Download or read book Navigating European Pharmaceutical Law written by Maria Isabel Manley and published by . This book was released on 2015 with total page 737 pages. Available in PDF, EPUB and Kindle. Book excerpt: An authoritative and comprehensive analysis of EU pharmaceutical law and the most controversial legal issues within the innovative industry, supported by case studies and practical guidance.
Download or read book Navigating European Pharmaceutical Law written by Maria Isabel Manley and published by Oxford University Press, USA. This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents / Dominic Adair, Greg Bacon, and Vanessa Rieu -- Clinical trials / Helen Middleton -- Procedures for obtaining a marketing authorisation and legal bases for application / Maria Isbel Manley and Libby Amos -- Pricing, reimbursement, and health technology appraisals (market access) / Maria Isabel Manley and Maria Georgiou -- Paediatrics / Georgia Gavriilidou -- Orphan drugs / Maria Isabel Manley and Chris Boyle -- Biological medicinal products and biosimilars / Dev Kumar and Lauren Wilks -- Regulatory data protection / Maria Isabel Manley and Grant Strachan -- Supplementary protection certificates / Maria Isabel Manley and Marina Vickers -- Maximisation of regulatory IP rights / Maria Isabel Manley and Marina Vickers -- The interaction between intellectual property law and competition law / Pat Treacy -- Access to information / Vincenzo Salvatore -- Litigating decisions of regulatory authorities / Kelyn Bacon, QC and Hugo Leith -- Pharmacovigilance / Maria Isabel Manley abd Edward Bray -- Data protection / Hazel Grant -- The promotion of medicinal products in the EU / Maria Isabel Manley and Libby Amos -- Borderline products / Maria Isabel Manley and Joanna Hook -- Product liability : the UK perspective / Mark Brown -- Pharmaceutical licensing and collaboration agreements : key consideration from the licensee's perspective / Jerry Temko -- Trade mark protection and enforcement in the pharmaceutical field / Sally Dunstan
Download or read book European Regulation of Medical Devices and Pharmaceuticals written by Nupur Chowdhury and published by Springer. This book was released on 2016-08-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation. In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.
Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
Download or read book EU Competition Law and Pharmaceuticals written by Wolf Sauter and published by Edward Elgar Publishing. This book was released on 2022-11-15 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book EU Competition Law and Intellectual Property Rights written by Pat Treacy and published by Edward Elgar Publishing. This book was released on 2024-07-05 with total page 555 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative book from one of the top experts in the field sets out a detailed and practical analysis of the complex and often fraught relationship between EU competition rules and intellectual property rights. It is an essential resource for competition lawyers litigating Tech and Pharma cases and advising companies in those sectors, for in-house counsel within those industries, and for IP lawyers needing to understand the competition aspects of licensing agreements. It is also an indispensable reference for courts, enforcement agencies and national competition authorities, as well as for scholars researching in the field.
Download or read book Supplementary Protection Certificates for Medicinal Products written by Georgia A. Roussou and published by Edward Elgar Publishing. This book was released on 2023-01-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.
Download or read book Evergreening Patent Exclusivity in Pharmaceutical Products written by Frantzeska Papadopoulou and published by Bloomsbury Publishing. This book was released on 2021-09-23 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.
Download or read book Practical Pharmaceutics written by Yvonne Bouwman-Boer and published by Springer. This book was released on 2015-08-24 with total page 873 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer Nature. This book was released on 2023-06-15 with total page 597 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Download or read book Bioeconomy for Sustainable Development written by Chetan Keswani and published by Springer Nature. This book was released on 2019-10-14 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: The current era of incredible innovations has made science and technology one of the most powerful tools to meet the goals of incremental prosperity for humans and sustainable development. The development of the biotech industry in any given country is shaped by the characteristics of the technology—particularly its close relation to scientific knowledge—and by country-specific factors—the level and nature of the scientific knowledge base, the institutional set-up, and the role assumed by the government—which influence the country's ability to exploit new opportunities and appropriate the respective results. This book presents an integrated approach for sustained innovation in various areas of biotechnology. Focusing mainly on the industrial, socio-economic and legal implications of biotechnological advances, it examines in detail not only the implications of IPR in omics-based research but also the ethical and intellectual standards and how these can be developed for sustained innovation. Integrating science and business, it offers a peek behind the scenes of the biotech industry and provides a comprehensive analysis of the foundations of the present day industry for students and professionals alike. The book is divided into three parts: Food and Agricultural BiotechnologyIndustrial BiotechnologyPharmaceutical Biotechnology
Download or read book The Patentability of Synthetic Biology Inventions written by Ilaria de Lisa and published by Springer Nature. This book was released on 2020-09-29 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses Synthetic Biology (SynBio), a new and promising biotechnology that has attracted much interest from both a scientific and a policy perspective. Yet, questions concerning the patentability of SynBio inventions have not been examined in detail so far; as a result, it remains unclear whether these inventions are patentable on the basis of current norms and case law. The book addresses this question, focusing especially on the subject matter’s eligibility and moral criteria. It provides an overview of the legislation and decisions applicable to SynBio patents and examines this new technology in view of the ongoing debate over the patentability of biotechnologies in general. The legal analysis is complemented by the practical examination of several patent applications submitted to the European and US patent offices (EPO and USPTO), and by an assessment of the patent issues that are likely to be raised by future SynBio developments.
Download or read book Law Regulation and Governance in the Information Society written by Maurizio Borghi and published by Taylor & Francis. This book was released on 2022-12-30 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited collection seeks to map the landscape of contemporary informational interests, to evaluate a range of recognised and putative rights and wrongs associated with modern information societies, and to consider how law, regulation, and governance should be deployed in response. New technologies and new applications constantly disrupt our values, our framing of our world, and our sense of where we are and who we are. In our ‘information societies’, we entertain mixed hopes and expectations, as well as significant fears and concerns. At the root of these, there are a number of informational interests, on the basis of which certain rights are claimed and particular wrongs denounced. This book addresses these interests, considering them as relating primarily to the integrity of the informational ecosystem, to the accessibility, accuracy, and authenticity of public information, and to our individual ability to control the outward and inward flows of information that relates directly to ourselves. Covering a wide range of subjects, the book’s interrogation of our contemporary information society is oriented around two questions: first, whether the information society in which we live is the kind of society that we think it should be and, second, if not, what we can reasonably expect law, regulation, and governance to do in providing the basis for improving it. This book will be of considerable interest to those working at the intersection of law and technology, as well as others concerned with the legal, political, and social aspects of our information society.
Download or read book Pharmaceutical Innovation Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.
Download or read book Contemporary Issues in Pharmaceutical Patent Law written by Bryan Mercurio and published by Taylor & Francis. This book was released on 2017-02-17 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges
Download or read book Governing Protecting and Regulating the Future of Genome Editing written by Santa Slokenberga and published by BRILL. This book was released on 2023-03-06 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.
