does this have on the regulatory pattern governing the integrating EU market? What is best practice in the matter of regulatory assessment. The essays in this collection explore these and other questions and will foster greater understanding of UK and EU regulation, the accountability issues involved, and problems of enforcement. It is no coincidence that since efforts to construct a Constitution for Europe have stalled the attention of policy-makers, politicians and the business community has turned instead to the quest for Better Regulation - or perhaps, it might be said, a "Better European Union".
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:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 388
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Book Description
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Energy and Water Development
Publisher:
ISBN:
Category : Energy development
Languages : en
Pages : 2032
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Book Description
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Energy and Water Development
Publisher:
ISBN:
Category : Energy development
Languages : en
Pages : 1890
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Book Description
Author: Chitram Lutchman
Publisher: CRC Press
ISBN: 1040074472
Category : Business & Economics
Languages : en
Pages : 344
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Book Description
Developing and maintaining a disciplined management system provides any organization with a blueprint for exceptional performance and success. Indeed, for larger multinational corporations, a management system is a critical component for sustainable growth and performance management. In this book, the authors discuss a series of fundamentals for cr
Author: Arthur James Wells
Publisher:
ISBN:
Category : Bibliography, National
Languages : en
Pages : 870
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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.
