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Key Issues In Pharmaceuticals Law
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Book Synopsis Key Issues in Pharmaceuticals Law by : José Luis Valverde
Download or read book Key Issues in Pharmaceuticals Law written by José Luis Valverde and published by IOS Press. This book was released on 2007 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The focus of Key Issues in Pharmaceuticals Law is on the ongoing achievement of an authentic world code for medicinal products - a so-called "Pharmacopoeia"--Through scientific technical harmonization. The legal dimension of medicinal products conditions the whole sector and it acquires a global dimension through the demand to protect people's health. Hence it is necessary to go forward to total harmonization of all its aspects. A global legal statute for medicinal products is justified by the very nature of the product, by its social control and the need for it to circulate freely, although limitations can be accepted, for reasons of solidarity with less favored populations. Awareness must arise that the challenge for healthcare is not going to find an adequate answer at the world level without a qualitative change in the world organization of the UN. The globalized world we live in demands reinforced continental solidarity, if we are to confront the common problems and bring about international order. A scientific technical code on the quality of medicinal products is essential for a statute on medicines. That code is the Pharmacopoeia."--Publisher.
Book Synopsis International Pharmaceutical Law and Practice by : Adrian Zahl
Download or read book International Pharmaceutical Law and Practice written by Adrian Zahl and published by . This book was released on 2004 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Contemporary Issues in Pharmaceutical Patent Law by : Bryan Mercurio
Download or read book Contemporary Issues in Pharmaceutical Patent Law written by Bryan Mercurio and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection explores the complexities associated with the intersection of pharmaceutical law and policy and public health. Focusing on patent and relevant regulatory laws, the collection provides a comprehensive overview of the most important and pressing issues governments are currently facing in regards to ensuring access to medicines at an affordable cost. Each chapter focuses on a separate issue and offers clear, balanced and detailed analysis of the international framework, trends and available policy options.
Book Synopsis The Law and Ethics of the Pharmaceutical Industry by : M.N.G. Dukes
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
Book Synopsis FDA in the Twenty-First Century by : Holly Fernandez Lynch
Download or read book FDA in the Twenty-First Century written by Holly Fernandez Lynch and published by Columbia University Press. This book was released on 2015-09-08 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Book Synopsis Conflict of Interest in Medical Research, Education, and Practice by : Institute of Medicine
Download or read book Conflict of Interest in Medical Research, Education, and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Book Synopsis Drug Safety by : United States. General Accounting Office
Download or read book Drug Safety written by United States. General Accounting Office and published by . This book was released on 2001 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Jungle written by Upton Sinclair and published by . This book was released on 1920 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Regulating the practice of pharmacy by : California
Download or read book Regulating the practice of pharmacy written by California and published by . This book was released on 1913 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Roman Law in Context by : David Johnston
Download or read book Roman Law in Context written by David Johnston and published by Cambridge University Press. This book was released on 1999-09-28 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: Roman Law in Context explains how Roman law worked for those who lived by it, by viewing it in the light of the society and economy in which it operated. The book discusses three main areas of Roman law and life: the family and inheritance; property and the use of land; commercial transactions and the management of businesses. It also deals with the question of litigation and how readily the Roman citizen could assert his or her legal rights in practice. In addition it provides an introduction to using the main sources of Roman law. The book ends with an epilogue discussing the role of Roman law in medieval and modern Europe, a bibliographical essay, and a glossary of legal terms. The book involves the minimum of legal technicality and is intended to be accessible to students and teachers of Roman history as well as interested general readers.
Book Synopsis The SAGE Guide to Key Issues in Mass Media Ethics and Law by : William A. Babcock
Download or read book The SAGE Guide to Key Issues in Mass Media Ethics and Law written by William A. Babcock and published by SAGE Publications. This book was released on 2015-03-23 with total page 965 pages. Available in PDF, EPUB and Kindle. Book excerpt: The SAGE Guide to Key Issues in Mass Media Ethics and Law is an authoritative and rigorous two-volume, issues-based reference set that surveys varied views on many of the most contentious issues involving mass media ethics and the law. Divided into six thematic sections covering information from contrasting ethical responsibly and legal rights for both speech and press, newsgathering and access, and privacy to libelous reporting, business considerations, and changing rules with social media and the Internet, the information in this guide is extremely relevant to a variety of audiences. This guide specifically focuses on matters that are likely to be regular front-page headlines concerning topics such as technological threats to privacy, sensationalism in media coverage of high-profile trials, cameras in the courtroom, use of confidential sources, national security concerns and the press, digital duplication and deception, rights of celebrities, plagiarism, and more. Collectively, this guide assesses key contentious issues and legal precedents, noting current ethical and legal trends and likely future directions. Features: Six thematic sections consist of approximately a dozen chapters each written by eminent scholars and practitioners active in the field. Sections open with a general Introduction by the volume editors and conclude with a wrap-up “Outlook” section to highlight likely future trends. Chapters follow a common organizational outline of a brief overview of the issue at hand, historical background and precedent, and presentation of various perspectives (pro, con, mixed) to the issue. “See also” cross references guide readers to related chapters and references and further readings guide users to more in-depth resources for follow-up. This reference guide is an excellent source for the general public, students, and researchers who are interested in expanding their knowledge in mass media and the ethics and law surrounding it.
Book Synopsis World Drug Report 2019 (Set of 5 Booklets) by : United Nations Office on Drugs and Crime
Download or read book World Drug Report 2019 (Set of 5 Booklets) written by United Nations Office on Drugs and Crime and published by United Nations. This book was released on 2019-06-26 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 2019 World Drug Report will include an updated overview of recent trends on production, trafficking and consumption of key illicit drugs. The Report contains a global overview of the baseline data and estimates on drug demand and supply and provides the reference point for information on the drug situation worldwide.
Book Synopsis Research and Development in the Pharmaceutical Industry (A CBO Study) by : Congressional Budget Office
Download or read book Research and Development in the Pharmaceutical Industry (A CBO Study) written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
Book Synopsis 60 Years of the New York Convention by : Katia Fach Gomez
Download or read book 60 Years of the New York Convention written by Katia Fach Gomez and published by Kluwer Law International B.V.. This book was released on 2019-03-22 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Worldwide interest in the recognition and enforcement of arbitral awards has never been higher, and the New York Convention of 1958, currently adhered to by 159 States including the major trading nations, remains the most successful treaty in this area of commercial law. This incomparable book, marking the Convention’s 60th anniversary, provides a fully updated analysis of the Convention’s application from international, comparative, and national perspectives. Drawing on a global conference held in Seville in April 2018 that was actively supported by UNCITRAL, the book’s 27 chapters, by highly qualified international practitioners and academics from different jurisdictions, address the subject with critical eyes, well aware of current developments and future challenges in the field of arbitration. Among the issues and topics covered are the following: Multi-tiered dispute resolution clauses. Applicability of the UN Convention on the Use of Electronic Communications in International Contracts. Complexities of enforcing orders determined by software. Enforcement of annulled awards. European Union law and the New York Convention. Enforcing awards against States and State entities. Sovereign immunity as a ground to refuse compliance with investor-State awards; Enforcement against non-signatories. Public policy exception. Arbitrating and enforcing foreign awards in specific countries and regions, including China, sub-Saharan Africa, and the ASEAN countries. Ample reference is made throughout to leading cases and practice. Familiarity with the intricacies of the New York Convention, as the most universally acknowledged framework in which cross-border economic exchanges can flourish, is essential for judges, practitioners, legal staff, business people, and scholars working with or applying international commercial arbitration anywhere in the world. This book’s combination of highly thought-provoking topics and the depth with which they are addressed will prove invaluable to all interested parties
Book Synopsis Health Professions Education by : Institute of Medicine
Download or read book Health Professions Education written by Institute of Medicine and published by National Academies Press. This book was released on 2003-07-01 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine study Crossing the Quality Chasm (2001) recommended that an interdisciplinary summit be held to further reform of health professions education in order to enhance quality and patient safety. Health Professions Education: A Bridge to Quality is the follow up to that summit, held in June 2002, where 150 participants across disciplines and occupations developed ideas about how to integrate a core set of competencies into health professions education. These core competencies include patient-centered care, interdisciplinary teams, evidence-based practice, quality improvement, and informatics. This book recommends a mix of approaches to health education improvement, including those related to oversight processes, the training environment, research, public reporting, and leadership. Educators, administrators, and health professionals can use this book to help achieve an approach to education that better prepares clinicians to meet both the needs of patients and the requirements of a changing health care system.
Book Synopsis The Affordable Care Act by : Tamara Thompson
Download or read book The Affordable Care Act written by Tamara Thompson and published by Greenhaven Publishing LLC. This book was released on 2014-12-02 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Patient Protection and Affordable Care Act (ACA) was designed to increase health insurance quality and affordability, lower the uninsured rate by expanding insurance coverage, and reduce the costs of healthcare overall. Along with sweeping change came sweeping criticisms and issues. This book explores the pros and cons of the Affordable Care Act, and explains who benefits from the ACA. Readers will learn how the economy is affected by the ACA, and the impact of the ACA rollout.
Book Synopsis Examining Core Elements of International Research Collaboration by : Institute of Medicine
Download or read book Examining Core Elements of International Research Collaboration written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-29 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: The globalization of science, engineering, and medical research is proceeding rapidly. The globalization of research has important implications for the U.S. research enterprise, for the U.S. government agencies, academic institutions, and companies that support and perform research, and for the world at large. As science and technology capabilities grow around the world, U.S.-based organizations are finding that international collaborations and partnerships provide unique opportunities to enhance research and training. At the same time, significant obstacles exist to smooth collaboration across national borders. Enhancing international collaboration requires recognition of differences in culture, legitimate national security needs, and critical needs in education and training. In response to these trends, the Government-University-Industry Research Roundtable (GUIRR) launched a Working Group on International Research Collaborations (I-Group) in 2008, following its meeting on New Partnerships on a Global Platform that June. As part of I-Group's continuing effort, a workshop on Examining Core Elements of International Research Collaboration was held July 26-27, 2010 in Washington, DC. One primary goal of the workshop is to better understand the risks involved in international research collaboration for organizations and individual participants, and the mechanisms that can be used to manage those risks. Issues to be addressed in the workshop include the following: (1) Cultural Differences and Nuances; (2) Legal Issues and Agreements; (3) Differences in Ethical Standards; (4) Research Integrity and the Responsible Conduct of Research; (5) Intellectual Property; (6) Risk Management; (7) Export Controls; and (8) Strategies for Developing Meaningful International Collaborations. The goal for the workshop and the summary, Examining Core Elements of International Research Collaboration, is to serve as an information resource for participants and others interested in international research collaborations. It will also aid I-Group in setting its future goals and priorities.
