Author : Brian R. Matthews
Publisher : CRC Press
Page : 383 pages
File Size : 48,46 MB
Release : 1991-05-31
Category : Medical
ISBN : 113499494X
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.
Author : American Bar Association. Premerger Notification Subcommittee
Publisher :
Page : 178 pages
File Size : 23,37 MB
Release : 1985
Category : Antitrust law
ISBN :
This work summarizes and discusses informal FTC interpretations of premerger notification requirements in the Hart-Scott-Rodino Act of 1976 and other laws.
Author : Javed Ali
Publisher : Academic Press
Page : 287 pages
File Size : 50,81 MB
Release : 2021-11-14
Category : Medical
ISBN : 0128222239
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
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
Page : 235 pages
File Size : 22,83 MB
Release : 2018-03-01
Category : Medical
ISBN : 0309468086
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.
Author : Salim Mamajiwalla
Publisher :
Page : 0 pages
File Size : 21,15 MB
Release : 2015
Category : Medical
ISBN : 9781621820833
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.
Author : Benjamin Gomes-Casseres
Publisher : Harvard University Press
Page : 330 pages
File Size : 48,66 MB
Release : 1996
Category : Business & Economics
ISBN : 9780674016477
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.
Author :
Publisher : World Health Organization
Page : 70 pages
File Size : 44,59 MB
Release : 2020-09-29
Category : Business & Economics
ISBN : 9240011870
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.
Author : Christopher M. Riley
Publisher : Elsevier
Page : 363 pages
File Size : 22,14 MB
Release : 1996-05-29
Category : Science
ISBN : 0080530354
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.
Author : Institute of Medicine
Publisher : National Academies Press
Page : 442 pages
File Size : 17,38 MB
Release : 2011-04-03
Category : Medical
ISBN : 0309158060
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.
Author : Alexander Schuhmacher
Publisher : John Wiley & Sons
Page : 511 pages
File Size : 27,51 MB
Release : 2016-04-11
Category : Science
ISBN : 3527339132
This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.
