Proceedings and Recommendations of the Quality and Regulatory Review Committee

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Publisher :
ISBN 13 :
Total Pages : 41 pages
Book Rating : 4.:/5 (272 download)

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Book Synopsis Proceedings and Recommendations of the Quality and Regulatory Review Committee by : New York (State). Governor's Health Care Advisory Board. Quality and Regulatory Review Committee

Download or read book Proceedings and Recommendations of the Quality and Regulatory Review Committee written by New York (State). Governor's Health Care Advisory Board. Quality and Regulatory Review Committee and published by . This book was released on 1992 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt:

PROCEEDINGS AND RECOMMENDATIONS OF THE QUALITY AND REGULATORY REVIEW COMMITTEE: INTERIM REPORT 1991-92

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Publisher :
ISBN 13 :
Total Pages : 50 pages
Book Rating : 4.:/5 (131 download)

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Book Synopsis PROCEEDINGS AND RECOMMENDATIONS OF THE QUALITY AND REGULATORY REVIEW COMMITTEE: INTERIM REPORT 1991-92 by : NEW YORK. GOVERNOR'S HEALTH CARE ADVISORY BOARD.

Download or read book PROCEEDINGS AND RECOMMENDATIONS OF THE QUALITY AND REGULATORY REVIEW COMMITTEE: INTERIM REPORT 1991-92 written by NEW YORK. GOVERNOR'S HEALTH CARE ADVISORY BOARD. and published by . This book was released on 1992 with total page 50 pages. Available in PDF, EPUB and Kindle. Book excerpt:

52 Experiments with Regulatory Review: The Political and Economic Inputs Into State Rulemakings

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Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)

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Book Synopsis 52 Experiments with Regulatory Review: The Political and Economic Inputs Into State Rulemakings by : Jason A Schwartz

Download or read book 52 Experiments with Regulatory Review: The Political and Economic Inputs Into State Rulemakings written by Jason A Schwartz and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Improving the Regulatory Review Process

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Publisher : Springer Science & Business Media
ISBN 13 : 9400917880
Total Pages : 182 pages
Book Rating : 4.4/5 (9 download)

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Book Synopsis Improving the Regulatory Review Process by : C. Lumley

Download or read book Improving the Regulatory Review Process written by C. Lumley and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.

Improving the Regulatory Review Process: Assessing Performance and Setting Targets

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Publisher : Springer Science & Business Media
ISBN 13 : 9401148740
Total Pages : 174 pages
Book Rating : 4.4/5 (11 download)

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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.

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making

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Publisher : National Academies Press
ISBN 13 : 0309172802
Total Pages : 88 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by : Institute of Medicine

Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Ethical Conduct of Clinical Research Involving Children

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Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Small Business Advocacy Review Panels

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ISBN 13 :
Total Pages : 88 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Small Business Advocacy Review Panels by : United States. Congress. House. Committee on Small Business. Subcommittee on Regulatory Reform and Paperwork Reduction

Download or read book Small Business Advocacy Review Panels written by United States. Congress. House. Committee on Small Business. Subcommittee on Regulatory Reform and Paperwork Reduction and published by . This book was released on 1999 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Improving information quality in the federal government

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ISBN 13 :
Total Pages : 112 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Improving information quality in the federal government by : United States. Congress. House. Committee on Government Reform. Subcommittee on Regulatory Affairs

Download or read book Improving information quality in the federal government written by United States. Congress. House. Committee on Government Reform. Subcommittee on Regulatory Affairs and published by . This book was released on 2006 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Government Auditing Standards - 2018 Revision

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Publisher : Lulu.com
ISBN 13 : 0359536395
Total Pages : 234 pages
Book Rating : 4.3/5 (595 download)

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Book Synopsis Government Auditing Standards - 2018 Revision by : United States Government Accountability Office

Download or read book Government Auditing Standards - 2018 Revision written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Audits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.

Regulatory Improvement Act of 1999

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ISBN 13 :
Total Pages : 102 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis Regulatory Improvement Act of 1999 by : United States. Congress. Senate. Committee on Governmental Affairs

Download or read book Regulatory Improvement Act of 1999 written by United States. Congress. Senate. Committee on Governmental Affairs and published by . This book was released on 1999 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Food and Drug Administration Advisory Committees

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Publisher : National Academies Press
ISBN 13 : 0309048370
Total Pages : 239 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Food and Drug Administration Advisory Committees by : Institute of Medicine

Download or read book Food and Drug Administration Advisory Committees written by Institute of Medicine and published by National Academies Press. This book was released on 1992-02-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.

Improving the Quality of Care in Nursing Homes

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Publisher : National Academies Press
ISBN 13 : 0309036461
Total Pages : 432 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Improving the Quality of Care in Nursing Homes by : Institute of Medicine

Download or read book Improving the Quality of Care in Nursing Homes written by Institute of Medicine and published by National Academies Press. This book was released on 1986-02-01 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: As more people live longer, the need for quality long-term care for the elderly will increase dramatically. This volume examines the current system of nursing home regulations, and proposes an overhaul to better provide for those confined to such facilities. It determines the need for regulations, and concludes that the present regulatory system is inadequate, stating that what is needed is not more regulation, but better regulation. This long-anticipated study provides a wealth of useful background information, in-depth study, and discussion for nursing home administrators, students, and teachers in the health care field; professionals involved in caring for the elderly; and geriatric specialists.

Regulatory Accountability Act of 2011

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Publisher :
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4.:/5 (318 download)

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Book Synopsis Regulatory Accountability Act of 2011 by : United States. Congress. House. Committee on the Judiciary

Download or read book Regulatory Accountability Act of 2011 written by United States. Congress. House. Committee on the Judiciary and published by . This book was released on 2012 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:

A Checklist of Official Publications of the State of New York

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Publisher :
ISBN 13 :
Total Pages : 380 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis A Checklist of Official Publications of the State of New York by : New York State Library

Download or read book A Checklist of Official Publications of the State of New York written by New York State Library and published by . This book was released on 1993 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:

OECD Reviews of Regulatory Reform

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Publisher : OECD Publishing
ISBN 13 :
Total Pages : 324 pages
Book Rating : 4./5 ( download)

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Book Synopsis OECD Reviews of Regulatory Reform by :

Download or read book OECD Reviews of Regulatory Reform written by and published by OECD Publishing. This book was released on 1999 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Standards for Internal Control in the Federal Government

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Publisher : Lulu.com
ISBN 13 : 0359541828
Total Pages : 88 pages
Book Rating : 4.3/5 (595 download)

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Book Synopsis Standards for Internal Control in the Federal Government by : United States Government Accountability Office

Download or read book Standards for Internal Control in the Federal Government written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers? Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.