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Research Regulatory Compliance

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Research Regulatory Compliance

Research Regulatory Compliance Book
Author : Mark A. Suckow,Bill Yates
Publisher : Academic Press
Release : 2015-06-14
ISBN : 0124200656
Language : En, Es, Fr & De

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Book Description :

Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. Provides a “one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment Focuses on United States regulations, covering both animal models and human subjects Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Clinical Trials and Human Research

Clinical Trials and Human Research Book
Author : Fay A. Rozovsky, JD, MPH,Rodney K. Adams
Publisher : Jossey-Bass
Release : 2003-06-10
ISBN : 9780787965709
Language : En, Es, Fr & De

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Book Description :

This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children Book
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Release : 2004-07-09
ISBN : 9780309133388
Language : En, Es, Fr & De

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Book Description :

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.

Research Ethics and Integrity for Social Scientists

Research Ethics and Integrity for Social Scientists Book
Author : Mark Israel
Publisher : SAGE
Release : 2014-10-20
ISBN : 1473909163
Language : En, Es, Fr & De

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Book Description :

Ethics and integrity in research are increasingly important for social scientists around the world. We are tackling more complex problems in the face of expanding and not always sympathetic regulation. This book surveys the recent developments and debates around researching ethically and with integrity and complying with ethical requirements. The new edition pushes beyond the work of the first edition through updated and extended coverage of issues relating to international, indigenous, interdisciplinary and internet research. Through case studies and examples drawn from all continents and from across the social science disciplines, the book: demonstrates the practical value of thinking seriously and systematically about ethical conduct in social science research identifies how and why current regulatory regimes have emerged reveals those practices that have contributed to the adversarial relationships between researchers and regulators encourages all parties to develop shared solutions to ethical and regulatory problems.

Optimizing the Nation s Investment in Academic Research

Optimizing the Nation s Investment in Academic Research Book
Author : National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century
Publisher : National Academies Press
Release : 2016-06-29
ISBN : 0309379512
Language : En, Es, Fr & De

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Book Description :

Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

Management of Animal Care and Use Programs in Research Education and Testing

Management of Animal Care and Use Programs in Research  Education  and Testing Book
Author : Robert H. Weichbrod,Gail A. (Heidbrink) Thompson,John N. Norton
Publisher : CRC Press
Release : 2017-09-07
ISBN : 1498748457
Language : En, Es, Fr & De

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Book Description :

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).

Ethical and Regulatory Aspects of Clinical Research

Ethical and Regulatory Aspects of Clinical Research Book
Author : Ezekiel J. Emanuel,Robert A. Crouch,Christine Grady,John D. Arras,Jonathan D. Moreno
Publisher : Unknown
Release : 2003
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Professionals in need of such training and bioethicists will be interested.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Book
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release : 2012-04-04
ISBN : 0309222176
Language : En, Es, Fr & De

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Book Description :

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Book
Author : John Geigert
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 144199131X
Language : En, Es, Fr & De

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Book Description :

"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.

Research Ethics for Social Scientists

Research Ethics for Social Scientists Book
Author : Mark Israel,Iain Hay
Publisher : SAGE
Release : 2006-06-29
ISBN : 9781412903905
Language : En, Es, Fr & De

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Book Description :

Introduces students to ethical theory and philosophy. This work provides practical guidance on what ethical theory means for research practice; and, offers case studies to give real examples of ethics in research action.

The Regulatory Compliance Almanac

The Regulatory Compliance Almanac Book
Author : Les Schnoll
Publisher : Paton Professional
Release : 2008
ISBN : 9781932828191
Language : En, Es, Fr & De

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Book Description :

Download The Regulatory Compliance Almanac book written by Les Schnoll, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Implementing Human Research Regulations

Implementing Human Research Regulations Book
Author : Anonim
Publisher : Unknown
Release : 1983
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Implementing Human Research Regulations book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Medical Device Quality Assurance and Regulatory Compliance

Medical Device Quality Assurance and Regulatory Compliance Book
Author : Richard C. Fries
Publisher : CRC Press
Release : 1998-08-11
ISBN : 9780824701772
Language : En, Es, Fr & De

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Book Description :

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

The Fundamentals of Clinical Research

The Fundamentals of Clinical Research Book
Author : P. Michael Dubinsky,Karen A. Henry
Publisher : John Wiley & Sons
Release : 2022-01-26
ISBN : 1118949595
Language : En, Es, Fr & De

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Book Description :

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

The Regulatory Environment for Science

The Regulatory Environment for Science Book
Author : Anonim
Publisher : Unknown
Release : 1986
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Regulatory Environment for Science book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

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

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Book
Author : Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publisher : National Academies Press
Release : 1999-07-27
ISBN : 9780309172806
Language : En, Es, Fr & De

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Book Description :

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.

The Regulatory environment for science

The Regulatory environment for science  Book
Author : Anonim
Publisher : DIANE Publishing
Release : 2023-02-06
ISBN : 1428923136
Language : En, Es, Fr & De

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Book Description :

Download The Regulatory environment for science book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States Book
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release : 2010-10-22
ISBN : 9780309163354
Language : En, Es, Fr & De

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Book Description :

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Research Ethics and Integrity for Social Scientists

Research Ethics and Integrity for Social Scientists Book
Author : Mark Israel
Publisher : SAGE Publications Limited
Release : 2014-10-20
ISBN : 9781446207499
Language : En, Es, Fr & De

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Book Description :

Ethics and integrity in research are increasingly important for social scientists around the world. We are tackling more complex problems in the face of expanding and not always sympathetic regulation. This book surveys the recent developments and debates around researching ethically and with integrity and complying with ethical requirements. The new edition pushes beyond the work of the first edition through updated and extended coverage of issues relating to international, indigenous, interdisciplinary and internet research. Through case studies and examples drawn from all continents and from across the social science disciplines, the book: demonstrates the practical value of thinking seriously and systematically about ethical conduct in social science research identifies how and why current regulatory regimes have emerged reveals those practices that have contributed to the adversarial relationships between researchers and regulators encourages all parties to develop shared solutions to ethical and regulatory problems.

Explaining Compliance

Explaining Compliance Book
Author : Christine Parker,Vibeke Lehmann Nielsen
Publisher : Edward Elgar Publishing
Release : 2011
ISBN : 0857938738
Language : En, Es, Fr & De

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Book Description :

'Taking a broad view of regulation, and covering a wide range of issues and industries, this collection is the most innovative effort to date to understand the responses of business firms to regulation. The book brings together an impressive group of scholars who analyze the concept of compliance and offer theoretically informed studies of its assumed links to regulation. A must read for both academics and practitioners, this ground-breaking collection firmly establishes a scholarly field of compliance studies.' Ronen Shamir, Tel Aviv University, Israel 'Business responses to regulation is a key area of social science research. Parker and Nielsen's collection brings together an excellent group of scholars with innovative, and I believe highly influential contributions that problematize the relations between regulation and compliance. The collection is a highly welcome addition to our field, that will redefine the research agenda on compliance. A significant achievement that will help to improve policy making and frame the scholarly research agenda for the years to come.' David Levi-Faur, The Hebrew University of Jerusalem, Israel and the Free University of Berlin, Germany 'A timely and important set of analyses on how and why businesses respond to regulation in the way that they do from some of the leading authors in the field, covering business responses to both state and non-state regulatory systems.' Julia Black, London School of Economics, UK Explaining Compliance consists of sixteen specially commissioned chapters by the world's leading empirical researchers, examining whether and how businesses comply with regulation that is designed to affect positive behaviour changes. Each chapter consists of reflective summaries on business compliance with different state or voluntary regulation, and the theoretical lessons to be drawn from it. As a whole, the book develops understanding and explanations of how, why and in what circumstances, firms come to comply with regulation, and when they do not. It also uncovers the complexity, ambiguity and transformation of regulation as it is interpreted, implemented and negotiated by firms, their stakeholders and internal constituencies in everyday business life. This unique and detailed resource will appeal to academics, graduate students and senior undergraduates in law, political science, sociology, criminology, economics, and psychology, as well as business and interdisciplinary areas such as law and society, and law and economics. Anyone researching business regulation, corporate social responsibility, regulation and compliance, enforcement and compliance, and public administration, will also find this book beneficial.