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Author : Bruno Sepodes
Publisher : Frontiers Media SA
ISBN 13 : 283250390X
Total Pages : 270 pages
Book Rating : 4.8/5 (325 download)
Download or read book Insights in Regulatory Science: 2021 written by Bruno Sepodes and published by Frontiers Media SA. This book was released on 2022-11-04 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 926452892X
Total Pages : 301 pages
Book Rating : 4.2/5 (645 download)
Download or read book OECD Regulatory Policy Outlook 2021 written by OECD and published by OECD Publishing. This book was released on 2021-10-06 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: The COVID-19 pandemic has highlighted the crucial role regulation plays in the economy and society, but has also exposed gaps in domestic and international rule-making that have cost lives and money. The 2021 Regulatory Policy Outlook, the third in the series, maps country efforts to improve regulatory quality in line with the 2012 OECD Recommendation on Regulatory Policy and Governance, and shares good regulatory practices that can help close the gaps.
Author : Javed Ali
Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.1/5 (282 download)
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Author : Vandana B. Patravale
Publisher : CRC Press
ISBN 13 : 1498730787
Total Pages : 433 pages
Book Rating : 4.4/5 (987 download)
Download or read book Pharmaceutical Product Development written by Vandana B. Patravale and published by CRC Press. This book was released on 2016-05-25 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493575
Total Pages : pages
Book Rating : 4.4/5 (935 download)
Download or read book Regulatory Intelligence 101, Third Edition written by Gloria Hall and published by . This book was released on 2021-03-26 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Collectif
Publisher : OECD
ISBN 13 : 9264307044
Total Pages : 230 pages
Book Rating : 4.2/5 (643 download)
Download or read book OECD Regulatory Policy Outlook 2018 written by Collectif and published by OECD. This book was released on 2018-10-10 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations govern the everyday life of businesses and citizens, and are important tools of public policy. Regulating has never been easy, but the overwhelming pace of technological change and unprecedented interconnectedness of economies has made it a daunting task. The 2018 Regulatory Policy Outlook, the second in the series, maps country efforts to improve regulatory quality in line with the 2012 OECD Recommendation on Regulatory Policy and Governance, and shares good regulatory practices. It provides unique insights into the organisation and institutional settings in countries for designing, enforcing and revising regulations. It also highlights areas of the regulatory cycle that receive too little attention from policy makers. Finally, it identifies areas where countries can invest to improve the quality of laws and regulations and presents innovative approaches to better regulation.
Author : Benjamin van Rooij
Publisher : Beacon Press
ISBN 13 : 0807049093
Total Pages : 314 pages
Book Rating : 4.8/5 (7 download)
Download or read book The Behavioral Code written by Benjamin van Rooij and published by Beacon Press. This book was released on 2021-10-26 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: A 2022 PROSE Award finalist in Legal Studies and Criminology A 2022 American Bar Association Silver Gavel Award Finalist A Behavioral Scientist’s Notable Book of 2021 Freakonomics for the law—how applying behavioral science to the law can fundamentally change and explain misbehavior Why do most Americans wear seatbelts but continue to speed even though speeding fines are higher? Why could park rangers reduce theft by removing “no stealing” signs? Why was a man who stole 3 golf clubs sentenced to 25 years in prison? Some laws radically change behavior whereas others are consistently ignored and routinely broken. And yet we keep relying on harsh punishment against crime despite its continued failure. Professors Benjamin van Rooij and Adam Fine draw on decades of research to uncover the behavioral code: the root causes and hidden forces that drive human behavior and our responses to society’s laws. In doing so, they present the first accessible analysis of behavioral jurisprudence, which will fundamentally alter how we understand the connection between law and human behavior. The Behavioral Code offers a necessary and different approach to battling crime and injustice that is based in understanding the science of human misconduct—rather than relying on our instinctual drive to punish as a way to shape behavior. The book reveals the behavioral code’s hidden role through illustrative examples like: • The illusion of the US’s beloved tax refund • German walls that “pee back” at public urinators • The $1,000 monthly “good behavior” reward that reduced gun violence • Uber’s backdoor “Greyball” app that helped the company evade Seattle’s taxi regulators • A $2.3 billion legal settlement against Pfizer that revealed how whistleblower protections fail to reduce corporate malfeasance • A toxic organizational culture playing a core role in Volkswagen’s emissions cheating scandal • How Peter Thiel helped Hulk Hogan sue Gawker into oblivion Revelatory and counterintuitive, The Behavioral Code catalyzes the conversation about how the law can effectively improve human conduct and respond to some of our most pressing issues today, from police misconduct to corporate malfeasance.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309208955
Total Pages : 700 pages
Book Rating : 4.3/5 (92 download)
Download or read book The Future of Nursing written by Institute of Medicine and published by National Academies Press. This book was released on 2011-02-08 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Nursing explores how nurses' roles, responsibilities, and education should change significantly to meet the increased demand for care that will be created by health care reform and to advance improvements in America's increasingly complex health system. At more than 3 million in number, nurses make up the single largest segment of the health care work force. They also spend the greatest amount of time in delivering patient care as a profession. Nurses therefore have valuable insights and unique abilities to contribute as partners with other health care professionals in improving the quality and safety of care as envisioned in the Affordable Care Act (ACA) enacted this year. Nurses should be fully engaged with other health professionals and assume leadership roles in redesigning care in the United States. To ensure its members are well-prepared, the profession should institute residency training for nurses, increase the percentage of nurses who attain a bachelor's degree to 80 percent by 2020, and double the number who pursue doctorates. Furthermore, regulatory and institutional obstacles-including limits on nurses' scope of practice-should be removed so that the health system can reap the full benefit of nurses' training, skills, and knowledge in patient care. In this book, the Institute of Medicine makes recommendations for an action-oriented blueprint for the future of nursing.
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264270485
Total Pages : 404 pages
Book Rating : 4.2/5 (642 download)
Download or read book Behavioural Insights and Public Policy Lessons from Around the World written by OECD and published by OECD Publishing. This book was released on 2017-03-01 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report discusses the use and reach of behavioural insights, drawing on a comprehensive collection of over 100 applications across the world and policy sectors.
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264503935
Total Pages : 37 pages
Book Rating : 4.2/5 (645 download)
Download or read book Data-Driven, Information-Enabled Regulatory Delivery written by OECD and published by OECD Publishing. This book was released on 2021-09-25 with total page 37 pages. Available in PDF, EPUB and Kindle. Book excerpt: Industries and businesses are becoming increasingly digital, and the COVID-19 pandemic has further accelerated this trend. This report maps out several efforts undertaken jointly by the OECD and Italian regulators to develop and use artificial intelligence and machine learning tools in regulatory inspections and enforcement.
Author : Mette Due Theilade Thomsen
Publisher : Frontiers Media SA
ISBN 13 : 2832520596
Total Pages : 124 pages
Book Rating : 4.8/5 (325 download)
Download or read book Women in science - regulatory science 2021 written by Mette Due Theilade Thomsen and published by Frontiers Media SA. This book was released on 2023-04-12 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Raymond A. Huml
Publisher : Springer Nature
ISBN 13 : 3030786056
Total Pages : 418 pages
Book Rating : 4.0/5 (37 download)
Download or read book Rare Disease Drug Development written by Raymond A. Huml and published by Springer Nature. This book was released on 2021-11-08 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.
Author : David Mantus
Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.8/5 (418 download)
Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Author : Cass R. Sunstein
Publisher : Simon and Schuster
ISBN 13 : 1476726612
Total Pages : 272 pages
Book Rating : 4.4/5 (767 download)
Download or read book Simpler written by Cass R. Sunstein and published by Simon and Schuster. This book was released on 2013-04-09 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Simpler government arrived four years ago. It helped put money in your pocket. It saved hours of your time. It improved your children’s diet, lengthened your life span, and benefited businesses large and small. It did so by issuing fewer regulations, by insisting on smarter regulations, and by eliminating or improving old regulations. Cass R. Sunstein, as administrator of the most powerful White House office you’ve never heard of, oversaw it and explains how it works, why government will never be the same again (thank goodness), and what must happen in the future. Cutting-edge research in behavioral economics has influenced business and politics. Long at the forefront of that research, Sunstein, for three years President Obama’s “regulatory czar” heading the White House Office of Information and Regulatory Affairs, oversaw a far-reaching restructuring of America’s regulatory state. In this highly anticipated book, Sunstein pulls back the curtain to show what was done, why Americans are better off as a result, and what the future has in store. The evidence is all around you, and more is coming soon. Simplified mortgages and student loan applications. Scorecards for colleges and universities. Improved labeling of food and energy-efficient appliances and cars. Calories printed on chain restaurant menus. Healthier food in public schools. Backed by historic executive orders ensuring transparency and accountability, simpler government can be found in new initiatives that save money and time, improve health, and lengthen lives. Simpler: The Future of Government will transform what you think government can and should accomplish.
Author : Jorge S. Burns
Publisher : Springer Nature
ISBN 13 : 3031300408
Total Pages : 226 pages
Book Rating : 4.0/5 (313 download)
Download or read book Potency Assays for Advanced Stem Cell Therapy Medicinal Products written by Jorge S. Burns and published by Springer Nature. This book was released on 2023-05-31 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various challenges raised are being managed. Stakeholders concerned with potency assay development range from patient and clinician to contract research organisations, small and medium enterprise, regulatory authorities and even politicians. The value of potency assays is poised to increase given the inevitable watershed as early-stage clinical trials addressing safety progress to trials testing efficacy. Contributors from clinical, academic, industrial and regulatory sectors establish a broad point of view for guidance and timely debate. Potency assays require extensive collaboration across disciplines and sectors, as well as compromise and the authors aim to constructively address the many key aspects involved. Potency assays provide a quantitative measure of the biological activity of advanced therapy medicinal products (ATMPs) and thus are required for their market authorization. As the pace of ATMP development accelerates, the need to develop specific, accurate, and robust potency assays for each product is also accelerating. The volume Potency Assays for Stem Cell Advanced Therapy Medicinal Products presents a broad outlook on the development, quality attributes, and implementation of potency assays for ATMPs. The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potency assay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval. Subsequent chapters highlight efforts to develop potency assays for specific ATMPs, including skeletal stem cells, mesenchymal stromal cells, extracellular vesicles, CAR T-cells, and discuss emerging technologies/platforms for potency assay design. The volume concludes with a chapter reviewing potency assays used for the release of commercial ATMP products, which amalgamates information contained in previous chapters. Overall, the knowledge contributed from leading authorities in both academia and industry is an ideal resource for technicians, scientists, clinicians, process engineers, and regulators working with ATMPs. —Donald G. Phinney, PhD Professor, Department of Molecular Medicine, Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 926416717X
Total Pages : 88 pages
Book Rating : 4.2/5 (641 download)
Download or read book Measuring Regulatory Performance A Practitioner's Guide to Perception Surveys written by OECD and published by OECD Publishing. This book was released on 2012-01-16 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide helps officials use perception surveys for evaluating and communicating progress in regulatory reform. It explains the challenges involved in the design and use of business and citizen perception surveys – and ways to overcome them.
Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493513
Total Pages : pages
Book Rating : 4.4/5 (935 download)
Download or read book Fundamentals of Pharmaceutical and Biologics Regulations, Third Edition written by Gloria Hall and published by . This book was released on 2020-07-29 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
