Download or read book Understanding Legal Trends in the Life Sciences Industry written by Aspatore, Inc and published by Aspatore Books. This book was released on 2014-04-01 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding Legal Trends in the Life Sciences Industry provides an authoritative, insiders perspective on assisting clients with navigating domestic and international regulatory changes. Featuring experienced partners from law firms across the nation, these experts discuss various issues impacting the life sciences industry, such as transparency, technological advances, marketing regulations, and safety practices. These top lawyers offer specific advice on building portfolios to withstand competition, implementing strong security practices to protect information, and helping clients overcome enforcement challenges. From understanding the Mayo Collaborative Services v. Prometheus Labs, Inc. decision on patentability to updating clients about ongoing compliance issues, these experts discuss the impact of Supreme Court cases on the industry and help develop risk programs to prevent future problems. The different niches represented and the breadth of perspectives presented enable readers to get inside some of the great legal minds of today, as these experienced lawyers offer up their thoughts on the keys to success within this ever-changing field.
Download or read book AHLA The Fundamentals of Life Sciences Law Non Members written by and published by . This book was released on 2016 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, Second Edition, provides a solid grounding in the legal principles and issues inherent in this complex area. Both new practitioners and experienced attorneys alike will benefit from this unparalleled coverage.This new edition features contributions from some of the most experienced and respected practitioners of life sciences and health law. Whether you're looking for an introduction to this area, or you need a go-to reference on your shelf, the coverage includes:Regulation of DrugsRegulation of Medical DevicesRegulation of BiologicsClinical TrialsFraud and AbuseFederal AgenciesRegulation of Advertising, and Promotion of Drugs, Medical Devices, and BiologicsAntitrustPrivacyState RegulationIntellectual PropertyPayment and ReimbursementInternational IssuesLife Sciences Licensing Transaction
Download or read book Securities Law Practice written by Wendell De Keesee, 3rd and published by . This book was released on 2021-08-15 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The world is witnessing the big bang of scientific discovery, and biotech stocks are on fire!The bio-pharma industry employs over 4 million people just in the US. Potentially 100's of new little biotech companies will develop new generations of medicines and medical devices while creating vast numbers of new millionaires. The new Masters of Bioscience Law & Technology Mini-MBA certificate program, provides leading edge business skills, and leadership training to help propel your career forward. In recent years entrepreneurship has been added to many MBA curriculums, but starting your own business doesn't have to take two years in school and $100,000+ in tuition. To stimulate prospective leaders, this new program will encourage all applicants to be reviewed for scholarship opportunities. Register now for the online Bioscience Law & Technology Mini-MBA certificateNow is the time to jump in!The Biotech "Gold Rush" is On! What are you waiting for?VISIT us online.https://newlondoncrownpublishing.com/ Biomedical Business and Legal Management StrategiesLearn the business of biotechnology, how to start and manage biotechnology companies, and how to better service the needs of biotechnology companies.Going beyond simple 'science for non-scientists' or 'Mini-MBA' offerings, these four (4) parts books series describe the convergence of scientific, political, regulatory, and commercial factors that drive the biotechnology industry and define its scope.Study, learn, and explore biotechnology law, science and the biopharma industry! 1.Assess the potential therapeutic value of discoveries emanating from advanced research in the life sciences and understand ways to accelerate these discoveries into therapeutics, and medical devices. 2.Lead science-based organizations, including businesses and non-profits, with an understanding of research, business models, intellectual property and regulatory strategies. 3.Determine the most promising strategy for science-based organizations, including novel ways for expanding access to crucial investment funds and securities offerings. 4.Understand the financial underpinnings of investment decisions in the life sciences, including real-option approaches to investments, as well as the role of scientific, commercial, and regulatory uncertainties affecting biopharma companies.5.Develop approaches to novel therapeutics, including investment in neglected diseases, AI, nano technology, new biologics and medical devices.
Download or read book Life Sciences Law written by Barbara Schroeder de Castro Lopes and published by Dike Publishers. This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview and practical guidance in life sciences law to readers in Switzerland and worldwide. Focusing on medicinal products and medical devices, it follows the value chain from the bench to the market. The main topics addressed include recent regulatory developments and cross-cutting issues relevant for any phase of a product life cycle, such as intellectual property rights, commercial agreements, dispute resolution, incorporation and fundraising, competition law and data protection. Written for readers with diverse backgrounds such as in-house and external counsel, scientists, entrepreneurs, technology transfer professionals, engineers, investors and students, the book provides practical advice, case studies, references to further information, a glossary, and numerous graphs and tables to highlight key points. Though focusing on Swiss law, the book also reflects the international scope of life sciences-related transactions by referencing European Union law and presenting selected topics relevant for operations in the USA and China.
Download or read book Pharmaceutical and Biotech Patent Law written by Arnold & Porter Kaye Scholer Llp and published by . This book was released on 2019-06-07 with total page 1204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.
Download or read book Intellectual Property Rights and the Life Science Industries written by Graham Dutfield and published by World Scientific. This book was released on 2009 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to OC inventOCO life forms from scratch.
Download or read book Intellectual Property Rights and the Life Science Industries written by Graham Dutfield and published by . This book was released on 2009 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edit.
Download or read book Navigating Legal Issues in the Biotechnology Industry written by 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 Dual Use Research of Concern in the Life Sciences written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-10-01 with total page 115 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book LIFE SCIENCES AND INTELLECTUAL PROPERTY written by BIRD & BIRD. LLP and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Law and Policy of Healthcare Financing written by Wolf Sauter and published by Edward Elgar Publishing. This book was released on 2019 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the ways and extent to which systemic factors affect health outcomes with regard to quality, affordability and access to curative healthcare, this explorative book compares tax-funded Beveridge systems and insurance-based Bismarck systems. Containing contributions from national experts, The Law and Policy of Healthcare Financing charts and compares the merits of healthcare systems throughout 11 countries, from the UK to Colombia.
Download or read book Medical Devices Law and Regulation Answer Book written by Susan Onel and published by . This book was released on 2016-11 with total page 1112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
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 429 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 ANDA Litigation written by Kenneth L. Dorsney and published by American Bar Association. This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.
Download or read book Intellectual Property in the Life Sciences written by Paul England and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Subjects explored within the national chapters include small molecules, secondary patents, DNA and biologicals, patent infringement and enforcement, compulsory licensing, branding and designs, counterfeiting and know-how protection, and patenting and supplementary protection certificates (SPCs) in personalised medicine.
Download or read book A User s Guide to Intellectual Property in Life Sciences written by Paul England and published by Bloomsbury Publishing. This book was released on 2021-04-08 with total page 877 pages. Available in PDF, EPUB and Kindle. Book excerpt: Life Sciences is one of the most innovative and complex areas of law. It is currently undergoing a period of intense transformation, with companies facing an ever-increasing level of regulation as well as strict cost management in order to remain competitive and profitable. The latest in "A User's Guide to..." series it covers life sciences in relation to: - patents - copyright - trade marks; and - data protection The book covers UK law with references to significant EPO cases. A key part of the book is the coverage of case law. Case studies and detailed analysis of the key cases, eg the Kymab mouse case, the human genome sciences case, and the pregabalin case feature heavily helping to put this often complex area of law into context. Where appropriate and for comparison purposes, approaches of key foreign jurisdictions are summarised and for ease of use there are clearly signposted. A key text for practitioners specialising in life sciences and intellectual property in general and patents officers dealing with life sciences applications.
Download or read book Business Law Navigating Legal Issues in Commerce written by and published by Cybellium . This book was released on with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Welcome to the forefront of knowledge with Cybellium, your trusted partner in mastering the cutting-edge fields of IT, Artificial Intelligence, Cyber Security, Business, Economics and Science. Designed for professionals, students, and enthusiasts alike, our comprehensive books empower you to stay ahead in a rapidly evolving digital world. * Expert Insights: Our books provide deep, actionable insights that bridge the gap between theory and practical application. * Up-to-Date Content: Stay current with the latest advancements, trends, and best practices in IT, Al, Cybersecurity, Business, Economics and Science. Each guide is regularly updated to reflect the newest developments and challenges. * Comprehensive Coverage: Whether you're a beginner or an advanced learner, Cybellium books cover a wide range of topics, from foundational principles to specialized knowledge, tailored to your level of expertise. Become part of a global network of learners and professionals who trust Cybellium to guide their educational journey. www.cybellium.com
