Download or read book Pharmaceutical Product Licensing written by Brian R. Matthews and published by CRC Press. This book was released on 1991-05-31 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.
Download or read book Premerger Notification Practice Manual written by Bruce J. Prager and published by . This book was released on 1991 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patent Law and Intellectual Property in the Medical Field written by Aggarwal, Rashmi and published by IGI Global. This book was released on 2017-06-30 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growing presence of technology has created significant changes within the healthcare industry. With the ubiquity of these technologies, there is now an increasing need for more advanced legal procedures. Patent Law and Intellectual Property in the Medical Field is a pivotal reference source for the latest research in support of developing convergent and interoperable systems to increase awareness and applicability of legal aspects in the medical field. Featuring extensive coverage on relevant areas such as compulsory licensing, parallel importing, and protection law, this publication is an ideal resource for researchers, medical and law professionals, academics, graduate students, and practitioners engaged in medical practice.
Download or read book FTO freedom to Operate in the Pharmaceutical Industry written by Hirotaka Nonaka and published by Nomos Verlagsgesellschaft. This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Key features of innovation in the pharmaceutical industry -- How to achieve freedom to operate (FTO) -- Dealing with adverse patents -- Structure and operation of FTO-licensing markets in the parmaceutical industry -- FTO-licensing between a venture business company for innovative drug development and a pharmaceutical company.
Download or read book Confidential Prospectus written by China-America Banking and Mercantile Co and published by . This book was released on 1901 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Alliance Revolution written by Benjamin Gomes-Casseres and published by Harvard University Press. This book was released on 1996 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than we ever anticipated, alliances among firms are changing the way business is conducted, particularly in the global, high-technology sector. The reasons are clear: companies must increasingly pool their capabilities to succeed in ever more complex and rapidly changing businesses. But the consequences for managers and for the economy have so far been underestimated. In this new book, Benjamin Gomes-Casseres presents the first in-depth account of the new world of business alliances and shows how collaboration has become part of the very fabric of modern competition. Alliances, he argues, create new units of competition that do battle with one another and with traditional single firms. The flexible capabilities of these multi-firm constellations give them advantages over single firms in certain contexts, offsetting the advantage of a single firm's unified control. When managed effectively, alliances can strengthen a firm's competitive advantage and narrow the gap between leading firms and second-tier players. This often results in intensified rivalry, and the competition within an industry is transformed. Alliances often spread swiftly through an industry as firms jockey for advantage. Yet the very spread of alliances increases their costs and poses new limits on their use. Gomes-Casseres concludes that firms need to manage their constellations to enhance collaboration within their groups, while raising what he calls "barriers to collaboration" for rivals. These ideas are developed and illustrated through original case studies of alliances among U.S., Japanese, and European firms in electronics and computers, including Xerox, IBM, and Fujitsu as well as other small and large companies. The book should be of interest to business academics, managers, and general readers concerned with contemporary capitalism.
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Download or read book Successful Technology Licensing written by World Intellectual Property Organization and published by WIPO. This book was released on 2014-07-17 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Manual focuses on issues essential for understanding licensing, including: the context in which licensing may occur; key terms of a licensing agreement and negotiation methods; and how to prepare for and negotiate a win-win licensing contract.
Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Martindale written by Sean C. Sweetman and published by . This book was released on 2006-01-01 with total page 3335 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is thirty-fifth edition of Martindale, which provides reliable, and evaluated information on drugs and medicines used throughout the world. It contains encyclopaedic facts about drugs and medicines, with: 5,500 drug monographs; 128,000 preparations; 40,700 reference citations; 10,900 manufacturers. There are synopses of disease treatments which enables identification of medicines, the local equivalent and the manufacturer. It also Includes herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines. Based on published information and extensively referenced
Download or read book Intellectual Property in Molecular Medicine written by Salim Mamajiwalla and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents are an important way of protecting inventions in the pharmaceutical and biotechnology industries. However, intellectual property law reforms have not kept pace with the rapid advances in genomics, synthetic biology, and stem cell research. Meanwhile, universities are increasingly spinning off companies that use these technologies, requiring the academic scientists involved to gain an understanding of intellectual property law and the patent system as it applies to biomedical innovations. This collection from Cold Spring Harbor Perspectives in Medicine aims to provide a clear, current, and comprehensive understanding of biomedical intellectual property and the laws that protect it. The contributors describe patent laws and practices in the United States, Canada, Australia, and the European Union. They explain the roles of regulatory agencies in intellectual property, various opinions on the patentability of biological materials (e.g., DNA and stem cells), and the implications of recent court decisions (e.g., the Myriad case). Practical issues related to licensing agreements and patent applications are also discussed. The authors offer guidance on the criteria for patent eligibility (e.g., utility, nonobviousness, and novelty), issues related to timing and possession, and rules for determining inventorship. Other topics include trade secrets, research exemptions, and the protection of traditional knowledge related to biological resources. This volume will serve as an essential reference for all scientists, physicians, and technology transfer professionals seeking to navigate the complex rules, regulations, and procedures concerning intellectual property in biotech and pharma.
Download or read book Open Source Licensing written by Lawrence E. Rosen and published by Prentice Hall. This book was released on 2005 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: "I have studied Rosen's book in detail and am impressed with its scope and content. I strongly recommend it to anybody interested in the current controversies surrounding open source licensing." --John Terpstra, Samba.org; cofounder, Samba-Team "Linux and open source software have forever altered the computing landscape. The important conversations no longer revolve around the technology but rather the business and legal issues. Rosen's book is must reading for anyone using or providing open source solutions." --Stuart Open Source Development Labs A Complete Guide to the Law of Open Source for Developers, Managers, and Lawyers Now that open source software is blossoming around the world, it is crucial to understand how open source licenses work--and their solid legal foundations. Open Source Initiative general counsel Lawrence Rosen presents a plain-English guide to open source law for developers, managers, users, and lawyers. Rosen clearly explains the intellectual property laws that support open source licensing, carefully reviews today's leading licenses, and helps you make the best choices for your project or organization. Coverage includes: Explanation of why the SCO litigation and other attacks won't derail open source Dispelling the myths of open source licensing Intellectual property law for nonlawyers: ownership and licensing of copyrights, patents, and trademarks "Academic licenses" BSD, MIT, Apache, and beyond The "reciprocal bargain" at the heart of the GPL Alternative licenses: Mozilla, CPL, OSL and AFL Benefits of open source, and the obligations and risks facing businesses that deploy open source software Choosing the right license: considering business models, product architecture, IP ownership, license compatibility issues, relicensing, and more Enforcing the terms and conditions of open source licenses Shared source, eventual source, and other alternative models to open source Protecting yourself against lawsuits
