Global Regulations And Inspections Research Quality Assurance

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Global Clinical Trials Playbook

Author : Menghis Bairu
Publisher : Academic Press
ISBN 13 : 0124157874
Total Pages : 332 pages
Book Rating : 4.1/5 (241 download)

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Book Synopsis Global Clinical Trials Playbook by : Menghis Bairu

Download or read book Global Clinical Trials Playbook written by Menghis Bairu and published by Academic Press. This book was released on 2012-04-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

The Federal Role in International Testing, Certification, and Quality Assurance

Author : United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Science, Research, and Technology
Publisher :
ISBN 13 :
Total Pages : 220 pages
Book Rating : 4.0/5 (18 download)

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Book Synopsis The Federal Role in International Testing, Certification, and Quality Assurance by : United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Science, Research, and Technology

Download or read book The Federal Role in International Testing, Certification, and Quality Assurance written by United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Science, Research, and Technology and published by . This book was released on 1990 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Quality Assurance Management

Author : Gayathri De Lanerolle
Publisher : Academic Press
ISBN 13 : 0128227338
Total Pages : 336 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Quality Assurance Management by : Gayathri De Lanerolle

Download or read book Quality Assurance Management written by Gayathri De Lanerolle and published by Academic Press. This book was released on 2024-07-20 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating procedures (SOPs) to ensure protocol and regulation adherence. The book showcases similarities and differences between healthcare and academic quality assurance systems, resulting in counter-productivity and performance issues, in addition to regulatory inspection preparedness. It uses the processes and standards of the UK to demonstrate how to combine QA and research building into 'building blocks' that share a common pathway for effective project design, analysis and unbiased interpretation of collated data.This book fills a gap, providing original research in QA that especially focuses on specialist areas. It will be of use to research and clinical staff working in clinical research within healthcare, academia and industry. - Uses practice-based evidence for developing and delivering quality assurance and management systems - Includes case studies associated with 'failures' and 'lessons learned' - Discusses clinical trials in academic, clinical and industry settings - Demonstrates how to build resilience into systems that could evolve to promote best practices, even with limited resources - Compares and contrasts different QA/QC practices

Quality Control and Regulatory Aspects for Biologicals

Author : Gauri Misra
Publisher : CRC Press
ISBN 13 : 1040004369
Total Pages : 209 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Quality Control and Regulatory Aspects for Biologicals by : Gauri Misra

Download or read book Quality Control and Regulatory Aspects for Biologicals written by Gauri Misra and published by CRC Press. This book was released on 2024-04-22 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management. It delves into the advantages and limitations of in vivo tests and discusses alternative methods that can be employed. The book explores the use of animal-based testing methods in quality control and examines viable alternatives. Key Features: Reviews various scientific and regulatory aspects involved in the quality control of biologicals Provides an overview of the roles of various national and international regulatory bodies and accreditation agencies Presents advanced analytical methods, innovative technologies, and the integration of molecular diagnostics in quality control processes Explores the use of animal-based testing methods in quality control, as well as their alternatives Discusses guidelines and methodologies involved in the development of biological products Overall, this book is an important reference source for various professionals in the pharmaceutical industry, including researchers, scientists, quality control personnel, and regulatory affairs professionals.

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

Author : Pierre-Louis Lezotre
Publisher : Academic Press
ISBN 13 : 0128005696
Total Pages : 377 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations by : Pierre-Louis Lezotre

Download or read book International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations written by Pierre-Louis Lezotre and published by Academic Press. This book was released on 2013-12-05 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area

The Routledge Companion to Auditing

Author : David Hay
Publisher : Routledge
ISBN 13 : 1136210350
Total Pages : 387 pages
Book Rating : 4.1/5 (362 download)

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Book Synopsis The Routledge Companion to Auditing by : David Hay

Download or read book The Routledge Companion to Auditing written by David Hay and published by Routledge. This book was released on 2014-09-15 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Auditing has been a subject of some controversy, and there have been repeated attempts at reforming its practice globally. This comprehensive companion surveys the state of the discipline, including emerging and cutting-edge trends. It covers the most important and controversial issues, including auditing ethics, auditor independence, social and environmental accounting as well as the future of the field. This handbook is vital reading for legislators, regulators, professionals, commentators, students and researchers involved with auditing and accounting. The collection will also prove an ideal starting place for researchers from other fields looking to break into this vital subject.

Publications of the National Institute of Standards and Technology ... Catalog

Author : National Institute of Standards and Technology (U.S.)
Publisher :
ISBN 13 :
Total Pages : 1162 pages
Book Rating : 4.3/5 (243 download)

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Book Synopsis Publications of the National Institute of Standards and Technology ... Catalog by : National Institute of Standards and Technology (U.S.)

Download or read book Publications of the National Institute of Standards and Technology ... Catalog written by National Institute of Standards and Technology (U.S.) and published by . This book was released on 1994 with total page 1162 pages. Available in PDF, EPUB and Kindle. Book excerpt:

PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II

Author : Dr. Trilochan Satapathy
Publisher : JEC PUBLICATION
ISBN 13 : 9361759019
Total Pages : 244 pages
Book Rating : 4.3/5 (617 download)

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Book Synopsis PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II by : Dr. Trilochan Satapathy

Download or read book PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II written by Dr. Trilochan Satapathy and published by JEC PUBLICATION. This book was released on with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete handbook on toxicology covers basic principles, regulatory criteria, and sophisticated methods for understanding and assuring the safety of varied chemicals in the following pages. Introduction to toxicology, "Toxicology Fundamentals and Regulatory Guidelines," covers broad overviews, mechanistic toxicology, regulatory frameworks, and descriptive toxicology. Focus is on OECD, ICH, EPA, and Schedule Y regulatory criteria, as well as the history and importance of Good Laboratory Practise (GLP) in drug development. As the book explores "Types of Toxicity Studies and Test Item Characterization," it examines acute, sub-acute, chronic, and particular acute investigations, including oral, cutaneous, and inhalational toxicity studies. Test item characterisation procedures are carefully explained, emphasising their importance in regulatory compliance and toxicity evaluation. This leads to "Advanced Toxicology Studies," which covers reproductive toxicology, genotoxicity, and in vivo carcinogenicity. These investigations provide a thorough view of possible dangers and evaluate drug safety. The book then discusses "IND Enabling Studies and Safety Pharmacology," which covers the necessary research for IND applications. Exploring regulatory settings, corporate views, and safety pharmacology in drug development provides a complete knowledge of experimental substance safety. The third part, "Toxicokinetic and Alternatives to Animal Testing," emphasises toxicokinetic assessment and discusses new methods. Following the evolution of safety assessment practises, these options are investigated for ethical and regulatory consequences. Students, researchers, and professionals traversing toxicology's difficult landscape may find this book invaluable. Its extensive coverage, from basic concepts to sophisticated approaches, makes it an important tool for protecting humans and ecosystems in the dynamic pharmaceuticals and beyond industries.

Energy Research Abstracts

Author :
Publisher :
ISBN 13 :
Total Pages : 354 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis Energy Research Abstracts by :

Download or read book Energy Research Abstracts written by and published by . This book was released on 1993 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Regulated Bioanalytical Laboratories

Author : Michael Zhou
Publisher : John Wiley & Sons
ISBN 13 : 0470476591
Total Pages : 564 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Regulated Bioanalytical Laboratories by : Michael Zhou

Download or read book Regulated Bioanalytical Laboratories written by Michael Zhou and published by John Wiley & Sons. This book was released on 2011-02-22 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.

Handbook of Pharmaceutical Manufacturing Formulations

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420048457
Total Pages : 258 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Pharmaceutical Manufacturing Formulations by : Sarfaraz K. Niazi

Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2004-04-27 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul

Routledge International Handbook of Outdoor Studies

Author : Barbara Humberstone
Publisher : Routledge
ISBN 13 : 1317666518
Total Pages : 1134 pages
Book Rating : 4.3/5 (176 download)

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Book Synopsis Routledge International Handbook of Outdoor Studies by : Barbara Humberstone

Download or read book Routledge International Handbook of Outdoor Studies written by Barbara Humberstone and published by Routledge. This book was released on 2015-11-19 with total page 1134 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ‘outdoors’ is a physical and ideological space in which people engage with their environment, but it is also an important vehicle for learning and for leisure. The Routledge Handbook of Outdoor Studies is the first book to attempt to define and survey the multi-disciplinary set of approaches that constitute the broad field of outdoor studies, including outdoor recreation, outdoor education, adventure education, environmental studies, physical culture studies and leisure studies. It reflects upon the often haphazard development of outdoor studies as a discipline, critically assesses current knowledge in outdoor studies, and identifies further opportunities for future research in this area. With a broader sweep than any other book yet published on the topic, this handbook traces the philosophical and conceptual contours of the discipline, as well as exploring key contemporary topics and debates, and identifying important issues in education and professional practice. It examines the cultural, social and political contexts in which people experience the outdoors, including perspectives on outdoor studies from a wide range of countries, providing the perfect foundation for any student, researcher, educator or outdoors practitioner looking to deepen their professional knowledge of the outdoors and our engagement with the world around us.

Handbook of Quality Assurance for University Teaching

Author : Roger Ellis
Publisher : Routledge
ISBN 13 : 1351740326
Total Pages : 522 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Handbook of Quality Assurance for University Teaching by : Roger Ellis

Download or read book Handbook of Quality Assurance for University Teaching written by Roger Ellis and published by Routledge. This book was released on 2018-07-03 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical and authoritative handbook provides a comprehensive overview of the issues and approaches to assuring quality in university teaching. Including contributions from major international figures, the book contains a wealth of ideas and practical advice to help universities commit to quality in teaching and offers insights into how the topics raised can be directly applied. The book initially identifies some of the key issues surrounding the topic, such as the evidence-based identification of teaching quality; the training of university lecturers and faculty; external and internal quality assurance; the tension between professional autonomy and governmental regulation; and the involvement of students in developing quality. It then moves on to present ideas and initiatives to address these problems, tackling the subject through four sections: Assuring Quality – questioning what quality assurance means and how it might be practised; Identifying Quality – examining what knowledge exists at present and how it might be further researched; Developing Quality – investigating the development of staff through teacher training and appraisal; Case Studies of Quality Assurance – reviewing six case studies of quality assurance in a range of contrasting subjects including the professional subjects of Medicine, Nursing and Teacher Training which are also addressed systemically in the first section. Full of practical advice, Handbook of Quality Assurance for University Teaching is an invaluable and unique resource for Faculty, Subject Leaders, University Administrators and Quality Assessors.

ERDA Energy Research Abstracts

Author : United States. Energy Research and Development Administration
Publisher :
ISBN 13 :
Total Pages : 994 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis ERDA Energy Research Abstracts by : United States. Energy Research and Development Administration

Download or read book ERDA Energy Research Abstracts written by United States. Energy Research and Development Administration and published by . This book was released on 1977 with total page 994 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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

Author : Institute of Medicine
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.

Engineering and Managing Software Requirements

Author : Aybüke Aurum
Publisher : Springer Science & Business Media
ISBN 13 : 9783540250432
Total Pages : 504 pages
Book Rating : 4.2/5 (54 download)

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Book Synopsis Engineering and Managing Software Requirements by : Aybüke Aurum

Download or read book Engineering and Managing Software Requirements written by Aybüke Aurum and published by Springer Science & Business Media. This book was released on 2005-07-06 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following an introductory chapter that provides an exploration of key issues in requirements engineering, this book is organized in three parts. It presents surveys of requirements engineering process research along with critical assessments of existing models, frameworks and techniques. It also addresses key areas in requirements engineering.