Improving The Regulatory Review Process Assessing Performance And Setting Targets
DOWNLOAD
Download Improving The Regulatory Review Process Assessing Performance And Setting Targets PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Improving The Regulatory Review Process Assessing Performance And Setting Targets book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Improving The Regulatory Review Process Assessing Performance And Setting Targets
DOWNLOAD
Author : N. McAuslane
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Improving The Regulatory Review Process Assessing Performance And Setting Targets written by N. McAuslane and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
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.
Improving The Regulatory Review Process Assessing Performance And Setting Targets
DOWNLOAD
Author : J. A. Neil McAuslane
language : en
Publisher: Springer Science & Business Media
Release Date : 1997
Improving The Regulatory Review Process Assessing Performance And Setting Targets written by J. A. Neil McAuslane and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Medical categories.
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 sugges
Safety Evaluation Of Biotechnologically Derived Pharmaceuticals
DOWNLOAD
Author : Susan A. Griffiths
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Safety Evaluation Of Biotechnologically Derived Pharmaceuticals written by Susan A. Griffiths and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
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.
The Regulation Of Medical Products
DOWNLOAD
Author : Penny Gleeson
language : en
Publisher: Taylor & Francis
Release Date : 2024-12-31
The Regulation Of Medical Products written by Penny Gleeson and has been published by Taylor & Francis this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-12-31 with Law categories.
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.
Pharmaceutical Regulatory Environment
DOWNLOAD
Author : Reem K. Al-Essa
language : en
Publisher: Springer
Release Date : 2015-05-06
Pharmaceutical Regulatory Environment written by Reem K. Al-Essa and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-05-06 with Medical categories.
This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.
Department Of The Interior And Related Agencies Appropriations For 2002
DOWNLOAD
Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Department of the Interior and Related Agencies
language : en
Publisher:
Release Date : 2001
Department Of The Interior And Related Agencies Appropriations For 2002 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Department of the Interior and Related Agencies and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with United States categories.
Federal Register
DOWNLOAD
Author :
language : en
Publisher:
Release Date : 2013-03
Federal Register written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03 with Delegated legislation categories.
Using Data To Improve Student Learning
DOWNLOAD
Author : Graham S. Maxwell
language : en
Publisher: Springer Nature
Release Date : 2021-04-21
Using Data To Improve Student Learning written by Graham S. Maxwell and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-21 with Education categories.
This book offers a coherent research-based overview and analysis of theories and practices in using data to improve student learning. It clarifies what 'use of data' means and differentiates the different levels of decision-making in education (relating to the system, district, school, classroom, or individual student). The relationship between data and decision-making is considered and various movements in the use of data to improve student learning are analysed, especially from the perspective of their assumptions and effects. This leads to a focus on effective educational decision-making as a social process requiring collaboration among all relevant participants. It also requires a clear understanding of educational aims, and these are seen to transcend what can be assessed by standardised tests. The consequences of this analysis for decision processes are explored and conclusions are drawn about what principles might best guide educational practice as well as what ambiguities remain. Throughout, the focus is on what existing research says about each of the issues explored.
Leading Issues In Competition Regulation And Development
DOWNLOAD
Author : Paul Cook
language : en
Publisher: Edward Elgar Publishing
Release Date : 2004-01-01
Leading Issues In Competition Regulation And Development written by Paul Cook and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-01-01 with Business & Economics categories.
The promotion of liberalized and deregulated markets by bilateral and multilateral aid donors, and by global institutions such as the WTO, has led to significant attention being paid to competition and regulatory reforms in developing economies. The process of reform involves the transfer and diffusion of market models derived from practice and theory in developed countries. However, in developing countries, regulation needs to do more than simply promote competitiveness and consumer interests: it also needs to ensure that the market nurtures development. By rigorously examining the numerous impacts of regulation, this book will help to fill a significant gap in the literature on economic and social development. The book, now available in paperback, draws together contributions from leading experts across a range of disciplines including economics, law, politics and governance, public management and business management. The authors begin with an extensive overview of the issues of regulation and competition in developing countries, and carefully illustrate the important themes and concepts involved. Using a variety of country and sector case studies, they move on to focus on the problems of applicability and adaptation that are experienced in the process of transferring best practice policy models from developed to developing countries. The book presents a clear agenda for further empirical research and is notable for its rigorous exploration of the links between theory and practice. Although there is substantial interest in competition and regulation, as yet there has been relatively little investigation of these issues in developing economies. This book redresses the balance and will be a valuable resource for researchers, academics, teachers and students interested in development economics and development studies. It will also be of great relevance for practitioners and policymakers working in the fields of competition policy and regulatory reform.
Solar Ponds
DOWNLOAD
Author : Ibrahim Dincer
language : en
Publisher: Springer Nature
Release Date : 2023-12-12
Solar Ponds written by Ibrahim Dincer and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-12 with Technology & Engineering categories.
This book is about solar ponds for energy storage from various perspectives, including fundamentals, efficiencies, system designs, local applications and details about what have been done in the world in the field of solar ponds for generating energy and storage it for useful purposes.