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:
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
Download or read book Innovative Statistics in Regulatory Science written by Shein-Chung Chow and published by CRC Press. This book was released on 2019-11-14 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.
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.
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.
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 438 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
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 91 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.
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.
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:
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.
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.
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.
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 408 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.
Download or read book Targeted Regulatory Writing Techniques Clinical Documents for Drugs and Biologics written by Linda Fossati Wood and published by Springer Science & Business Media. This book was released on 2009-01-05 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
Download or read book Legislation and Regulation written by John Manning and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The updated casebook, Manning and Stephenson's Legislation and Regulation, 2d, is designed for a first-year class on Legislation & Regulation, and provides a proven, ready-to-use set of materials for those interested in introducing such a class to their 1L curriculum. The book focuses on the tools and methods of interpreting legal texts, using Supreme Court and other appellate decisions as the primary texts, yet the note material gently introduces students to applicable insights from political science, history, economics, and philosophy. The book aims to familiarize students with tools and techniques that lawyers and judges use when crafting legal arguments in statutory or regulatory contexts, and to give students a sense of the larger questions of institutional design implicated by these interpretive questions.
Download or read book Case Studies in Innovative Clinical Trials written by Kristine Broglio and published by CRC Press. This book was released on 2023-11-27 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design. Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies. Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered. A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own.
Download or read book Powering the Digital Economy Opportunities and Risks of Artificial Intelligence in Finance written by El Bachir Boukherouaa and published by International Monetary Fund. This book was released on 2021-10-22 with total page 35 pages. Available in PDF, EPUB and Kindle. Book excerpt: This paper discusses the impact of the rapid adoption of artificial intelligence (AI) and machine learning (ML) in the financial sector. It highlights the benefits these technologies bring in terms of financial deepening and efficiency, while raising concerns about its potential in widening the digital divide between advanced and developing economies. The paper advances the discussion on the impact of this technology by distilling and categorizing the unique risks that it could pose to the integrity and stability of the financial system, policy challenges, and potential regulatory approaches. The evolving nature of this technology and its application in finance means that the full extent of its strengths and weaknesses is yet to be fully understood. Given the risk of unexpected pitfalls, countries will need to strengthen prudential oversight.
