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Author: José Luis Valverde
Publisher: IOS Press
ISBN: 9781586038403
Category : Law
Languages : en
Pages : 176
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Book Description
"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.
Author: José Luis Valverde
Publisher: IOS Press
ISBN: 9781586038403
Category : Law
Languages : en
Pages : 176
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Book Description
"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.
Author: Great Britain: Parliament: House of Commons: Health Committee
Publisher: The Stationery Office
ISBN: 9780215024572
Category : Political Science
Languages : en
Pages : 556
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Book Description
Incorporating HC 1030-i to iii.
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 12
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Book Description
Author: Congressional Budget Office
Publisher: Lulu.com
ISBN: 1304121445
Category : Science
Languages : en
Pages : 65
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Book Description
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...
Author: Holly Fernandez Lynch
Publisher: Columbia University Press
ISBN: 0231540078
Category : Business & Economics
Languages : en
Pages : 499
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
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Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Charlene Cho
Publisher:
ISBN: 9781641059718
Category : Medical instruments and apparatus
Languages : en
Pages : 389
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Book Description
"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"--
Author: Martha A. Embrey
Publisher:
ISBN: 9781565495876
Category : Drugs
Languages : en
Pages : 0
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Book Description
Managing Drug Supply (MDS) is the leading reference on how to manage essential medicines in developing countries. MDS was originally published in 1982; it was revised in 1997 with over 10,000 copies distributed in over 60 countries worldwide. The third edition, MDS-3: Managing Access to Medicines and Health Technologies reflects the dramatic changes in politics and public health priorities, advances in science and medicine, greater focus on health care systems, increased donor funding, and the advent of information technology that have profoundly affected access to essential medicines over the past 14 years. Nearly 100 experts from a wide range of disciplines and virtually every corner of the world have contributed to this third edition. In addition to many new country studies, references, and extensive revisions, MDS-3 offers new chapters on areas such as pharmaceutical benefits in insurance programs, pricing, intellectual property, drug seller initiatives, and traditional and complementary medicine. The revisions and new chapters echo the wide variety of issues that are important to health practitioners and policy makers today. MDS-3 will be a valuable tool in the effort to ensure universal access to quality medicines and health technologies and their appropriate use.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309458889
Category : Science
Languages : en
Pages : 115
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Book Description
The potential misuse of advances in life sciences research is raising concerns about national security threats. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies examines the U.S. strategy for reducing biosecurity risks in life sciences research and considers mechanisms that would allow researchers to manage the dissemination of the results of research while mitigating the potential for harm to national security.
Author: Katia Fach Gomez
Publisher: Kluwer Law International B.V.
ISBN: 9403501359
Category : Law
Languages : en
Pages : 512
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Book Description
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
