Download or read book Law and the Regulation of Medicines written by Emily Jackson and published by Bloomsbury Publishing. This book was released on 2012-03-01 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.
Download or read book The Law and Regulation of Medicines and Medical Devices written by Peter Feldschreiber and published by . This book was released on 2021-10-04 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide for legal, medical, and pharmaceutical professionals, offering an authoritative and comprehensive source of expertise on the legislation and case law governing regulation of medicines and medical devices, and their liability under consumer protection law in the UK and EU.
Download or read book The Laws of Medicine written by Siddhartha Mukherjee and published by Simon and Schuster. This book was released on 2015-10-13 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essential, required reading for doctors and patients alike: A Pulitzer Prize-winning author and one of the world’s premiere cancer researchers reveals an urgent philosophy on the little-known principles that govern medicine—and how understanding these principles can empower us all. Over a decade ago, when Siddhartha Mukherjee was a young, exhausted, and isolated medical resident, he discovered a book that would forever change the way he understood the medical profession. The book, The Youngest Science, forced Dr. Mukherjee to ask himself an urgent, fundamental question: Is medicine a “science”? Sciences must have laws—statements of truth based on repeated experiments that describe some universal attribute of nature. But does medicine have laws like other sciences? Dr. Mukherjee has spent his career pondering this question—a question that would ultimately produce some of most serious thinking he would do around the tenets of his discipline—culminating in The Laws of Medicine. In this important treatise, he investigates the most perplexing and illuminating cases of his career that ultimately led him to identify the three key principles that govern medicine. Brimming with fascinating historical details and modern medical wonders, this important book is a fascinating glimpse into the struggles and Eureka! moments that people outside of the medical profession rarely see. Written with Dr. Mukherjee’s signature eloquence and passionate prose, The Laws of Medicine is a critical read, not just for those in the medical profession, but for everyone who is moved to better understand how their health and well-being is being treated. Ultimately, this book lays the groundwork for a new way of understanding medicine, now and into the future.
Download or read book Life Sciences Law written by Roseann B. Termini and published by Forti Publications. This book was released on 2007 with total page 808 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Law and Ethics of the Pharmaceutical Industry written by M.N.G. Dukes and published by Elsevier. This book was released on 2005-11-04 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book Dale and Appelbe s Pharmacy and Medicines Law written by Gordon E. Appelbe and published by Pharmaceutical Press. This book was released on 2013 with total page 609 pages. Available in PDF, EPUB and Kindle. Book excerpt: This tenth edition of Dale and Appelbe's Pharmacy and Medicines Law, previously Dale and Appelbe's Pharmacy Law and Ethics, is your definitive guide to law relating to pharmacy and medicine practice in Great Britain. It covers law and professional regulation that all pharmacy and medicine professionals need to know.
Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Download or read book Pharmaceutical Medicine written by Adrian Kilcoyne and published by OUP Oxford. This book was released on 2013-05-23 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Download or read book Pharmaceutical and Medical Device Law written by Michael E. Clark and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmacy Practice and The Law written by Richard Abood and published by Jones & Bartlett Learning. This book was released on 2011 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Sixth Edition of this best-selling text includes updates to account for new legal, regulatory and policy developments. Pharmacy Practice and the Law, Sixth Edition provides background, history and discussion of the law so as to enable the student to not only learn the facts, but to help them understand, apply and critically evaluate the information. The issues covered in this text are discussed in non-legal, easy to understand language. Challenging open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Citations to all laws, court cases, regulations and other documents are provided. An online instructor’s manual is available. Pharmacy Practice and the Law, Sixth Edition, is a useful resource both for teaching the facts of pharmacy law and for stimulating critical thinking issues in pharmacy law.
Download or read book Pharmacy Practice and the Law written by Richard R. Abood and published by Jones & Bartlett Publishers. This book was released on 2015-12-03 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: Burns joins Abood for this edition of a law textbook for teaching the facts of pharmacy law, the background underpinning those facts, and critical thinking in the field. They have revised it to account for changes in law and practice and to incorporate suggestions from instructors who have used previous editions. Their topics are the law and the legal system; federal regulation of medications: development, production, and marketing; federal regulation of medications: dispensing; the closed system of controlled substance distribution; dispensing controlled substances; federal regulation of pharmacy practice; state regulation of pharmacy practice; and pharmacist malpractice and liability and risk management strategies.
Download or read book Pharmacy Law and Practice written by Jon Merrills and published by Academic Press. This book was released on 2013-04-19 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacy Law and Practice, Fifth Edition provides a straightforward and useable guide for students, practitioners, academics and others interested in pharmacy law and practice in the United Kingdom. This multi-dimensional book includes discussions of socio-political influences on legal developments to provide greater insight to the reader. It clearly sets out the background to regulatory issues together with simple and practical statements of what a pharmacist has to do to obey the law. As in previous editions, this book discusses topics thematically rather than by statute. It is a unique and reader-friendly guide that boils down the complex or difficult language of the law, describes the reasons behind it, and illustrates the application to pharmacy practice. Thoroughly updated to reflect regulatory and legal developments in areas including employment law, online transactions and internet pharmacies, non-medical prescribing and more Takes an intuitive, problem-solving approach and discusses topics thematically rather than by statute to show how all of the larger pieces fit together The electronic version of this book contains valuable links to provide readers with the most current information in a rapidly changing subject area
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-03 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Download or read book The Law of Off label Uses of Medicines written by Andrea Parziale and published by Taylor & Francis. This book was released on 2022-08-12 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.
Download or read book Pharmacy Practice and the Law written by Richard R. Abood and published by Jones & Bartlett Publishers. This book was released on 2014 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Seventh Edition of this best-selling text includes updates to account for new legal, regulatory, and policy developments. Pharmacy Practice and the Law, Seventh Edition provides background, history, and discussion of the law to The Seventh Edition of this best-selling text includes updates to account for new legal, regulatory, and policy developments. Pharmacy Practice and the Law, Seventh Edition provides background, history, and discussion of the law to enable students not only to learn the facts, but to help them understand, apply, and critically evaluate the information and how it will affect their practice. Challenging open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Citations to all laws, court cases, regulations, and other documents are provided. Critical issues are discussed in non-legal, easy-to-understand language, and the newest edition features an accessible and engaging new, colorful layout to better highlight the important content as well as online support for better reader comprehension. Pharmacy Practice and the Law, Seventh Edition is the essential resource both for teaching the facts of pharmacy law and for stimulating critical thinking issues in pharmacy law. The Seventh Edition of this best-selling text includes updates to account for new legal, regulatory, and policy developments. Pharmacy Practice and the Law, Seventh Edition provides background, history, and discussion of the law to enable students not only to learn the facts, but to help them understand, apply, and critically evaluate the information and how it will affect their practice. Pharmacy Practice and the Law, Seventh Edition is the essential resource both for teaching the facts of pharmacy law and for stimulating critical thinking issues in pharmacy law. Features * Challenging open-ended discussion questions * Edited cases in each chapter * Citations and documentation for all laws, court cases, and regulations * Non-legal, easy-to-understand language is used to discuss critical issues * Accessible and engaging new, colorful layout * Online interactive activities to aid and enhance reader comprehension Instructor Resources: Case Studies, Instructor's Manual, PowerPoint Presentations, Test Bank Student Resources: Companion Website including: Case Studies, Crossword Puzzles, Interactive Flashcards, Interactive Glossary, Matching Exercises Each new printed textbook copy of Pharmacy Practice and the Law, Seventh Edition includes an access code card with login information for the accompanying Student Companion Website. For more information on the Companion Website or to purchase individual access click here. Available February 2013.
