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Improving The Regulatory Review Process Assessing Performance And Setting Targets
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Book Synopsis Improving the Regulatory Review Process: Assessing Performance and Setting Targets by : N. McAuslane
Download or read book Improving the Regulatory Review Process: Assessing Performance and Setting Targets written by N. McAuslane and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Safety Evaluation of Biotechnologically-derived Pharmaceuticals by : Susan A. Griffiths
Download or read book Safety Evaluation of Biotechnologically-derived Pharmaceuticals written by Susan A. Griffiths and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pharmaceutical Regulatory Environment by : Reem K. Al-Essa
Download or read book Pharmaceutical Regulatory Environment written by Reem K. Al-Essa and published by Springer. This book was released on 2015-05-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug Development and Safety written by and published by BoD – Books on Demand. This book was released on 2024-07-10 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Better Regulation by : Stephen Weatherill
Download or read book Better Regulation written by Stephen Weatherill and published by Bloomsbury Publishing. This book was released on 2007-06-28 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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".
Book Synopsis United States Code by : United States
Download or read book United States Code written by United States and published by . This book was released on 2013 with total page 1552 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The United States Code is the official codification of the general and permanent laws of the United States of America. The Code was first published in 1926, and a new edition of the code has been published every six years since 1934. The 2012 edition of the Code incorporates laws enacted through the One Hundred Twelfth Congress, Second Session, the last of which was signed by the President on January 15, 2013. It does not include laws of the One Hundred Thirteenth Congress, First Session, enacted between January 2, 2013, the date it convened, and January 15, 2013. By statutory authority this edition may be cited "U.S.C. 2012 ed." As adopted in 1926, the Code established prima facie the general and permanent laws of the United States. The underlying statutes reprinted in the Code remained in effect and controlled over the Code in case of any discrepancy. In 1947, Congress began enacting individual titles of the Code into positive law. When a title is enacted into positive law, the underlying statutes are repealed and the title then becomes legal evidence of the law. Currently, 26 of the 51 titles in the Code have been so enacted. These are identified in the table of titles near the beginning of each volume. The Law Revision Counsel of the House of Representatives continues to prepare legislation pursuant to 2 U.S.C. 285b to enact the remainder of the Code, on a title-by-title basis, into positive law. The 2012 edition of the Code was prepared and published under the supervision of Ralph V. Seep, Law Revision Counsel. Grateful acknowledgment is made of the contributions by all who helped in this work, particularly the staffs of the Office of the Law Revision Counsel and the Government Printing Office"--Preface.
Book Synopsis Management of Animal Care and Use Programs in Research, Education, and Testing by : Robert H. Weichbrod
Download or read book Management of Animal Care and Use Programs in Research, Education, and Testing written by Robert H. Weichbrod and published by CRC Press. This book was released on 2017-09-07 with total page 917 pages. Available in PDF, EPUB and Kindle. Book excerpt: AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).
Book Synopsis "Code of Massachusetts regulations, 1999" by :
Download or read book "Code of Massachusetts regulations, 1999" written by and published by . This book was released on 1999 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Book Synopsis "Code of Massachusetts regulations, 2005" by :
Download or read book "Code of Massachusetts regulations, 2005" written by and published by . This book was released on 2006 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Book Synopsis "Code of Massachusetts regulations, 2004" by :
Download or read book "Code of Massachusetts regulations, 2004" written by and published by . This book was released on 2004 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Book Synopsis Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by : OECD
Download or read book Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Book Synopsis "Code of Massachusetts regulations, 2009" by :
Download or read book "Code of Massachusetts regulations, 2009" written by and published by . This book was released on 2010 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Book Synopsis "Code of Massachusetts regulations, 2008" by :
Download or read book "Code of Massachusetts regulations, 2008" written by and published by . This book was released on 2008 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Book Synopsis "Code of Massachusetts regulations, 2007" by :
Download or read book "Code of Massachusetts regulations, 2007" written by and published by . This book was released on 2007 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Book Synopsis "Code of Massachusetts regulations, 2003" by :
Download or read book "Code of Massachusetts regulations, 2003" written by and published by . This book was released on 2004 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Book Synopsis The British National Bibliography by : Arthur James Wells
Download or read book The British National Bibliography written by Arthur James Wells and published by . This book was released on 2007 with total page 870 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Congressional Record by : United States. Congress
Download or read book Congressional Record written by United States. Congress and published by . This book was released on 2017-08 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:
